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Intervention Targeting Depressive Symptoms and Mental Rumination

Primary Purpose

Depression, Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Behavioral Activation treatment with Attention Training Technique
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • good understanding of French,
  • at least a medium level of depressive symptoms
  • report the presence of abstract rumination that generates negative mood.

Exclusion Criteria:

  • Having a history of psychotic disorder
  • Having a history of Bipolar disorder,
  • Having a history of severe brain trauma or epilepsy
  • with a moderate or severe substance use disorder other than tobacco (according to the DSM-V; i.e., showing 4 or more symptoms
  • with an organic illness (e.g. cancer),
  • with a concurrent additional psychotherapy,
  • with acute suicidal ideation,
  • with evidence of a significant change in medication within one month prior to baseline assessment.

Sites / Locations

  • Liège University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Simultaneous interventions

Sequential interventions

Sequential interventions in reverse order

Arm Description

In this condition, both interventions are proposed simultaneously. Condition 1 is spread over 5 weeks with 5 weekly laboratory sessions of 2-hours (one hour of BATD and one hour of ATT separated by a break). A 30-minutes ATT sessions at home were prescribed between sessions for a total of 5 laboratory ATT sessions and 5 at home ATT sessions.

In this condition, the interventions are introduced sequentially. Condition 2 is spread over 7 weeks with 8 weekly laboratory sessions, 7 sessions of 1-hour and one session of 2-hours (Sessions 4 with of one hour of ATT followed by one hour of BATD separated by a break). A six 30-minutes ATT sessions were prescribed between the first 4 sessions of ATT for a total of 4 laboratory ATT sessions and 6 at home ATT sessions.

In this condition, the interventions are introduced sequentially in the reverse order than the condition 2. Condition 3 is spread over 7 weeks with 8 weekly laboratory sessions, 7 sessions of 1-hour and one session of 2-hours (Sessions 5 with of one hour of BATD followed by one hour of ATT separated by a break). A six 30-minutes ATT sessions were prescribed between the 4 last sessions for a total of 4 laboratory ATT sessions and 6 at home ATT sessions.

Outcomes

Primary Outcome Measures

Depressive symptomatology
The Beck depression inventory- second edition (BDI-II) is a 21-items scale that assesses the severity of depressive symptoms during the last two weeks. The score may range from 0 to 63. Higher score indicates higher depressive symptoms (worse outcome).
Depressive symptomatology
The Beck depression inventory- second edition (BDI-II) is a 21-items scale that assesses the severity of depressive symptoms during the last two weeks.The score may range from 0 to 63. Higher score indicates higher depressive symptoms (worse outcome).
Depressive symptomatology
The Beck depression inventory- second edition (BDI-II) is a 21-items scale that assesses the severity of depressive symptoms during the last two weeks.The score may range from 0 to 63. Higher score indicates higher depressive symptoms (worse outcome).
Depressive symptomatology
The Beck depression inventory- second edition (BDI-II) is a 21-item scale that assesses the severity of depressive symptoms during the last two weeks.The score may range from 0 to 63. Higher score indicates higher depressive symptoms (worse outcome)
Activation
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. Activation may range from 0 to 42. Higher scores indicate greater activation level (better outcome)
Activation
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. Activation may range from 0 to 42. Higher scores indicate greater activation level (better outcome).
Activation
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. Activation may range from 0 to 42. Higher scores indicate greater activation level (better outcome)
Activation
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. Activation may range from 0 to 42. Higher scores indicate greater activation level (better outcome)
Avoidance
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The score on behavioral avoidance may range from 0 to 30. Higher scores indicate greater behavioral avoidance (worse outcome).
Avoidance
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The score on behavioral avoidance may range from 0 to 30. Higher scores indicate greater behavioral avoidance (worse outcome).
Avoidance
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The score on behavioral avoidance may range from 0 to 30. Higher scores indicate greater behavioral avoidance (worse outcome).
Avoidance
The Behavioral Activation for Depression Scale (BADS) is a 25-item scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The score on behavioral avoidance may range from 0 to 30. Higher scores indicate greater behavioral avoidance (worse outcome).
Social and Work Impairments
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The scores on Social and Work impairments may range from 0 to 30. Higher scores indicate higher Social and Work impairments respectively (worse outcomes)
Social and Work Impairments
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The scores on Social and Work impairments may range from 0 to 30. Higher scores indicate higher Social and Work impairments respectively (worse outcomes)
Social and Work Impairments
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The scores on Social and Work impairments may range from 0 to 30. Higher scores indicate higher Social and Work impairments respectively (worse outcomes)
Social and Work Impairments
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The scores on Social and Work impairments may range from 0 to 30. Higher scores indicate higher Social and Work impairments respectively (worse outcomes)
Mental Rumination
The Revised version of Mini-CERTS (RTMQ) is a 18-items scale assessing repetitive thinking. Three subscales are identified, the first is characterized by thoughts at an abstract, overgeneral level that address the causes and consequences of one's mood or condition (named AERT). The second is characterized by a mode of thinking centered on how one is presently feeling and experiencing the ongoing situation, and how a present experience unfolds (named CERTS). The third is characterized by a fluent and flexible thinking, with creative content (names CREATIVE). Higher scores indicate more abstract and general ruminative thinking for AERT (worse outcome), a more constructive way to ruminate for CERTS and CREATIVE (better outcome).
Mental Rumination
The Revised version of Mini-CERTS (RTMQ) is a 18-items scale assessing repetitive thinking. Three subscales are identified, the first is characterized by thoughts at an abstract, overgeneral level that address the causes and consequences of one's mood or condition (named AERT). The second is characterized by a mode of thinking centered on how one is presently feeling and experiencing the ongoing situation, and how a present experience unfolds (named CERTS). The third is characterized by a fluent and flexible thinking, with creative content (names CREATIVE). Higher scores indicate more abstract and general ruminative thinking for AERT (worse outcome), a more constructive way to ruminate for CERTS and CREATIVE (better outcome).
Mental Rumination
The Revised version of Mini-CERTS (RTMQ) is a 18-items scale assessing repetitive thinking. Three subscales are identified, the first is characterized by thoughts at an abstract, overgeneral level that address the causes and consequences of one's mood or condition (named AERT). The second is characterized by a mode of thinking centered on how one is presently feeling and experiencing the ongoing situation, and how a present experience unfolds (named CERTS). The third is characterized by a fluent and flexible thinking, with creative content (names CREATIVE). Higher scores indicate more abstract and general ruminative thinking for AERT (worse outcome), a more constructive way to ruminate for CERTS and CREATIVE (better outcome).
Mental Rumination
The Revised version of Mini-CERTS (RTMQ) is a 18-items scale assessing repetitive thinking. Three subscales are identified, the first is characterized by thoughts at an abstract, overgeneral level that address the causes and consequences of one's mood or condition (named AERT). The second is characterized by a mode of thinking centered on how one is presently feeling and experiencing the ongoing situation, and how a present experience unfolds (named CERTS). The third is characterized by a fluent and flexible thinking, with creative content (names CREATIVE). Higher scores indicate more abstract and general ruminative thinking for AERT (worse outcome), a more constructive way to ruminate for CERTS and CREATIVE (better outcome).
Well-being
The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) is a 14-items scale assessing mental well-being. The score may range from 14 to 70. Higher scores indicate higher mental well-being (better outcome).
Well-being
The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) is a 14-items scale assessing mental well-being. The score may range from 14 to 70. Higher scores indicate higher mental well-being (better outcome).
Well-being
The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) is a 14-items scale assessing mental well-being. The score may range from 14 to 70. Higher scores indicate higher mental well-being (better outcome).
Well-being
The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) is a 14-items scale assessing mental well-being. The score may range from 14 to 70. Higher scores indicate higher mental well-being (better outcome).
Anhedonia
The Savoring belief Inventory (SBI) is an 24-items scale assessing individuals' attitudes regarding savoring positive experiences. Three subscales related to three temporal orientations are identified, one related to the past (reminiscence), one related to the present moment (present), and one related to the future (anticipation) each represented by 8 items. Higher scores indicate higher level of approach and savor pleasant events (better outcome).
Anhedonia
The Savoring belief Inventory (SBI) is an 24-items scale assessing individuals' attitudes regarding savoring positive experiences. Three subscales related to three temporal orientations are identified, one related to the past (reminiscence), one related to the present moment (present), and one related to the future (anticipation) each represented by 8 items. Higher scores indicate higher level of approach and savor pleasant events (better outcome).
Anhedonia
The Savoring belief Inventory (SBI) is an 24-items scale assessing individuals' attitudes regarding savoring positive experiences. Three subscales related to three temporal orientations are identified, one related to the past (reminiscence), one related to the present moment (present), and one related to the future (anticipation) each represented by 8 items. Higher scores indicate higher level of approach and savor pleasant events (better outcome).
Anhedonia
The Savoring belief Inventory (SBI) is an 24-items scale assessing individuals' attitudes regarding savoring positive experiences. Three subscales related to three temporal orientations are identified, one related to the past (reminiscence), one related to the present moment (present), and one related to the future (anticipation) each represented by 8 items. Higher scores indicate higher level of approach and savor pleasant events (better outcome).
Cognitive control.
A computerized version of the Paced Auditory Serial- Addition Task was used as a measure of participants' updating abilities reflecting the working memory ability (PASAT). Higher scores suggest greater cognitive control ressources (better outcome).
Cognitive control.
A computerized version of the Paced Auditory Serial- Addition Task was used as a measure of participants' updating abilities reflecting the working memory ability (PASAT). Higher scores suggest greater cognitive control ressources (better outcome).
Cognitive control.
A computerized version of the Paced Auditory Serial- Addition Task was used as a measure of participants' updating abilities reflecting the working memory ability (PASAT). Higher scores suggest greater cognitive control ressources (better outcome).
Cognitive control.
A computerized version of the Paced Auditory Serial- Addition Task was used as a measure of participants' updating abilities reflecting the working memory ability (PASAT). Higher scores suggest greater cognitive control ressources (better outcome).
Attention Style Questionnaire
The Attentional Style Questionnaire (ASQ) is a 12- items scale assessing the capacity of an individual to maintain attention on task-related stimuli and not to be distracted by interfering stimuli. Two factors are identified: externally and internally oriented attention. Higher score indicating a marked bottom-up oriented attentional style, and a lower score indicating a marked top-down oriented attentional style.
Attention Style Questionnaire
The Attentional Style Questionnaire (ASQ) is a 12- items scale assessing the capacity of an individual to maintain attention on task-related stimuli and not to be distracted by interfering stimuli. Two factors are identified: externally and internally oriented attention. Higher score indicating a marked bottom-up oriented attentional style, and a lower score indicating a marked top-down oriented attentional style.
Attention Style Questionnaire
The Attentional Style Questionnaire (ASQ) is a 12- items scale assessing the capacity of an individual to maintain attention on task-related stimuli and not to be distracted by interfering stimuli. Two factors are identified: externally and internally oriented attention. Higher score indicating a marked bottom-up oriented attentional style, and a lower score indicating a marked top-down oriented attentional style.
Attention Style Questionnaire
The Attentional Style Questionnaire (ASQ) is a 12- items scale assessing the capacity of an individual to maintain attention on task-related stimuli and not to be distracted by interfering stimuli. Two factors are identified: externally and internally oriented attention. Higher score indicating a marked bottom-up oriented attentional style, and a lower score indicating a marked top-down oriented attentional style.

Secondary Outcome Measures

Multiple measures of Activation
Activation level was collected daily at the end of the day in a booklet with the following item "I have been an active person and have accomplished the goals I set for myself." accompanied by a visual Analogue Scale (ranging from left side : not at all to right side completely).
Multiple measures of reward motivation
Reward motivation was collected daily at the end of the day in a booklet with the following item "I am looking forward to some upcoming events or activities" accompanied by a visual Analogue Scale (ranging from left side : not at all to right side completely).
Multiple measures of Avoidance
Avoidance was collected daily at the end of the day in a booklet with the following item "Most of what I did was to escape from or avoid something unpleasant." accompanied by a visual Analogue Scale (ranging from left side : not at all to right side completely).
Multiple measures of focus of attention
Focus of attention was collected daily at the end of the day in a booklet with the following item "I focused my attention on myself rather than on my external environment." accompanied by a Visual Analogue Scale (ranging from left side : not at all to right side completely).
Multiple measures of awareness
Awareness was collected daily at the end of the day in a booklet with the following item "I was aware of my thoughts, body sensations, emotions and feelings" accompanied by a Visual Analogue Scale (ranging from left side : not at all to right side completely).
Multiple measures of Rumination
Rumination was collected daily at the end of the day in a booklet with the following item ". I spent a long time thinking over and over about my problems." accompanied by a Visual Analogue Scale (ranging from left side : not at all to right side completely).
Multiple individual measures of depressive symptoms
Two items assessing depressive symptoms were selected by the participant based on a idiographic approach. For exemple : "I had difficulty to experience pleasure in what I did", "I felt tired", "I felt like I was being punished", "I had a hard time getting interested in anything", "I've been irritable", "I felt guilty", "I felt sad". Depressive symptoms were collected at the end of the day in a booklet with two items accompanied by Visual Analogue Scales (ranging from left side : not at all to right side completely).
Multiple individual measures of functioning on disturbed area of life
Two items assessing disturbed functioning on area of life (e.g. social, professional, daily skills, hobbies, family, or relationships) were selected by the participant based on a idiographic approach. Depressive symptoms were collected at the end of the day in a booklet with two items accompanied by Visual Analogue Scales (ranging from left side : not at all to right side completely).
Multiple individual measures of personal complaints not related to the intervention.
One item assessing personal complaints (e.g. impulsivity, assertiveness, sleep) was selected by the participant based on a idiographic approach. Personal complaints was collected at the end of the day in a booklet with two items accompanied by Visual Analogue Scales (ranging from left side : not at all to right side completely).
Multiple measures of mood
Mood was collected daily at the end of the day in a booklet with items accompanied by a Visual Analogue Scale (ranging from left side : very negative to right side very positive).
Credibility and Expectancy
The Credibility and expectancy of treatment Questionnaire (CEQ) is a 6-items scale that assesses the therapy credibility who refers to the extent to which a treatment makes sense, is believable, convincing and logical, and the expectancy who refers to improvements that patients believe will occur with the intervention. Two subscales are identified: the Credibility and the Expectancy. Higher scores indicate better credibility and Expectancy from the patients (better outcome).
Therapeutic alliance
The Helping Alliance Questionnaire (HAQ) is a 8-items scale that assesses client-reported quality of the therapeutic alliance. Higher score indicated higher client satisfaction in the therapeutic alliance (better outcome).
Client Satisfaction
The Consumer Satisfaction Questionnaire (CSQ) is a 8-items scale that assesses client satisfaction with treatment. Higher score indicates greater satisfaction.
Client adherence and satisfaction
This post intervention interview focused on satisfaction with the organization (i.e., size of the group, rhythm of progression, materials given, sessions' length, sessions' frequency, location, equipment), with the content (i.e., pertinence to everyday life, helpfulness of tools and compatibility with their expectations, identification, applicability, improvement, feedback) and with the therapists (i.e., motivation, communication skills, knowledge, adaptation abilities).

Full Information

First Posted
October 6, 2020
Last Updated
March 8, 2021
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT04595539
Brief Title
Intervention Targeting Depressive Symptoms and Mental Rumination
Official Title
Does Attention Training Technique Enhance the Efficacy of Behavioral Activation Treatment for Depression: A Multiple Baseline Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to investigate the combine effects of Behavioral Activation and Attention Training on depression, well-being and other processes involved in depression as rumination. A multiple baseline design is followed with multiple idiographic assessments, in addition to a pre-post and follow-up standardized assessment design.
Detailed Description
Major depressive disorder (MDD) is one of the most prevalent mental disorders, as well as one of the leading causes of disability worldwide. Behavioral activation is an empirically validated treatment for depression associated with medium effect size. The rationale of behavioral activation is to increase activation and reduce avoidance in order to reduce depressive affects. In parallel, Attention Training Techniques (ATT) is also an empirically validated treatment for depression. The rationale of ATT is to attenuate the self-focused attention and increase flexible attentional control over information processing to reduce depressive affects. ATT could target specific cognitive factors that are not changed through traditional interventions, and might enhance treatment outcomes for clinical and subclinical depressed when used in adjunct to psychotherapy. Then, the use of ATT may be a promising avenue to increase effectiveness of behavioral activation treatment. The aims of the study are multiple. First, to measure the treatment feasibility and adherence of different treatment combinations and to measure it throughout the study. Second, to investigate the efficacy of Behavioral Activation Therapy for Depression combined with Attention Training sessions in subclinical and clinical depressed participants. Third, to investigate the mechanisms of change of both interventions. The design will follow an "A1-B-A2'" design. Daily ideographic measures will be collected during all phases. Phase A1 and A2 are non-interventional phases of baseline and follow-up period respectively. Participants are randomly allocated to baseline lengths of 7, 10 and 15 days. Phase B is the intervention phase ranging from 5 weeks to 7 weeks. Three conditions exist with participants randomly allocated to one of these conditions. The intervention is provided in individual once a week. The first condition is a combination of 5 weeks of behavioral activation treatment for depression (BATD) and Attention Training technique (ATT)(2 hours/week). The second condition is 3 weeks of ATT followed by 5 weeks of BATD (1 hour/week), and the third is 5 weeks of BATD followed by 3 weeks of ATT (1 hour/week). Nomothetic standardized measures were also collected at pre-treatment (T0), after treatment (T1), after two weeks (T2) and 3 months later (T3). The investigators hypothesized that the three proposed conditions will have an effect on the following target variables: activation, avoidance, reward motivation, self-focused attention, awareness as well as on transfer measures: depressive symptoms, rumination, anhedonia, well-being, social and work impairments, and cognitive control (2) changes in the target variables should preceded changes in the transfer measures (3) the therapeutic effects would be greater and faster when the treatments are combined than when they are offered sequentialy (i.e., in condition 1 versus conditions 2 and, (4) the therapeutic effect observed in Phase B was maintained in follow-up. Target measures were expected to change with the introduction of intervention in comparison to baseline phase. In Condition of combination, the investigators expected to observe in Phase B an enhancement of activation, awareness and reward motivation and a decrease in avoidance and self-focused attention in comparison to the baseline phase. In Condition 2 with ATT sessions followed by BA sessions, the investigators expected to observe a reduction of self-focus attention, and an enhancement of awareness with the introduction of ATT, and an enhancement of activation and reward motivation and a reduction of avoidance with the introduction of BA. In Condition 3 with BA sessions followed by ATT sessions, the investigators expected the opposite pattern of change with first an enhancement of activation and reward motivation and a reduction of avoidance with the introduction of BA in comparison to baseline and then a reduction of self-focus attention, and an enhancement of awareness with the introduction of ATT in comparison to baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
A blinding procedure was used for the pre-post evaluations: interviews were recorded and each video or sound recording was evaluated at the end of the study by one (or two) independent evaluator who was unaware of the recordings' assessment time.
Allocation
Randomized
Enrollment
13 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Simultaneous interventions
Arm Type
Experimental
Arm Description
In this condition, both interventions are proposed simultaneously. Condition 1 is spread over 5 weeks with 5 weekly laboratory sessions of 2-hours (one hour of BATD and one hour of ATT separated by a break). A 30-minutes ATT sessions at home were prescribed between sessions for a total of 5 laboratory ATT sessions and 5 at home ATT sessions.
Arm Title
Sequential interventions
Arm Type
Experimental
Arm Description
In this condition, the interventions are introduced sequentially. Condition 2 is spread over 7 weeks with 8 weekly laboratory sessions, 7 sessions of 1-hour and one session of 2-hours (Sessions 4 with of one hour of ATT followed by one hour of BATD separated by a break). A six 30-minutes ATT sessions were prescribed between the first 4 sessions of ATT for a total of 4 laboratory ATT sessions and 6 at home ATT sessions.
Arm Title
Sequential interventions in reverse order
Arm Type
Experimental
Arm Description
In this condition, the interventions are introduced sequentially in the reverse order than the condition 2. Condition 3 is spread over 7 weeks with 8 weekly laboratory sessions, 7 sessions of 1-hour and one session of 2-hours (Sessions 5 with of one hour of BATD followed by one hour of ATT separated by a break). A six 30-minutes ATT sessions were prescribed between the 4 last sessions for a total of 4 laboratory ATT sessions and 6 at home ATT sessions.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation treatment with Attention Training Technique
Intervention Description
The BATD includes the development of a shared formulation, psychoeducation, self-monitoring of daily activities, identifying "depressed behaviours", developing alternative goal orientated behaviours, scheduling of valued activities, and problem solving around difficulties implementing scheduled activities. Wells's Attention Training is a task designed to train selective attention to specific information by training individuals to attend to multiple auditory external sources. In addition to auditory exercices, the ATT sessions included psychoeducation, discussion around rumination (e.g. controllability, usefulness), self-report evaluation of self-focused before and after the auditory exercices, and transfer to everyday life.
Primary Outcome Measure Information:
Title
Depressive symptomatology
Description
The Beck depression inventory- second edition (BDI-II) is a 21-items scale that assesses the severity of depressive symptoms during the last two weeks. The score may range from 0 to 63. Higher score indicates higher depressive symptoms (worse outcome).
Time Frame
up to 72 hours before treatment
Title
Depressive symptomatology
Description
The Beck depression inventory- second edition (BDI-II) is a 21-items scale that assesses the severity of depressive symptoms during the last two weeks.The score may range from 0 to 63. Higher score indicates higher depressive symptoms (worse outcome).
Time Frame
up to 72 hours after treatment
Title
Depressive symptomatology
Description
The Beck depression inventory- second edition (BDI-II) is a 21-items scale that assesses the severity of depressive symptoms during the last two weeks.The score may range from 0 to 63. Higher score indicates higher depressive symptoms (worse outcome).
Time Frame
Two weeks after treatment
Title
Depressive symptomatology
Description
The Beck depression inventory- second edition (BDI-II) is a 21-item scale that assesses the severity of depressive symptoms during the last two weeks.The score may range from 0 to 63. Higher score indicates higher depressive symptoms (worse outcome)
Time Frame
Three months after treatment
Title
Activation
Description
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. Activation may range from 0 to 42. Higher scores indicate greater activation level (better outcome)
Time Frame
up to 72 hours before treatment
Title
Activation
Description
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. Activation may range from 0 to 42. Higher scores indicate greater activation level (better outcome).
Time Frame
up to 72 hours after treatment
Title
Activation
Description
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. Activation may range from 0 to 42. Higher scores indicate greater activation level (better outcome)
Time Frame
Two weeks after treatment
Title
Activation
Description
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. Activation may range from 0 to 42. Higher scores indicate greater activation level (better outcome)
Time Frame
Three months after treatment
Title
Avoidance
Description
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The score on behavioral avoidance may range from 0 to 30. Higher scores indicate greater behavioral avoidance (worse outcome).
Time Frame
up to 72 hours before treatment
Title
Avoidance
Description
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The score on behavioral avoidance may range from 0 to 30. Higher scores indicate greater behavioral avoidance (worse outcome).
Time Frame
up to 72 hours after treatment
Title
Avoidance
Description
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The score on behavioral avoidance may range from 0 to 30. Higher scores indicate greater behavioral avoidance (worse outcome).
Time Frame
Two weeks after treatment
Title
Avoidance
Description
The Behavioral Activation for Depression Scale (BADS) is a 25-item scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The score on behavioral avoidance may range from 0 to 30. Higher scores indicate greater behavioral avoidance (worse outcome).
Time Frame
Three months after treatment
Title
Social and Work Impairments
Description
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The scores on Social and Work impairments may range from 0 to 30. Higher scores indicate higher Social and Work impairments respectively (worse outcomes)
Time Frame
up to 72 hours before treatment
Title
Social and Work Impairments
Description
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The scores on Social and Work impairments may range from 0 to 30. Higher scores indicate higher Social and Work impairments respectively (worse outcomes)
Time Frame
up to 72 hours after treatment
Title
Social and Work Impairments
Description
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The scores on Social and Work impairments may range from 0 to 30. Higher scores indicate higher Social and Work impairments respectively (worse outcomes)
Time Frame
Two weeks after treatment
Title
Social and Work Impairments
Description
The Behavioral Activation for Depression Scale (BADS) is a 25-items scale that assesses behavioral activation. Five subscales have been identified: Activation, Behavioral Avoidance, Rumination, Work/School Impairment and Social Impairment. The scores on Social and Work impairments may range from 0 to 30. Higher scores indicate higher Social and Work impairments respectively (worse outcomes)
Time Frame
Three months after treatment
Title
Mental Rumination
Description
The Revised version of Mini-CERTS (RTMQ) is a 18-items scale assessing repetitive thinking. Three subscales are identified, the first is characterized by thoughts at an abstract, overgeneral level that address the causes and consequences of one's mood or condition (named AERT). The second is characterized by a mode of thinking centered on how one is presently feeling and experiencing the ongoing situation, and how a present experience unfolds (named CERTS). The third is characterized by a fluent and flexible thinking, with creative content (names CREATIVE). Higher scores indicate more abstract and general ruminative thinking for AERT (worse outcome), a more constructive way to ruminate for CERTS and CREATIVE (better outcome).
Time Frame
up to 72 hours before treatment
Title
Mental Rumination
Description
The Revised version of Mini-CERTS (RTMQ) is a 18-items scale assessing repetitive thinking. Three subscales are identified, the first is characterized by thoughts at an abstract, overgeneral level that address the causes and consequences of one's mood or condition (named AERT). The second is characterized by a mode of thinking centered on how one is presently feeling and experiencing the ongoing situation, and how a present experience unfolds (named CERTS). The third is characterized by a fluent and flexible thinking, with creative content (names CREATIVE). Higher scores indicate more abstract and general ruminative thinking for AERT (worse outcome), a more constructive way to ruminate for CERTS and CREATIVE (better outcome).
Time Frame
up to 72 hours after treatment
Title
Mental Rumination
Description
The Revised version of Mini-CERTS (RTMQ) is a 18-items scale assessing repetitive thinking. Three subscales are identified, the first is characterized by thoughts at an abstract, overgeneral level that address the causes and consequences of one's mood or condition (named AERT). The second is characterized by a mode of thinking centered on how one is presently feeling and experiencing the ongoing situation, and how a present experience unfolds (named CERTS). The third is characterized by a fluent and flexible thinking, with creative content (names CREATIVE). Higher scores indicate more abstract and general ruminative thinking for AERT (worse outcome), a more constructive way to ruminate for CERTS and CREATIVE (better outcome).
Time Frame
Two weeks after treatment
Title
Mental Rumination
Description
The Revised version of Mini-CERTS (RTMQ) is a 18-items scale assessing repetitive thinking. Three subscales are identified, the first is characterized by thoughts at an abstract, overgeneral level that address the causes and consequences of one's mood or condition (named AERT). The second is characterized by a mode of thinking centered on how one is presently feeling and experiencing the ongoing situation, and how a present experience unfolds (named CERTS). The third is characterized by a fluent and flexible thinking, with creative content (names CREATIVE). Higher scores indicate more abstract and general ruminative thinking for AERT (worse outcome), a more constructive way to ruminate for CERTS and CREATIVE (better outcome).
Time Frame
Three months after treatment
Title
Well-being
Description
The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) is a 14-items scale assessing mental well-being. The score may range from 14 to 70. Higher scores indicate higher mental well-being (better outcome).
Time Frame
up to 72 hours before treatment
Title
Well-being
Description
The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) is a 14-items scale assessing mental well-being. The score may range from 14 to 70. Higher scores indicate higher mental well-being (better outcome).
Time Frame
up to 72 hours after treatment
Title
Well-being
Description
The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) is a 14-items scale assessing mental well-being. The score may range from 14 to 70. Higher scores indicate higher mental well-being (better outcome).
Time Frame
Two weeks after treatment
Title
Well-being
Description
The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) is a 14-items scale assessing mental well-being. The score may range from 14 to 70. Higher scores indicate higher mental well-being (better outcome).
Time Frame
Three months after treatment
Title
Anhedonia
Description
The Savoring belief Inventory (SBI) is an 24-items scale assessing individuals' attitudes regarding savoring positive experiences. Three subscales related to three temporal orientations are identified, one related to the past (reminiscence), one related to the present moment (present), and one related to the future (anticipation) each represented by 8 items. Higher scores indicate higher level of approach and savor pleasant events (better outcome).
Time Frame
up to 72 hours before treatment
Title
Anhedonia
Description
The Savoring belief Inventory (SBI) is an 24-items scale assessing individuals' attitudes regarding savoring positive experiences. Three subscales related to three temporal orientations are identified, one related to the past (reminiscence), one related to the present moment (present), and one related to the future (anticipation) each represented by 8 items. Higher scores indicate higher level of approach and savor pleasant events (better outcome).
Time Frame
up to 72 hours after treatment
Title
Anhedonia
Description
The Savoring belief Inventory (SBI) is an 24-items scale assessing individuals' attitudes regarding savoring positive experiences. Three subscales related to three temporal orientations are identified, one related to the past (reminiscence), one related to the present moment (present), and one related to the future (anticipation) each represented by 8 items. Higher scores indicate higher level of approach and savor pleasant events (better outcome).
Time Frame
Two weeks after treatment
Title
Anhedonia
Description
The Savoring belief Inventory (SBI) is an 24-items scale assessing individuals' attitudes regarding savoring positive experiences. Three subscales related to three temporal orientations are identified, one related to the past (reminiscence), one related to the present moment (present), and one related to the future (anticipation) each represented by 8 items. Higher scores indicate higher level of approach and savor pleasant events (better outcome).
Time Frame
Three months after treatment
Title
Cognitive control.
Description
A computerized version of the Paced Auditory Serial- Addition Task was used as a measure of participants' updating abilities reflecting the working memory ability (PASAT). Higher scores suggest greater cognitive control ressources (better outcome).
Time Frame
up to 72 hours before treatment
Title
Cognitive control.
Description
A computerized version of the Paced Auditory Serial- Addition Task was used as a measure of participants' updating abilities reflecting the working memory ability (PASAT). Higher scores suggest greater cognitive control ressources (better outcome).
Time Frame
up to 72 hours after treatment
Title
Cognitive control.
Description
A computerized version of the Paced Auditory Serial- Addition Task was used as a measure of participants' updating abilities reflecting the working memory ability (PASAT). Higher scores suggest greater cognitive control ressources (better outcome).
Time Frame
Two weeks after treatment
Title
Cognitive control.
Description
A computerized version of the Paced Auditory Serial- Addition Task was used as a measure of participants' updating abilities reflecting the working memory ability (PASAT). Higher scores suggest greater cognitive control ressources (better outcome).
Time Frame
Three months after treatment
Title
Attention Style Questionnaire
Description
The Attentional Style Questionnaire (ASQ) is a 12- items scale assessing the capacity of an individual to maintain attention on task-related stimuli and not to be distracted by interfering stimuli. Two factors are identified: externally and internally oriented attention. Higher score indicating a marked bottom-up oriented attentional style, and a lower score indicating a marked top-down oriented attentional style.
Time Frame
up to 72 hours before treatment
Title
Attention Style Questionnaire
Description
The Attentional Style Questionnaire (ASQ) is a 12- items scale assessing the capacity of an individual to maintain attention on task-related stimuli and not to be distracted by interfering stimuli. Two factors are identified: externally and internally oriented attention. Higher score indicating a marked bottom-up oriented attentional style, and a lower score indicating a marked top-down oriented attentional style.
Time Frame
up to 72 hours after treatment
Title
Attention Style Questionnaire
Description
The Attentional Style Questionnaire (ASQ) is a 12- items scale assessing the capacity of an individual to maintain attention on task-related stimuli and not to be distracted by interfering stimuli. Two factors are identified: externally and internally oriented attention. Higher score indicating a marked bottom-up oriented attentional style, and a lower score indicating a marked top-down oriented attentional style.
Time Frame
Two weeks after treatment
Title
Attention Style Questionnaire
Description
The Attentional Style Questionnaire (ASQ) is a 12- items scale assessing the capacity of an individual to maintain attention on task-related stimuli and not to be distracted by interfering stimuli. Two factors are identified: externally and internally oriented attention. Higher score indicating a marked bottom-up oriented attentional style, and a lower score indicating a marked top-down oriented attentional style.
Time Frame
Three months after treatment
Secondary Outcome Measure Information:
Title
Multiple measures of Activation
Description
Activation level was collected daily at the end of the day in a booklet with the following item "I have been an active person and have accomplished the goals I set for myself." accompanied by a visual Analogue Scale (ranging from left side : not at all to right side completely).
Time Frame
everyday through study completion (an average of 7 to 9 weeks)
Title
Multiple measures of reward motivation
Description
Reward motivation was collected daily at the end of the day in a booklet with the following item "I am looking forward to some upcoming events or activities" accompanied by a visual Analogue Scale (ranging from left side : not at all to right side completely).
Time Frame
everyday through study completion (an average of 7 to 9 weeks)
Title
Multiple measures of Avoidance
Description
Avoidance was collected daily at the end of the day in a booklet with the following item "Most of what I did was to escape from or avoid something unpleasant." accompanied by a visual Analogue Scale (ranging from left side : not at all to right side completely).
Time Frame
everyday through study completion (an average of 7 to 9 weeks)
Title
Multiple measures of focus of attention
Description
Focus of attention was collected daily at the end of the day in a booklet with the following item "I focused my attention on myself rather than on my external environment." accompanied by a Visual Analogue Scale (ranging from left side : not at all to right side completely).
Time Frame
everyday through study completion (an average of 7 to 9 weeks)
Title
Multiple measures of awareness
Description
Awareness was collected daily at the end of the day in a booklet with the following item "I was aware of my thoughts, body sensations, emotions and feelings" accompanied by a Visual Analogue Scale (ranging from left side : not at all to right side completely).
Time Frame
everyday through study completion (an average of 7 to 9 weeks)
Title
Multiple measures of Rumination
Description
Rumination was collected daily at the end of the day in a booklet with the following item ". I spent a long time thinking over and over about my problems." accompanied by a Visual Analogue Scale (ranging from left side : not at all to right side completely).
Time Frame
everyday through study completion (an average of 7 to 9 weeks)
Title
Multiple individual measures of depressive symptoms
Description
Two items assessing depressive symptoms were selected by the participant based on a idiographic approach. For exemple : "I had difficulty to experience pleasure in what I did", "I felt tired", "I felt like I was being punished", "I had a hard time getting interested in anything", "I've been irritable", "I felt guilty", "I felt sad". Depressive symptoms were collected at the end of the day in a booklet with two items accompanied by Visual Analogue Scales (ranging from left side : not at all to right side completely).
Time Frame
everyday through study completion (an average of 7 to 9 weeks)
Title
Multiple individual measures of functioning on disturbed area of life
Description
Two items assessing disturbed functioning on area of life (e.g. social, professional, daily skills, hobbies, family, or relationships) were selected by the participant based on a idiographic approach. Depressive symptoms were collected at the end of the day in a booklet with two items accompanied by Visual Analogue Scales (ranging from left side : not at all to right side completely).
Time Frame
everyday through study completion (an average of 7 to 9 weeks)
Title
Multiple individual measures of personal complaints not related to the intervention.
Description
One item assessing personal complaints (e.g. impulsivity, assertiveness, sleep) was selected by the participant based on a idiographic approach. Personal complaints was collected at the end of the day in a booklet with two items accompanied by Visual Analogue Scales (ranging from left side : not at all to right side completely).
Time Frame
everyday through study completion (an average of 7 to 9 weeks)
Title
Multiple measures of mood
Description
Mood was collected daily at the end of the day in a booklet with items accompanied by a Visual Analogue Scale (ranging from left side : very negative to right side very positive).
Time Frame
everyday through study completion (an average of 7 to 9 weeks)
Title
Credibility and Expectancy
Description
The Credibility and expectancy of treatment Questionnaire (CEQ) is a 6-items scale that assesses the therapy credibility who refers to the extent to which a treatment makes sense, is believable, convincing and logical, and the expectancy who refers to improvements that patients believe will occur with the intervention. Two subscales are identified: the Credibility and the Expectancy. Higher scores indicate better credibility and Expectancy from the patients (better outcome).
Time Frame
Up to 72 hours after the beginning of interventions and through intervention completion (an average of 5 to 7 weeks).
Title
Therapeutic alliance
Description
The Helping Alliance Questionnaire (HAQ) is a 8-items scale that assesses client-reported quality of the therapeutic alliance. Higher score indicated higher client satisfaction in the therapeutic alliance (better outcome).
Time Frame
Up to 72 hours after the beginning of interventions and through intervention completion (an average of 5 to 7 weeks).
Title
Client Satisfaction
Description
The Consumer Satisfaction Questionnaire (CSQ) is a 8-items scale that assesses client satisfaction with treatment. Higher score indicates greater satisfaction.
Time Frame
up to 72 hours after treatment
Title
Client adherence and satisfaction
Description
This post intervention interview focused on satisfaction with the organization (i.e., size of the group, rhythm of progression, materials given, sessions' length, sessions' frequency, location, equipment), with the content (i.e., pertinence to everyday life, helpfulness of tools and compatibility with their expectations, identification, applicability, improvement, feedback) and with the therapists (i.e., motivation, communication skills, knowledge, adaptation abilities).
Time Frame
up to 72 hours after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: good understanding of French, at least a medium level of depressive symptoms report the presence of abstract rumination that generates negative mood. Exclusion Criteria: Having a history of psychotic disorder Having a history of Bipolar disorder, Having a history of severe brain trauma or epilepsy with a moderate or severe substance use disorder other than tobacco (according to the DSM-V; i.e., showing 4 or more symptoms with an organic illness (e.g. cancer), with a concurrent additional psychotherapy, with acute suicidal ideation, with evidence of a significant change in medication within one month prior to baseline assessment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie Blairy
Organizational Affiliation
University of Liege
Official's Role
Study Director
Facility Information:
Facility Name
Liège University
City
Liège
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data and analyses will be available from an online repository or from the principal investigator

Learn more about this trial

Intervention Targeting Depressive Symptoms and Mental Rumination

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