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Intervention Targeting Motivational Negative Symptoms (Switch)

Primary Purpose

Schizophrenia, Schizo Affective Disorder, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Switch - Individual sessions
Switch - Group programme
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnostic and Statistical Manual-V (DSM-V) criteria for schizophrenia, schizoaffective, bipolar or major depressive disorder (American Psychiatric Association, 2013).
  • Good understanding of French.

Exclusion Criteria:

  • Presenting an unstable clinical picture;
  • Evidence of a significant change in medication within one month prior to baseline assessment;
  • Having a history of severe brain trauma or epilepsy;
  • Comorbid intellectual disability;
  • Moderate or severe substance use disorder other than tobacco (according to the DSM-V; i.e., showing 4 or more symptoms).

Sites / Locations

  • University of Liege

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Switch - i

Switch - g

Arm Description

Individual sessions

Group programme

Outcomes

Primary Outcome Measures

Brief Negative Symptom Scale (BNSS)
There are 13 items that are scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe). The Expressive deficit factor includes the following subscales: Blunted affect (facial expression, vocal expression, expressive gestures) and Alogia (quantity of speech, spontaneous elaboration).Each item is scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe).
Brief Negative Symptom Scale (BNSS)
There are 13 items that are scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe). The Expressive deficit factor includes the following subscales: Blunted affect (facial expression, vocal expression, expressive gestures) and Alogia (quantity of speech, spontaneous elaboration).Each item is scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe).
Brief Negative Symptom Scale (BNSS)
There are 13 items that are scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe). The Expressive deficit factor includes the following subscales: Blunted affect (facial expression, vocal expression, expressive gestures) and Alogia (quantity of speech, spontaneous elaboration).Each item is scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe).
Lille Apathy Rating Scale (patient version) (LARS-p)
The LARS is a semi-structured interview designed to evaluate the different dimensions (cognitive, emotional and behavioural) of apathy in schizophrenia, through the following subscales: Everyday productivity, Interests, Taking initiatives, Novelty seeking, Voluntary actions, Emotional responses, Concern, Social life and Self-awareness. The total score ranges from -36 to 36 ([-36; -22] = absence of apathy; [-21; -17] = tendency towards apathy; [-16; -10] = moderate apathy; [-9; 36] = severe apathy).
Lille Apathy Rating Scale (patient version) (LARS-p)
The LARS is a semi-structured interview designed to evaluate the different dimensions (cognitive, emotional and behavioural) of apathy in schizophrenia, through the following subscales: Everyday productivity, Interests, Taking initiatives, Novelty seeking, Voluntary actions, Emotional responses, Concern, Social life and Self-awareness. The total score ranges from -36 to 36 ([-36; -22] = absence of apathy; [-21; -17] = tendency towards apathy; [-16; -10] = moderate apathy; [-9; 36] = severe apathy).
Lille Apathy Rating Scale (informant version) (LARS-i)
The LARS is a semi-structured interview designed to evaluate the different dimensions (cognitive, emotional and behavioural) of apathy in schizophrenia, through the following subscales: Everyday productivity, Interests, Taking initiatives, Novelty seeking, Voluntary actions, Emotional responses, Concern, Social life and Self-awareness. The total score ranges from -36 to 36 ([-36; -22] = absence of apathy; [-21; -17] = tendency towards apathy; [-16; -10] = moderate apathy; [-9; 36] = severe apathy).
Schizophrenia - Quality of Life questionnaire
The S-QoL is a 41-item questionnaire that evaluates life satisfaction regarding psychological wellbeing, self-esteem, family relationships, relationships with friends, resilience, physical wellbeing, autonomy and sentimental life. Items are rated on a 5-point Likert scale (1 = much less satisfied than expected; 2 = less satisfied; 3 = slightly less satisfied; 4 = as satisfied; 5 = more satisfied). The total score ranges from 0 to 100, higher scores indicating better subjective quality of life.
Schizophrenia - Quality of Life questionnaire
The S-QoL is a 41-item questionnaire that evaluates life satisfaction regarding psychological wellbeing, self-esteem, family relationships, relationships with friends, resilience, physical wellbeing, autonomy and sentimental life. Items are rated on a 5-point Likert scale (1 = much less satisfied than expected; 2 = less satisfied; 3 = slightly less satisfied; 4 = as satisfied; 5 = more satisfied). The total score ranges from 0 to 100, higher scores indicating better subjective quality of life.
Schizophrenia - Quality of Life questionnaire
The S-QoL is a 41-item questionnaire that evaluates life satisfaction regarding psychological wellbeing, self-esteem, family relationships, relationships with friends, resilience, physical wellbeing, autonomy and sentimental life. Items are rated on a 5-point Likert scale (1 = much less satisfied than expected; 2 = less satisfied; 3 = slightly less satisfied; 4 = as satisfied; 5 = more satisfied). The total score ranges from 0 to 100, higher scores indicating better subjective quality of life.
Functional Remission of General Schizophrenia (FROGS)
The FROGS is a measure of daily life outcomes, which evaluates level of functioning in 5 different domains: Daily life, Activities, Relationships, Quality of adaptation, and Health and treatment. The total score ranges from 19 to 95. The threshold score for remission is 61.
Functional Remission of General Schizophrenia (FROGS)
The FROGS is a measure of daily life outcomes, which evaluates level of functioning in 5 different domains: Daily life, Activities, Relationships, Quality of adaptation, and Health and treatment. The total score ranges from 19 to 95. The threshold score for remission is 61.
Functional Remission of General Schizophrenia (FROGS)
The FROGS is a measure of daily life outcomes, which evaluates level of functioning in 5 different domains: Daily life, Activities, Relationships, Quality of adaptation, and Health and treatment. The total score ranges from 19 to 95. The threshold score for remission is 61.

Secondary Outcome Measures

Experience Sampling Method
Questionnaire including 14 questions regarding mood, discouraging beliefs, coping, confidence, motivation, energy, social environment, current activity, initiation, present enjoyment, activity's meaning, effort, reminiscence, projection into the future. The questionnaires are sent 3 times (intervention phase) or 5 times per day (baseline, post-intervention and follow-up phases).
Experience Sampling Method
Questionnaire including 14 questions regarding mood, discouraging beliefs, coping, confidence, motivation, energy, social environment, current activity, initiation, present enjoyment, activity's meaning, effort, reminiscence, projection into the future. The questionnaires are sent 3 times (intervention phase) or 5 times per day (baseline, post-intervention and follow-up phases).
Experience Sampling Method
Questionnaire including 14 questions regarding mood, discouraging beliefs, coping, confidence, motivation, energy, social environment, current activity, initiation, present enjoyment, activity's meaning, effort, reminiscence, projection into the future. The questionnaires are sent 3 times (intervention phase) or 5 times per day (baseline, post-intervention and follow-up phases).
Experience Sampling Method
Questionnaire including 14 questions regarding mood, discouraging beliefs, coping, confidence, motivation, energy, social environment, current activity, initiation, present enjoyment, activity's meaning, effort, reminiscence, projection into the future. The questionnaires are sent 3 times (intervention phase) or 5 times per day (baseline, post-intervention and follow-up phases).
Step count
Daily step count (total per day) via an activity band.
Step count
Daily step count (total per day) via an activity band.
Step count
Daily step count (total per day) via an activity band.
Step count
Daily step count (total per day) via an activity band.

Full Information

First Posted
March 19, 2020
Last Updated
March 25, 2020
Sponsor
University of Liege
Collaborators
Fonds National de la Recherche Scientifique
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1. Study Identification

Unique Protocol Identification Number
NCT04325100
Brief Title
Intervention Targeting Motivational Negative Symptoms
Acronym
Switch
Official Title
Development and Validation of an Intervention Targeting Motivational Negative Symptoms: Switch Protocol 2
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 20, 2019 (Actual)
Primary Completion Date
December 6, 2019 (Actual)
Study Completion Date
February 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
Collaborators
Fonds National de la Recherche Scientifique

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 effects of the Switch intervention on motivation and associated processes and explore the dynamics between the processes. A single case approach is followed, with a pre-post and follow-up assessment design, and continuous ambulatory assessments (experience sampling method (ESM) and step count).
Detailed Description
Motivational negative symptoms hinder quality of life and daily functioning of individuals with schizophrenia spectrum, bipolar and major depressive disorders. A recently developed intervention, Switch, has shown promising effects on negative symptoms and functional outcomes. Switch is based on a model that identifies various cognitive, behavioural and emotional processes related to motivation and goal-directed behaviours: pleasure anticipation, value-effort-probability computation, (dys)functional attitudes (e.g., discouraging thoughts, self-efficacy), planning, initiation, in-the-moment enjoyment, reminiscence. The intervention combines a person-centred and recovery approach with cognitive, behavioural and 3rd wave techniques to tackle the obstacles related to motivation and goal-directed behaviours (i.e., targetting the various cognitive, behavioural and emotional processes listed above). Thus, an important part of the intervention focuses on the person's strengths, needs, goals and values. Furthermore, various strategies (e.g., cognitive defusion, pleasure anticipation, problem solving, reminiscence) are used to encourage engagement in meaningful personal goals and values. The Switch intervention is provided either in individual (one-hour sessions), or in a group setting (two-hour sessions), twice a week for around two months. There are three types of evaluation: traditional assessment scales of motivational deficits, apathy, quality of life and daily functioning (pre, post and follow-up at 3 months); ambulatory assessment including ESM (i.e., daily questionnaires); actigraphy (step count). The aims of this study is to evaluate the efficacy of Switch in two different settings (i.e., individual sessions and a group programme) on motivation/apathy and functional outcomes/quality of life. Furthermore, we wish to explore the effects of Switch on process related to motivation and goal-directed behaviours (e.g., pleasure anticipation, reminiscence, defeatist beliefs, activities' meaningfulness) and on activity (i.e., step count). Finally, we wish to evaluate the dynamics between the different cognitive, behavioural and emotional processes related to motivation and goal-directed behaviours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizo Affective Disorder, Bipolar Disorder, Major Depressive Disorder

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 evaluation of the Brief Negative Symptom Scale: 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
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Switch - i
Arm Type
Experimental
Arm Description
Individual sessions
Arm Title
Switch - g
Arm Type
Experimental
Arm Description
Group programme
Intervention Type
Behavioral
Intervention Name(s)
Switch - Individual sessions
Intervention Description
Participants follow the Switch intervention through individual sessions (1 hour, twice a week, for around 2 months). Participants are provided with a folder which presents the rational for each strategy. Take-home assignments are given and stored in the same folder. Participants are also given small cards (that can fit in their wallet) containing the key elements of each strategy. The intervention manual can be obtained from the main investigator (in French).
Intervention Type
Behavioral
Intervention Name(s)
Switch - Group programme
Intervention Description
Participants follow the Switch group programme (2 hours, twice a week, for around 2 months). During the group sessions, a powerpoint presentation and different media are used to present the different parts of the motivation model. Participants learn the different strategies (e.g., cognitive defusion, pleasure anticipation, problem solving) through individual and group exercises. Participants are provided with a folder which presents the rational for each strategy. Take-home assignments are given and stored in the same folder. Participants are also given small cards (that can fit in their wallet) containing the key elements of each strategy. The intervention manual and the presentation material can be obtained from the main investigator (in French).
Primary Outcome Measure Information:
Title
Brief Negative Symptom Scale (BNSS)
Description
There are 13 items that are scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe). The Expressive deficit factor includes the following subscales: Blunted affect (facial expression, vocal expression, expressive gestures) and Alogia (quantity of speech, spontaneous elaboration).Each item is scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe).
Time Frame
Baseline
Title
Brief Negative Symptom Scale (BNSS)
Description
There are 13 items that are scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe). The Expressive deficit factor includes the following subscales: Blunted affect (facial expression, vocal expression, expressive gestures) and Alogia (quantity of speech, spontaneous elaboration).Each item is scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe).
Time Frame
2 months (post intervention)
Title
Brief Negative Symptom Scale (BNSS)
Description
There are 13 items that are scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe). The Expressive deficit factor includes the following subscales: Blunted affect (facial expression, vocal expression, expressive gestures) and Alogia (quantity of speech, spontaneous elaboration).Each item is scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe).
Time Frame
6 months (follow-up)
Title
Lille Apathy Rating Scale (patient version) (LARS-p)
Description
The LARS is a semi-structured interview designed to evaluate the different dimensions (cognitive, emotional and behavioural) of apathy in schizophrenia, through the following subscales: Everyday productivity, Interests, Taking initiatives, Novelty seeking, Voluntary actions, Emotional responses, Concern, Social life and Self-awareness. The total score ranges from -36 to 36 ([-36; -22] = absence of apathy; [-21; -17] = tendency towards apathy; [-16; -10] = moderate apathy; [-9; 36] = severe apathy).
Time Frame
Baseline
Title
Lille Apathy Rating Scale (patient version) (LARS-p)
Description
The LARS is a semi-structured interview designed to evaluate the different dimensions (cognitive, emotional and behavioural) of apathy in schizophrenia, through the following subscales: Everyday productivity, Interests, Taking initiatives, Novelty seeking, Voluntary actions, Emotional responses, Concern, Social life and Self-awareness. The total score ranges from -36 to 36 ([-36; -22] = absence of apathy; [-21; -17] = tendency towards apathy; [-16; -10] = moderate apathy; [-9; 36] = severe apathy).
Time Frame
2 months (post-intervention)
Title
Lille Apathy Rating Scale (informant version) (LARS-i)
Description
The LARS is a semi-structured interview designed to evaluate the different dimensions (cognitive, emotional and behavioural) of apathy in schizophrenia, through the following subscales: Everyday productivity, Interests, Taking initiatives, Novelty seeking, Voluntary actions, Emotional responses, Concern, Social life and Self-awareness. The total score ranges from -36 to 36 ([-36; -22] = absence of apathy; [-21; -17] = tendency towards apathy; [-16; -10] = moderate apathy; [-9; 36] = severe apathy).
Time Frame
6 months (follow-up)
Title
Schizophrenia - Quality of Life questionnaire
Description
The S-QoL is a 41-item questionnaire that evaluates life satisfaction regarding psychological wellbeing, self-esteem, family relationships, relationships with friends, resilience, physical wellbeing, autonomy and sentimental life. Items are rated on a 5-point Likert scale (1 = much less satisfied than expected; 2 = less satisfied; 3 = slightly less satisfied; 4 = as satisfied; 5 = more satisfied). The total score ranges from 0 to 100, higher scores indicating better subjective quality of life.
Time Frame
Baseline (month 0)
Title
Schizophrenia - Quality of Life questionnaire
Description
The S-QoL is a 41-item questionnaire that evaluates life satisfaction regarding psychological wellbeing, self-esteem, family relationships, relationships with friends, resilience, physical wellbeing, autonomy and sentimental life. Items are rated on a 5-point Likert scale (1 = much less satisfied than expected; 2 = less satisfied; 3 = slightly less satisfied; 4 = as satisfied; 5 = more satisfied). The total score ranges from 0 to 100, higher scores indicating better subjective quality of life.
Time Frame
2 months (post-intervention)
Title
Schizophrenia - Quality of Life questionnaire
Description
The S-QoL is a 41-item questionnaire that evaluates life satisfaction regarding psychological wellbeing, self-esteem, family relationships, relationships with friends, resilience, physical wellbeing, autonomy and sentimental life. Items are rated on a 5-point Likert scale (1 = much less satisfied than expected; 2 = less satisfied; 3 = slightly less satisfied; 4 = as satisfied; 5 = more satisfied). The total score ranges from 0 to 100, higher scores indicating better subjective quality of life.
Time Frame
6 months (follow-up)
Title
Functional Remission of General Schizophrenia (FROGS)
Description
The FROGS is a measure of daily life outcomes, which evaluates level of functioning in 5 different domains: Daily life, Activities, Relationships, Quality of adaptation, and Health and treatment. The total score ranges from 19 to 95. The threshold score for remission is 61.
Time Frame
Baseline
Title
Functional Remission of General Schizophrenia (FROGS)
Description
The FROGS is a measure of daily life outcomes, which evaluates level of functioning in 5 different domains: Daily life, Activities, Relationships, Quality of adaptation, and Health and treatment. The total score ranges from 19 to 95. The threshold score for remission is 61.
Time Frame
2 months (post-intervention)
Title
Functional Remission of General Schizophrenia (FROGS)
Description
The FROGS is a measure of daily life outcomes, which evaluates level of functioning in 5 different domains: Daily life, Activities, Relationships, Quality of adaptation, and Health and treatment. The total score ranges from 19 to 95. The threshold score for remission is 61.
Time Frame
6 months (follow-up)
Secondary Outcome Measure Information:
Title
Experience Sampling Method
Description
Questionnaire including 14 questions regarding mood, discouraging beliefs, coping, confidence, motivation, energy, social environment, current activity, initiation, present enjoyment, activity's meaning, effort, reminiscence, projection into the future. The questionnaires are sent 3 times (intervention phase) or 5 times per day (baseline, post-intervention and follow-up phases).
Time Frame
Baseline (14 days): 5 triggers/day
Title
Experience Sampling Method
Description
Questionnaire including 14 questions regarding mood, discouraging beliefs, coping, confidence, motivation, energy, social environment, current activity, initiation, present enjoyment, activity's meaning, effort, reminiscence, projection into the future. The questionnaires are sent 3 times (intervention phase) or 5 times per day (baseline, post-intervention and follow-up phases).
Time Frame
Intervention phase (60 days): 3 triggers/day
Title
Experience Sampling Method
Description
Questionnaire including 14 questions regarding mood, discouraging beliefs, coping, confidence, motivation, energy, social environment, current activity, initiation, present enjoyment, activity's meaning, effort, reminiscence, projection into the future. The questionnaires are sent 3 times (intervention phase) or 5 times per day (baseline, post-intervention and follow-up phases).
Time Frame
Post-intervention (14 days): 5 triggers/day
Title
Experience Sampling Method
Description
Questionnaire including 14 questions regarding mood, discouraging beliefs, coping, confidence, motivation, energy, social environment, current activity, initiation, present enjoyment, activity's meaning, effort, reminiscence, projection into the future. The questionnaires are sent 3 times (intervention phase) or 5 times per day (baseline, post-intervention and follow-up phases).
Time Frame
Follow-up (14 days): 5 triggers/day
Title
Step count
Description
Daily step count (total per day) via an activity band.
Time Frame
Baseline (14 days): 5 triggers/day
Title
Step count
Description
Daily step count (total per day) via an activity band.
Time Frame
Intervention phase (60 days): 3 triggers/day
Title
Step count
Description
Daily step count (total per day) via an activity band.
Time Frame
Post-intervention (14 days): 5 triggers/day
Title
Step count
Description
Daily step count (total per day) via an activity band.
Time Frame
Follow-up (14 days): 5 triggers/day

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: Diagnostic and Statistical Manual-V (DSM-V) criteria for schizophrenia, schizoaffective, bipolar or major depressive disorder (American Psychiatric Association, 2013). Good understanding of French. Exclusion Criteria: Presenting an unstable clinical picture; Evidence of a significant change in medication within one month prior to baseline assessment; Having a history of severe brain trauma or epilepsy; Comorbid intellectual disability; Moderate or severe substance use disorder other than tobacco (according to the DSM-V; i.e., showing 4 or more symptoms).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Laroi, PhD
Organizational Affiliation
University of Liege
Official's Role
Study Director
Facility Information:
Facility Name
University of Liege
City
Liège
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data and analyses will be available from an online repository or from the principal investigator.
Citations:
PubMed Identifier
32977798
Citation
Thonon B, Van Aubel E, Lafit G, Della Libera C, Laroi F. Idiographic analyses of motivation and related processes in participants with schizophrenia following a therapeutic intervention for negative symptoms. BMC Psychiatry. 2020 Sep 25;20(1):464. doi: 10.1186/s12888-020-02824-5.
Results Reference
derived

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Intervention Targeting Motivational Negative Symptoms

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