Effects of Booster Sessions on Depression Vulnerability Following Cognitive Control Training

NCT ID: NCT05557760

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-18
• Study Completion Date: 2024-09-30

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).

Conditions

Major Depression in Remission

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cognitive Control Training Group

Group Type: EXPERIMENTAL

Cognitive Control Training (CCT)

Intervention Type: BEHAVIORAL

The CCT training group without booster sessions will receive 10 training sessions with the Adaptive Paced Auditory Serial Addition Task (aPASAT). The 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.

Cognitive Control Training + Booster Sessions Group

Group Type: EXPERIMENTAL

Cognitive Control Training (CCT) + Booster Sessions

Intervention Type: BEHAVIORAL

The CCT with booster sessions group will receive 10 training sessions with the Adaptive Paced Auditory Serial Addition Task (aPASAT). After these training sessions, participants in this condition will be asked to complete additional CCT sessions after reporting two consecutive assessments of increased depressive symptoms during the monitoring period (PHQ-9 scores equal or greater to 9). Specifically, they will then be instructed to perform three additional sessions within one week. This may be repeated when the participant reports multiple consecutive assessments of increased depressive symptoms during the post-training phase, with a minimum of 3 weeks between the booster sessions and a maximum of 9 boosters (3 x 3 sessions) in total.

Interventions

Cognitive Control Training (CCT)

The CCT training group without booster sessions will receive 10 training sessions with the Adaptive Paced Auditory Serial Addition Task (aPASAT). The 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.

Intervention Type: BEHAVIORAL

Cognitive Control Training (CCT) + Booster Sessions

The CCT with booster sessions group will receive 10 training sessions with the Adaptive Paced Auditory Serial Addition Task (aPASAT). After these training sessions, participants in this condition will be asked to complete additional CCT sessions after reporting two consecutive assessments of increased depressive symptoms during the monitoring period (PHQ-9 scores equal or greater to 9). Specifically, they will then be instructed to perform three additional sessions within one week. This may be repeated when the participant reports multiple consecutive assessments of increased depressive symptoms during the post-training phase, with a minimum of 3 weeks between the booster sessions and a maximum of 9 boosters (3 x 3 sessions) in total.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: collaborator

Research Foundation Flanders

OTHER

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ghent University Hospital

Ghent, Oost-Vlaanderen, Belgium

Site Status: NOT_YET_RECRUITING

Ghent University

Ghent, Oost-Vlaanderen, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Ernst Koster, PhD

Role: CONTACT

Ernst.Koster@ugent.be

+ 32 9 2646446

Facility Contacts

Chris Baeken, PhD

Role: primary

Ernst Koster, PhD

Role: primary

Other Identifiers

BC-11832

Identifier Type: -

Identifier Source: org_study_id