Clinical trial NCT02407652: Cognitive Control Training for Remitted Depressed Patients
Official title: Cognitive Control Training as a Preventive Intervention for Depression: A Double-blind Randomized Controlled Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression in Remission
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 68
Sex: ALL
Minimum age (years): 23
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to explore the effectiveness of an internet-delivered cognitive control training as a preventive intervention for remitted depressed patients.

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 samples. Furthermore, studies exploring the potential of cognitive control training in at-risk undergraduate students indicate that cognitive control training has beneficial effects on rumination, an important vulnerability factor for depression. Provided that remitted depressed patients form a high-risk group for developing future depressive episodes, the current study will explore whether internet-delivered cognitive control training can be used to reduce vulnerability for future depression in remitted depressed patients. The investigators will explore effects on depressive symptomatology, (mal-)adaptive emotion regulation (directly following training and at 3 months follow-up), and indices of functioning (at 3 months follow-up).

Eligibility criteria: Inclusion Criteria:

* History of ≥ 1 depressive episode(s)
* Currently in stable full or partial remission (≥ 6 months)

Exclusion Criteria:

* Major depressive disorder (MDD; current)
* Bipolar disorder (current and/or previous)
* Psychotic disorder (current and/or previous)
* Neurological impairments (current and/or previous)
* Excessive substance abuse (current and/or previous)
* No other comorbid disorders (current)
* No ongoing psychotherapeutic treatment (maintenance treatment is allowed, but with a frequency less than once / 3 weeks)
* Use of antidepressant medication is allowed if kept at a constant level

Primary outcomes:
measure: Change in depressive rumination from baseline to the post-training assessment and follow-up (RRS)
timeFrame: baseline, 2 weeks, 3 months
measure: Change in depressive symptomatology from baseline to the post-training assessment and follow-up (BDI-II)
timeFrame: baseline, 2 weeks, 3 months
Secondary outcomes:
measure: (mal-)Adaptive cognitive emotion regulation (CERQ)
timeFrame: baseline, 2 weeks, 3 months
measure: Quality of Life (QLDS)
timeFrame: baseline, 3 months
measure: Disability (WHODAS 2.0)
timeFrame: baseline, 3 months
measure: Resilience (RS)
timeFrame: baseline, 3 months
measure: Remission from depression (RDQ)
timeFrame: baseline, 3 months
Other outcomes:
measure: Behavioral measure for cognitive control ((non-adaptive) PASAT)
timeFrame: baseline, 2 weeks, 3 months
measure: Self-reported cognitive control (BRIEF-A)
timeFrame: baseline, 2 weeks, 3 months
Locations:
city: Ghent
country: Belgium
facility: Ghent University
state: Oost-Vlaanderen
Study officials:
affiliation: University Ghent
name: Ernst Koster, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoorelbeke K, Koster EHW. Internet-delivered cognitive control training as a preventive intervention for remitted depressed patients: Evidence from a double-blind randomized controlled trial study. J Consult Clin Psychol. 2017 Feb;85(2):135-146. doi: 10.1037/ccp0000128. Epub 2016 Jun 30.
citation: Hoorelbeke K, Faelens L, Behiels J, Koster EH. Internet-delivered cognitive control training as a preventive intervention for remitted depressed patients: Protocol for a randomized controlled trial. BMC Psychiatry. 2015 Jun 9;15:125. doi: 10.1186/s12888-015-0511-0.