Effects of Booster Sessions on Depression Vulnerability Following Cognitive Control Training
Primary Purpose
Major Depression in Remission
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cognitive Control Training (CCT)
Cognitive Control Training (CCT) + Booster Sessions
Sponsored by
About this trial
This is an interventional prevention trial for Major Depression in Remission focused on measuring Depression, Remission, Relapse Prevention, Cognitive Control Training, Internet Intervention
Eligibility Criteria
Inclusion Criteria:
- History of ≥ 1 depressive episode(s)
- Currently in remission (≥ 3 months)
- Access to a computer with an internet connection
- Access to a smartphone
Exclusion Criteria:
- Ongoing depressive episode
- Psychotic disorder (current and/or previous)
- Neurological impairments (current and/or previous)
- Excessive substance abuse (current and/or previous)
- Use of antidepressant medication is allowed if kept at a constant level
Sites / Locations
- Ghent University Hospital
- Ghent UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cognitive Control Training Group
Cognitive Control Training + Booster Sessions Group
Arm Description
Outcomes
Primary Outcome Measures
Change in Patient Health Questionnaire (PHQ-9)
Self-report questionnaire measuring depression symptomatology, with higher scores indicating more severe depression symptoms.
Secondary Outcome Measures
Change in Beck Depression Inventory (BDI-II-NL)
Self-report questionnaire measuring depression symptomatology, with higher scores indicating more severe depression symptoms.
Change in Perseverative Thinking Questionnaire (PTQ-NL)
Change from baseline in repetitive negative thinking. The PTQ-NL consist of 15 items which are rated from 0 (never) to 4 (almost always). Lower scores indicate lower levels of repetitive negative thinking.
Change in Cognitive Emotion Regulation Questionnaire (CERQ)
Self-report measure for emotion regulation: a 36-item questionnaire, consisting of adaptive and maladaptive emotion regulation strategies. Each item is rated on a 1 to 5 scale (1 = almost never and 5 = almost always).
Change in Adult Temperament Questionnaire (ATQ), Effortful Control subscale
Measured by the subscale Effortful Control (EC) from the Adult Temperament Questionnaire (ATQ).
Change in Burnout Assessment Tool (BAT)
The Burnout Assessment Tool (BAT) is used to assess burn-out risk. The score ranges from 1 to 5, with higher scores indicating a higher risk of burn-out
Change in Remission from Depression Questionnaire (RDQ-NL)
The Remission from Depression Questionnaire has 41 items, which assess domains such as positive mental health, life satisfaction, and sense of well-being. The items are scored 0 (not at all or rarely true), 1 (sometimes true) or 2 (often or almost always true).
Change in non-adaptive PASAT performance
A non-adaptive computerized version of the Paced Auditory Serial- Addition Task (PASAT) was used as a measure of participants' working memory abilities. Higher accuracy scores suggest greater cognitive control resources.
Change in Work Productivity and Activity Impairment Questionnaire (WPAI)
The 6-item WPAI measures the effect of health problems on the ability to work and carry out daily activities.
Change in Short Form Health Survey (SF-36)
The 11-item SF-36 measures attitudes on general health.
Change in questionnaire based on the Medical Consumption Questionnaire (iMCQ)
The iMCQ measures healthcare consumption.
Full Information
NCT ID
NCT05557760
First Posted
September 21, 2022
Last Updated
November 7, 2022
Sponsor
University Ghent
Collaborators
University Hospital, Ghent, Research Foundation Flanders
1. Study Identification
Unique Protocol Identification Number
NCT05557760
Brief Title
Effects of Booster Sessions on Depression Vulnerability Following Cognitive Control Training
Official Title
Evaluating the Effects of Personalized Booster Sessions on Depression Vulnerability Following Cognitive Control Training for Remitted Depressed Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
University Hospital, Ghent, Research Foundation Flanders
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
The current study aims to examine the impact of booster sessions of cognitive control training (CCT) on indicators of depression vulnerability. Remitted depressed individuals (RMD) will be randomized over two groups, each receiving 10 sessions of the adaptive Paced Auditory Serial Addition Task, a well-established CCT procedure (Koster et al., 2017; Siegle et al., 2007). During and following completion of the training procedure, functioning will be monitored on a weekly basis over a period of 15 weeks. During this period, one group will be offered booster sessions based on early warning signs for possible recurrence of depression, whilst the other group will not receive booster sessions.
Detailed Description
Cognitive impairments are closely associated with depression and recent studies have found that these cognitive problems can persist following remission of depression. Internet-delivered cognitive control training (CCT), and the adaptive Paced Auditory Serial Addition Task (aPASAT) in particular, has shown to be an effective preventative intervention for remitted depressed individuals (RMD), where beneficial effects have been found for rumination, depressive symptomatology (Hoorelbeke & Koster, 2017), and risk for recurrence of depression (Hoorelbeke et al., 2021). At the same time, prior studies suggest significant heterogeneity in response to CCT, where RMD individuals can show strong fluctuations in functioning in the months following completion of aPASAT training. In line with this, recent findings suggest that, for individuals with high-risk profiles, initial training gains may diminish over time, resulting in recurrence of internalizing symptomatology (Hoorelbeke et al., 2022). As such, there may be merit in the use of CCT booster sessions.
Currently, it is unclear whether offering additional CCT sessions when RMD individuals are reporting increased symptomatology (i.e., adding booster sessions based on early warning signs for possible recurrence of depression) can increase the long-term effectiveness of CCT. In this study, two groups of RMD individuals will perform 10 CCT sessions, after which one group will be offered booster sessions (contingent on indicators of functioning). For this purpose, we will rely on 15 weekly mobile assessments, using the PHQ-9 questionnaire. In addition, functioning will be assessed using a more extensive assessment battery at baseline, post-training (2 weeks after baseline) and follow-up (15 weeks after baseline).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression in Remission
Keywords
Depression, Remission, Relapse Prevention, Cognitive Control Training, Internet Intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Control Training Group
Arm Type
Experimental
Arm Title
Cognitive Control Training + Booster Sessions Group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Control Training (CCT)
Intervention Description
The CCT training group without booster sessions will receive 10 training sessions with the Adaptive Paced Auditory Serial Addition Task (aPASAT). The aPASAT is a Cognitive Control Training where participants need to click on the sum of the last two heard digits.
Task difficulty is modified based on the participants' current task performance, allowing training of cognitive control.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Control Training (CCT) + Booster Sessions
Intervention Description
The CCT with booster sessions group will receive 10 training sessions with the Adaptive Paced Auditory Serial Addition Task (aPASAT). After these training sessions, participants in this condition will be asked to complete additional CCT sessions after reporting two consecutive assessments of increased depressive symptoms during the monitoring period (PHQ-9 scores equal or greater to 9). Specifically, they will then be instructed to perform three additional sessions within one week. This may be repeated when the participant reports multiple consecutive assessments of increased depressive symptoms during the post-training phase, with a minimum of 3 weeks between the booster sessions and a maximum of 9 boosters (3 x 3 sessions) in total.
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire (PHQ-9)
Description
Self-report questionnaire measuring depression symptomatology, with higher scores indicating more severe depression symptoms.
Time Frame
weekly assessments from baseline until follow-up (15 weeks after baseline)
Secondary Outcome Measure Information:
Title
Change in Beck Depression Inventory (BDI-II-NL)
Description
Self-report questionnaire measuring depression symptomatology, with higher scores indicating more severe depression symptoms.
Time Frame
baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
Title
Change in Perseverative Thinking Questionnaire (PTQ-NL)
Description
Change from baseline in repetitive negative thinking. The PTQ-NL consist of 15 items which are rated from 0 (never) to 4 (almost always). Lower scores indicate lower levels of repetitive negative thinking.
Time Frame
baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
Title
Change in Cognitive Emotion Regulation Questionnaire (CERQ)
Description
Self-report measure for emotion regulation: a 36-item questionnaire, consisting of adaptive and maladaptive emotion regulation strategies. Each item is rated on a 1 to 5 scale (1 = almost never and 5 = almost always).
Time Frame
baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
Title
Change in Adult Temperament Questionnaire (ATQ), Effortful Control subscale
Description
Measured by the subscale Effortful Control (EC) from the Adult Temperament Questionnaire (ATQ).
Time Frame
baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
Title
Change in Burnout Assessment Tool (BAT)
Description
The Burnout Assessment Tool (BAT) is used to assess burn-out risk. The score ranges from 1 to 5, with higher scores indicating a higher risk of burn-out
Time Frame
baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
Title
Change in Remission from Depression Questionnaire (RDQ-NL)
Description
The Remission from Depression Questionnaire has 41 items, which assess domains such as positive mental health, life satisfaction, and sense of well-being. The items are scored 0 (not at all or rarely true), 1 (sometimes true) or 2 (often or almost always true).
Time Frame
baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
Title
Change in non-adaptive PASAT performance
Description
A non-adaptive computerized version of the Paced Auditory Serial- Addition Task (PASAT) was used as a measure of participants' working memory abilities. Higher accuracy scores suggest greater cognitive control resources.
Time Frame
baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
Title
Change in Work Productivity and Activity Impairment Questionnaire (WPAI)
Description
The 6-item WPAI measures the effect of health problems on the ability to work and carry out daily activities.
Time Frame
baseline, follow-up (15 weeks after baseline)
Title
Change in Short Form Health Survey (SF-36)
Description
The 11-item SF-36 measures attitudes on general health.
Time Frame
baseline, follow-up (15 weeks after baseline)
Title
Change in questionnaire based on the Medical Consumption Questionnaire (iMCQ)
Description
The iMCQ measures healthcare consumption.
Time Frame
baseline, follow-up (15 weeks after baseline)
Other Pre-specified Outcome Measures:
Title
Change in List of Threatening Experiences (LTE-Q)
Description
In the LTE questionnaire, unpleasant life events are listed and participants are asked if these events occurred recently. The LTE-Q contains 13 items for which "yes" or "no" are the two possible answers. This questionnaire is included to be able to check for occurrence of life events during the intervention- and follow-up period.
Time Frame
baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
History of ≥ 1 depressive episode(s)
Currently in remission (≥ 3 months)
Access to a computer with an internet connection
Access to a smartphone
Exclusion Criteria:
Ongoing depressive episode
Psychotic disorder (current and/or previous)
Neurological impairments (current and/or previous)
Excessive substance abuse (current and/or previous)
Use of antidepressant medication is allowed if kept at a constant level
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ernst Koster, PhD
Phone
+ 32 9 2646446
Email
Ernst.Koster@ugent.be
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Baeken, PhD
First Name & Middle Initial & Last Name & Degree
Chris Baeken, PhD
First Name & Middle Initial & Last Name & Degree
Nick Verhaeghe, PhD
First Name & Middle Initial & Last Name & Degree
Constance Nève de Mévergnies, MSc
Facility Name
Ghent University
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ernst Koster, PhD
First Name & Middle Initial & Last Name & Degree
Ernst HW Koster, PhD
First Name & Middle Initial & Last Name & Degree
Kristof Hoorelbeke, PhD
First Name & Middle Initial & Last Name & Degree
Yannick Vander Zwalmen, MSc
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Pseudonymized individual participant data can be stored on Open-Science Framework (OSF).
Learn more about this trial
Effects of Booster Sessions on Depression Vulnerability Following Cognitive Control Training
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