Clinical trial NCT03278756: Online Cognitive Control Training for Remitted Depressed Patients
Official title: Online Cognitive Control Training for Remitted Depressed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression in Remission
Keywords: Depression
Remission
Relapse prevention
Cognitive control training
Internet intervention
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Between subjects-design with two training conditions. The training condition is the only difference between the two groups during the study.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in depressive symptomatology
timeFrame: Assessed at pre-training assessment and at 6 months follow-up
measure: Change in depressive symptomatology
timeFrame: 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
measure: Change in depressive rumination (brooding)
timeFrame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Secondary outcomes:
measure: Change in cognitive emotion regulation strategies
timeFrame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
measure: Change in quality of life
timeFrame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
measure: Remission from depression
timeFrame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
measure: Resilience
timeFrame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Other outcomes:
measure: User engagement
timeFrame: Assessed at post-training assessment (within 1 week of completing the training) and at 3 months follow-up
measure: Threatening experiences
timeFrame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
measure: Effortful control
timeFrame: Assessed at pre-training assessment and at 6 months follow-up
measure: Credibility and Expectancy
timeFrame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
measure: Behavioral measure for cognitive control
timeFrame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Locations:
city: Gent
country: Belgium
facility: Ghent University
state: Oost-Vlaanderen
Study officials:
affiliation: University Ghent
name: Ernst HW Koster, PhD
role: PRINCIPAL_INVESTIGATOR
References: