Optimal Dose of a Cognitive Control Training for Depression Vulnerability

NCT ID: NCT05166798

Last Updated: 2024-01-03

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

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-11-22

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Major Depression in Remission

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive control training

Intervention Type 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).

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role collaborator

Research Foundation Flanders

OTHER

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ernst Koster, Professor

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

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Ghent University Hospital

Ghent, Oost-Vlaanderen, Belgium

Site Status

Ghent University

Ghent, Oost-Vlaanderen, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 40014506 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39612206 (View on PubMed)

Other Identifiers

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BC-10551

Identifier Type: -

Identifier Source: org_study_id

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