Clinical trial NCT05557760: Effects of Booster Sessions on Depression Vulnerability Following Cognitive Control Training
Official title: Evaluating the Effects of Personalized Booster Sessions on Depression Vulnerability Following Cognitive Control Training for Remitted Depressed Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
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: 2022-09-28
Enrollment: 138
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: The current study aims to examine the impact of booster sessions of cognitive control training (CCT) on indicators of depression vulnerability. Remitted depressed individuals (RMD) will be randomized over two groups, each receiving 10 sessions of the adaptive Paced Auditory Serial Addition Task, a well-established CCT procedure (Koster et al., 2017; Siegle et al., 2007). During and following completion of the training procedure, functioning will be monitored on a weekly basis over a period of 15 weeks. During this period, one group will be offered booster sessions based on early warning signs for possible recurrence of depression, whilst the other group will not receive booster sessions.

Detailed description: Cognitive impairments are closely associated with depression and recent studies have found that these cognitive problems can persist following remission of depression. Internet-delivered cognitive control training (CCT), and the adaptive Paced Auditory Serial Addition Task (aPASAT) in particular, has shown to be an effective preventative intervention for remitted depressed individuals (RMD), where beneficial effects have been found for rumination, depressive symptomatology (Hoorelbeke \& Koster, 2017), and risk for recurrence of depression (Hoorelbeke et al., 2021). At the same time, prior studies suggest significant heterogeneity in response to CCT, where RMD individuals can show strong fluctuations in functioning in the months following completion of aPASAT training. In line with this, recent findings suggest that, for individuals with high-risk profiles, initial training gains may diminish over time, resulting in recurrence of internalizing symptomatology (Hoorelbeke et al., 2022). As such, there may be merit in the use of CCT booster sessions.

Currently, it is unclear whether offering additional CCT sessions when RMD individuals are reporting increased symptomatology (i.e., adding booster sessions based on early warning signs for possible recurrence of depression) can increase the long-term effectiveness of CCT. In this study, two groups of RMD individuals will perform 10 CCT sessions, after which one group will be offered booster sessions (contingent on indicators of functioning). For this purpose, we will rely on 15 weekly mobile assessments, using the PHQ-9 questionnaire. In addition, functioning will be assessed using a more extensive assessment battery at baseline, post-training (2 weeks after baseline) and follow-up (15 weeks after baseline).

Eligibility criteria: Inclusion Criteria:

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

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 Patient Health Questionnaire (PHQ-9)
timeFrame: weekly assessments from baseline until follow-up (15 weeks after baseline)
Secondary outcomes:
measure: Change in Beck Depression Inventory (BDI-II-NL)
timeFrame: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
measure: Change in Perseverative Thinking Questionnaire (PTQ-NL)
timeFrame: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
measure: Change in Cognitive Emotion Regulation Questionnaire (CERQ)
timeFrame: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
measure: Change in Adult Temperament Questionnaire (ATQ), Effortful Control subscale
timeFrame: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
measure: Change in Burnout Assessment Tool (BAT)
timeFrame: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
measure: Change in Remission from Depression Questionnaire (RDQ-NL)
timeFrame: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
measure: Change in non-adaptive PASAT performance
timeFrame: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
measure: Change in Work Productivity and Activity Impairment Questionnaire (WPAI)
timeFrame: baseline, follow-up (15 weeks after baseline)
measure: Change in Short Form Health Survey (SF-36)
timeFrame: baseline, follow-up (15 weeks after baseline)
measure: Change in questionnaire based on the Medical Consumption Questionnaire (iMCQ)
timeFrame: baseline, follow-up (15 weeks after baseline)
Other outcomes:
measure: Change in List of Threatening Experiences (LTE-Q)
timeFrame: baseline, post training (2 weeks after baseline), follow-up (15 weeks 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:
References: