Optimal Dose of a Cognitive Control Training for Depression Vulnerability

January 2, 2024 updated by: University Ghent

Establishing a Dose-response Relationship for the Effects of a Cognitive Control Training on Depression Vulnerability

This study aims to examine the dose-response relationship of an online adaptive cognitive control training on depressive symptomatology and rumination. Participants will be randomized over six groups, each receiving a different dose (0, 1, 5, 10, 15 or 20 sessions) of a cognitive control training in remitted depressed patients. An adaptive Paced Auditory Serial Addition Task will be used as cognitive control training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Depression is often associated with cognitive impairments and recent studies have found that for some people, these cognitive problems persist after remission of depression. These cognitive impairments could be a risk factor for recurrence of depressive episodes. Cognitive control training aims to address these cognitive impairments and decrease the risk of recurrence of depression.

One promising operationalization of cognitive control training is the adaptive Paced Auditory Serial Addition Task, but currently, it's unclear how many sessions one should complete in order to obtain cognitive- and emotional transfer effects. By comparing multiple groups with a different number of sessions (0, 1, 5, 10, 15 and 20), with measures at post (one month after baseline) and two follow-up periods (at 3 months and 6 months after baseline), this study examines the effects of an online cognitive control training on depressive vulnerability factors.

Study Type

Interventional

Enrollment (Actual)

216

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 Contact

Study Locations

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • History of ≥ 1 depressive episode(s)
  • Currently in remission (≥ 3 months)
  • Access to a computer with an internet connection

Exclusion Criteria:

  • Ongoing depressive episode
  • Psychotic disorder (current and/or previous)
  • Neurological impairments (current and/or previous)
  • Excessive substance abuse (current and/or previous)
  • 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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Cognitive control training: The adaptive Paced Auditory Serial Addition Task (aPASAT) is a Cognitive Control Training where participants need to click on the sum of the last two heard digits. Task difficulty is modified based on the participants' current task performance, allowing training of cognitive control. Five intervention groups will each receive a different amount of sessions.
Behavioral: Cognitive control training
The five intervention groups will receive either 1, 5, 10, 15 or 20 training sessions with the Adaptive Paced Auditory Serial Addition Task (aPASAT).
No Intervention: Control group
Waitlist control group: Participants randomized to the control group will not perform the cognitive control training during the study, but will be given the opportunity to follow the training afterwards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Beck Depression Inventory (BDI-II-NL)
Time Frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Self-report questionnaire with 21 items, depression symptom severity, scores can range from 0 to 63, with higher scores indicating more severe depression.
baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Perseverative Thinking Questionnaire (PTQ-NL)
Time Frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Change from baseline in perseverative thinking. The PTQ-NL consist of 15 items and are assessed using scores ranging from 0 (never) to 4 (almost always). Lower scores indicate lower levels of preservative thinking.
baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Change in Cognitive Emotion Regulation Questionnaire (CERQ)
Time Frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Self-reported measure for emotion regulation: a 36-item questionnaire, consisting of 9 subscales (Self-blame, Other-blame, Rumination, Catastrophizing, Putting into Perspective, Positive Refocusing, Positive Reappraisal, Acceptance and Planning). Each item is rated on a 1 to 5 scale (1 = almost never and 5 = almost always). Higher subscale scores represent more frequent use of a specific cognitive strategy.
baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Change in Adult Temperament Questionnaire (ATQ), Effortful Control subscale
Time Frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Measured by the subscale Effortful Control (EC) from the Adult Temperament Questionnaire (ATQ).
baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Change in Burnout Assessment Tool (BAT)
Time Frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
The Burnout Assessment Tool (BAT) is used to assess burn-out risk. The score ranges from 1 to 5, with higher scores indicating a higher risk of burn-out.
baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Change in Remission from Depression Questionnaire (RDQ-NL)
Time Frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
The Remission from Depression Questionnaire has 41 items, which assess domains such as positive mental health, life satisfaction, and sense of well-being. The items are scored 0 (not at all or rarely true), 1 (sometimes true) or 2 (often or almost always true).
baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Change in non-adaptive PASAT performance
Time Frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
A non-adaptive computerized version of the Paced Auditory Serial- Addition Task (PASAT) was used as a measure of participants' working memory abilities. Higher accuracy scores suggest greater cognitive control resources.
baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Change in n-back performance
Time Frame: baseline, post training (one month after baseline)
The n-back task is a classic cognitive working memory task during which participants are asked to decide if a digit appearing on a screen is the same as the digit that appeared n stimuli earlier (n-back).
baseline, post training (one month after baseline)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in List of Threatening Experiences (LTE-Q)
Time Frame: 3 month follow-up after baseline, 6 month follow-up after baseline
In the LTE questionnaire, unpleased life events are listed and participants are asked if these events occurred recently. The LTE-Q contains 13 items for which "yes" or "no" are the two possible answers.
3 month follow-up after baseline, 6 month follow-up after baseline
Change in Credibility and Expectancy Questionnaire (CEQ)
Time Frame: baseline, post training (one month after baseline)
The 6-item CEQ measures ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
baseline, post training (one month after baseline)

Collaborators and Investigators

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

Sponsor

University Ghent

Collaborators

University Hospital, Ghent
Research Foundation Flanders

Investigators

  • Principal Investigator: Ernst Koster, Professor, University Ghent

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 (Actual)

February 1, 2022

Primary Completion (Actual)

November 22, 2023

Study Completion (Actual)

November 22, 2023

Study Registration Dates

First Submitted

November 10, 2021

First Submitted That Met QC Criteria

December 7, 2021

First Posted (Actual)

December 22, 2021

Study Record Updates

Last Update Posted (Actual)

January 3, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-10551

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pseudonymized individual participant data can be stored on Open-Science Framework (OSF).

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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