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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05166798
Other study ID # BC-10551
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date November 22, 2023

Study information

Verified date January 2024
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 216
Est. completion date November 22, 2023
Est. primary completion date November 22, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

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).

Locations

Country Name City State
Belgium Ghent University Ghent Oost-Vlaanderen
Belgium Ghent University Hospital Ghent Oost-Vlaanderen

Sponsors (3)

Lead Sponsor Collaborator
University Ghent Research Foundation Flanders, University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in List of Threatening Experiences (LTE-Q) 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
Other Change in Credibility and Expectancy Questionnaire (CEQ) The 6-item CEQ measures ratings of treatment credibility, acceptability/satisfaction, and expectations for success. baseline, post training (one month after baseline)
Primary 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 Change in Perseverative Thinking Questionnaire (PTQ-NL) 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
Secondary Change in Cognitive Emotion Regulation Questionnaire (CERQ) 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
Secondary Change in Adult Temperament Questionnaire (ATQ), Effortful Control subscale 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
Secondary Change in Burnout Assessment Tool (BAT) 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
Secondary Change in Remission from Depression Questionnaire (RDQ-NL) 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
Secondary Change in non-adaptive PASAT performance 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
Secondary Change in n-back performance 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)
See also
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