Online Cognitive Control Training for Remitted Depressed Patients

Study Overview
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Brief Summary
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This study evaluates the effectiveness of an internet-delivered cognitive control training as a preventive intervention for remitted depressed patients. Half of the participants will receive a cognitive control training, while the other half will receive a low cognitive load training that acts as an active control condition.

Detailed Description
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Prospective studies have linked impaired cognitive control to increased cognitive vulnerability for future depression. Importantly, experimental studies indicate that cognitive control training can be used to reduce rumination and depressive symptomatology in MDD (major depressive disorder) and RMD (remitted depressed) samples. Provided that remitted depressed patients form a high-risk group for developing future depressive episodes, the current study will explore whether an internet-delivered cognitive control training can be used to reduce vulnerability for future depression in remitted depressed patients. A computer training, consisting of 10 sessions of 15 minutes each, will be administered to participants, which are remitted depressed patients. This training can either be a cognitive control training, using an adaptive paced auditory serial addition task, or an active control training, with a low cognitive load task. Dependent variables will be assessed pre- and post-training, as well as 3 and 6 months after the training, and consist of depressive symptomatology, related variables and cognitive control measures.

Official Title
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Online Cognitive Control Training for Remitted Depressed Patients

Conditions
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Major Depression in Remission

Intervention / Treatment
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* Behavioral: Cognitive control training
* Behavioral: Active control training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of ≥ 1 depressive episodes (major or bipolar) Currently in stable full or partial remission (≥ 3 months) Exclusion Criteria: Major depressive disorder (current or less than 3 months in remission) Bipolar disorder (current or less than 3 months in remission) Psychotic disorder (current and/or previous) Neurological impairments (current and/or previous) Excessive substance abuse (current and/or previous) No ongoing psychotherapeutic treatment (maintenance treatment is allowed, but with a frequency of less than once every three weeks) Use of antidepressant medication is allowed if kept at a constant level

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Between subjects-design with two training conditions. The training condition is the only difference between the two groups during the study.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Control Training<br>A cognitive control training, consisting of 10 sessions of 15 minutes each, will be administered. The task in this training is an adaptive paced auditory serial addition task, where participants need to click on the sum of the last two heard digits. | Behavioral: Cognitive control training<br>* 10 sessions of an adaptive paced auditory serial addition task, each lasting 15 minutes, over the course of two weeks.<br>|
| Active Comparator: Active Control Training<br>An active control training, consisting of 10 sessions of 15 minutes each, will be administered. The task in this training is an adaptive low load cognitive task, where participants need to click on the last heard digit. | Behavioral: Active control training<br>* 10 sessions of an low cognitive load task, each lasting 15 minutes, over the course of two weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptomatology | Measured by the Beck Depression Inventory - II (BDI-II) | Assessed at pre-training assessment and at 6 months follow-up | 
| Change in depressive symptomatology | Measured by the Depression Anxiety Stress Scales (DASS) | Assessed at pre-training assessment, at post-training assessment (within 1 week of completing the training), at 3 months follow-up and at 6 months follow-up | 
| Change in depressive rumination (brooding) | Measured by the Ruminative Response Scale (RRS), especially the brooding subscale | Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive emotion regulation strategies | Measured by the Cognitive Emotion Regulation Questionnaire (CERQ) | Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up | 
| Change in quality of life | Measured by the Quality of Life in Depression Scale (QLDS) | Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up | 
| Remission from depression | Measured by the Remission of Depression Questionnaire (RDQ) | Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up | 
| Resilience | Measured by the Connor-Davidson Resilience Scale (CD-RISC) | Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Remission, Relapse prevention, Cognitive control training, Internet intervention