Optimal Dose of a Cognitive Control Training for Depression Vulnerability

NCT05166798 | Completed

• 1 other identifier: BC-10551
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Major Depression in Remission

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Beck Depression Inventory (BDI-II-NL)

  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 Outcomes (7)

• Change in Perseverative Thinking Questionnaire (PTQ-NL)

  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)

  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

  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)

  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)

  baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline

Other Outcomes (2)

• Change in List of Threatening Experiences (LTE-Q)

  3 month follow-up after baseline, 6 month follow-up after baseline

• Change in Credibility and Expectancy Questionnaire (CEQ)

  baseline, post training (one month after baseline)

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Cognitive control training BEHAVIORAL

The five intervention groups will receive either 1, 5, 10, 15 or 20 training sessions with the Adaptive Paced Auditory Serial Addition Task (aPASAT).

Intervention group

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead
• University Hospital, Ghent: collaborator
• Research Foundation Flanders: collaborator

Study Sites (2)

Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (2)

• Vander Zwalmen Y, Demeester D, Hoorelbeke K, Verhaeghe N, Baeken C, Koster EHW. The more, the merrier? Establishing a dose-response relationship for the effects of cognitive control training on depressive symptomatology. J Consult Clin Psychol. 2025 Mar;93(3):161-175. doi: 10.1037/ccp0000945.

  PMID: 40014506 DERIVED

• Vander Zwalmen Y, Hoorelbeke K, Demeester D, Koster EHW. High-Frequency Cognitive Control Training for Depression: Case Report. JMIR Form Res. 2024 Nov 29;8:e56598. doi: 10.2196/56598.

  PMID: 39612206 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Ernst Koster, Professor

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 22, 2021
• Study Start: February 1, 2022
• Primary Completion: November 22, 2023
• Study Completion: November 22, 2023
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE

Locations

BE (2)