Cognitive Control Training for Remitted Depressed Patients

December 16, 2015 updated by: University Ghent

Cognitive Control Training as a Preventive Intervention for Depression: A Double-blind Randomized Controlled Trial Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cognitive control training
internet-delivered, 2 weeks
Behavioral: Cognitive Control Training
10 adaptive Paced Auditory Serial Addition Task (PASAT) sessions, 400 trials each
Active Comparator: low cognitive load training
internet-delivered, 2 weeks
Behavioral: Low Cognitive Load Training
10 low cognitive load sessions, 400 trials each

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depressive rumination from baseline to the post-training assessment and follow-up (RRS)
Time Frame: baseline, 2 weeks, 3 months
Assessed using the Ruminative Response Scale (RRS)
baseline, 2 weeks, 3 months
Change in depressive symptomatology from baseline to the post-training assessment and follow-up (BDI-II)
Time Frame: baseline, 2 weeks, 3 months
Assessed using the Beck Depression Inventory (BDI-II)
baseline, 2 weeks, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(mal-)Adaptive cognitive emotion regulation (CERQ)
Time Frame: baseline, 2 weeks, 3 months
Assessed using the Cognitive Emotion Regulation Questionnaire (CERQ)
baseline, 2 weeks, 3 months
Quality of Life (QLDS)
Time Frame: baseline, 3 months
Assessed using the Quality of Life in Depression Scale (QLDS)
baseline, 3 months
Disability (WHODAS 2.0)
Time Frame: baseline, 3 months
Assessed using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
baseline, 3 months
Resilience (RS)
Time Frame: baseline, 3 months
Assessed using the Resilience Scale (RS)
baseline, 3 months
Remission from depression (RDQ)
Time Frame: baseline, 3 months
Assessed using the Remission of Depression Questionnaire (RDQ)
baseline, 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral measure for cognitive control ((non-adaptive) PASAT)
Time Frame: baseline, 2 weeks, 3 months
Assessed using the (non-adaptive) PASAT
baseline, 2 weeks, 3 months
Self-reported cognitive control (BRIEF-A)
Time Frame: baseline, 2 weeks, 3 months
Assessed using the Behaviour Rating Inventory of Executive Function Adult Version (BRIEF-A)
baseline, 2 weeks, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

April 2, 2015

First Posted (Estimate)

April 3, 2015

Study Record Updates

Last Update Posted (Estimate)

December 17, 2015

Last Update Submitted That Met QC Criteria

December 16, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B/13808/01-CCT-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Major Depression in Remission

Clinical Trials on Cognitive Control Training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe