Back to results

Online Cognitive Control Training for Remitted Depressed Patients

Primary Purpose

Major Depression in Remission

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Cognitive control training

Active control training

About this trial

This is an interventional prevention trial for Major Depression in Remission focused on measuring Depression, Remission, Relapse prevention, Cognitive control training, Internet intervention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Ghent University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Control Training

Active Control Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in depressive symptomatology

Measured by the Beck Depression Inventory - II (BDI-II)

Change in depressive symptomatology

Measured by the Depression Anxiety Stress Scales (DASS)

Change in depressive rumination (brooding)

Measured by the Ruminative Response Scale (RRS), especially the brooding subscale

Secondary Outcome Measures

Change in cognitive emotion regulation strategies

Measured by the Cognitive Emotion Regulation Questionnaire (CERQ)

Change in quality of life

Measured by the Quality of Life in Depression Scale (QLDS)

Remission from depression

Measured by the Remission of Depression Questionnaire (RDQ)

Resilience

Measured by the Connor-Davidson Resilience Scale (CD-RISC)

Full Information

NCT ID

NCT03278756

First Posted

August 18, 2017

Last Updated

November 8, 2022

Sponsor

University Ghent

1. Study Identification

Unique Protocol Identification Number

NCT03278756

Brief Title

Online Cognitive Control Training for Remitted Depressed Patients

Official Title

Online Cognitive Control Training for Remitted Depressed Patients

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

September 1, 2017 (Actual)

Primary Completion Date

March 13, 2019 (Actual)

Study Completion Date

March 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depression in Remission

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive Control Training

Arm Type

Experimental

Arm Description

Arm Title

Active Control Training

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Cognitive control training

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Active control training

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in depressive symptomatology

Description

Measured by the Beck Depression Inventory - II (BDI-II)

Time Frame

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

Title

Change in depressive symptomatology

Description

Measured by the Depression Anxiety Stress Scales (DASS)

Time Frame

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

Title

Change in depressive rumination (brooding)

Description

Measured by the Ruminative Response Scale (RRS), especially the brooding subscale

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in cognitive emotion regulation strategies

Description

Measured by the Cognitive Emotion Regulation Questionnaire (CERQ)

Time Frame

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

Title

Change in quality of life

Description

Measured by the Quality of Life in Depression Scale (QLDS)

Time Frame

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

Title

Remission from depression

Description

Measured by the Remission of Depression Questionnaire (RDQ)

Time Frame

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

Title

Resilience

Description

Measured by the Connor-Davidson Resilience Scale (CD-RISC)

Time Frame

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

Other Pre-specified Outcome Measures:

Title

User engagement

Description

Measured by the User Engagement Scale (UES)

Time Frame

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

Title

Threatening experiences

Description

Measured by the List of Threatening Experiences (LTE)

Time Frame

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

Title

Effortful control

Description

Measured by the subscale Effortful Control (EC) from the Adult Temperament Questionnaire (ATQ)

Time Frame

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

Title

Credibility and Expectancy

Description

Measured by the Credibility/Expectancy Questionnaire

Time Frame

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

Title

Behavioral measure for cognitive control

Description

Measured by the non-adaptive Paced Auditory Serial Addition Task (PASAT)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ernst HW Koster, PhD

Organizational Affiliation

University Ghent

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ghent University

City

Gent

State/Province

Oost-Vlaanderen

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Online Cognitive Control Training for Remitted Depressed Patients

We'll reach out to this number within 24 hrs