Online Cognitive Control Training for Remitted Depressed Patients

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.

Study Overview

• Status: Completed
• Conditions: Major Depression in Remission
• Intervention / Treatment: Behavioral: Cognitive control training; Behavioral: Active control training

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • Ghent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Control Training; 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; 10 sessions of an adaptive paced auditory serial addition task, each lasting 15 minutes, over the course of two weeks.
Active Comparator: Active Control Training; 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; 10 sessions of an low cognitive load task, each lasting 15 minutes, over the course of two weeks.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
User engagement	Measured by the User Engagement Scale (UES)	Assessed at post-training assessment (within 1 week of completing the training) and at 3 months follow-up
Threatening experiences	Measured by the List of Threatening Experiences (LTE)	Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Effortful control	Measured by the subscale Effortful Control (EC) from the Adult Temperament Questionnaire (ATQ)	Assessed at pre-training assessment and at 6 months follow-up
Credibility and Expectancy	Measured by the Credibility/Expectancy Questionnaire	Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Behavioral measure for cognitive control	Measured by the non-adaptive Paced Auditory Serial Addition Task (PASAT)	Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up

Collaborators and Investigators

• Sponsor: University Ghent
• Investigators: Principal Investigator: Ernst HW Koster, PhD, University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): March 13, 2019
• Study Completion (Actual): March 13, 2019

Study Registration Dates

• First Submitted: August 18, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Depression; Relapse prevention; Remission; Cognitive control training; Internet intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: B/14730/RMD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No