Online Cognitive Control Training for Remitted Depressed Patients

NCT ID: NCT03278756

Last Updated: 2022-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-03-13

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.

Conditions

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Major Depression in Remission

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Between subjects-design with two training conditions. The training condition is the only difference between the two groups during the study.
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive control training

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Active control training

Intervention Type BEHAVIORAL

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

Interventions

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Cognitive control training

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

Intervention Type BEHAVIORAL

Active control training

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ernst HW Koster, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

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Ghent University

Ghent, Oost-Vlaanderen, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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B/14730/RMD

Identifier Type: -

Identifier Source: org_study_id

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