Online Cognitive Control Training for Remitted Depressed Patients

NCT03278756 | Completed

• 1 other identifier: B/14730/RMD
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression in Remission

Keywords

Depression; Remission; Relapse prevention; Cognitive control training; Internet intervention

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change in cognitive emotion regulation strategies

  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

  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

  Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up

• Resilience

  Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up

Other Outcomes (5)

• User engagement

  Assessed at post-training assessment (within 1 week of completing the training) and at 3 months follow-up

• Threatening experiences

  Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up

• Effortful control

  Assessed at pre-training assessment and at 6 months follow-up

Study Arms (2)

Cognitive Control Training

EXPERIMENTAL

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

Active Control Training

ACTIVE COMPARATOR

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

Interventions

Cognitive control training BEHAVIORAL

10 sessions of an adaptive paced auditory serial addition task, each lasting 15 minutes, over the course of two weeks.

Cognitive Control Training

Active control training BEHAVIORAL

10 sessions of an low cognitive load task, each lasting 15 minutes, over the course of two weeks.

Active Control Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of ≥ 1 depressive episodes (major or bipolar)
• Currently in stable full or partial remission (≥ 3 months)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Ernst HW Koster, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Between subjects-design with two training conditions. The training condition is the only difference between the two groups during the study.

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: September 12, 2017
• Study Start: September 1, 2017
• Primary Completion: March 13, 2019
• Study Completion: March 13, 2019
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

BE (1)