Clinical trial NCT05166798: Optimal Dose of a Cognitive Control Training for Depression Vulnerability
Official title: Establishing a Dose-response Relationship for the Effects of a Cognitive Control Training on Depression Vulnerability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression in Remission
Keywords: Depression
Remission
Relapse prevention
Cognitive control training
Internet intervention
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
name: Research Foundation Flanders
First posted: 2021-12-22
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Beck Depression Inventory (BDI-II-NL)
timeFrame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Secondary outcomes:
measure: Change in Perseverative Thinking Questionnaire (PTQ-NL)
timeFrame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
measure: Change in Cognitive Emotion Regulation Questionnaire (CERQ)
timeFrame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
measure: Change in Adult Temperament Questionnaire (ATQ), Effortful Control subscale
timeFrame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
measure: Change in Burnout Assessment Tool (BAT)
timeFrame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
measure: Change in Remission from Depression Questionnaire (RDQ-NL)
timeFrame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
measure: Change in non-adaptive PASAT performance
timeFrame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
measure: Change in n-back performance
timeFrame: baseline, post training (one month after baseline)
Other outcomes:
measure: Change in List of Threatening Experiences (LTE-Q)
timeFrame: 3 month follow-up after baseline, 6 month follow-up after baseline
measure: Change in Credibility and Expectancy Questionnaire (CEQ)
timeFrame: baseline, post training (one month after baseline)
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: Oost-Vlaanderen
city: Ghent
country: Belgium
facility: Ghent University
state: Oost-Vlaanderen
Study officials:
affiliation: University Ghent
name: Ernst Koster, Professor
role: PRINCIPAL_INVESTIGATOR
References: