Effects of Booster Sessions on Depression Vulnerability Following Cognitive Control Training

NCT05557760 | Unknown

• 1 other identifier: BC-11832
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Depression in Remission

Keywords

Depression; Remission; Relapse Prevention; Cognitive Control Training; Internet Intervention

Outcome Measures

Primary Outcomes (1)

• Change in Patient Health Questionnaire (PHQ-9)

  Self-report questionnaire measuring depression symptomatology, with higher scores indicating more severe depression symptoms.

  weekly assessments from baseline until follow-up (15 weeks after baseline)

Secondary Outcomes (10)

• Change in Beck Depression Inventory (BDI-II-NL)

  baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)

• Change in Perseverative Thinking Questionnaire (PTQ-NL)

  baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)

• Change in Cognitive Emotion Regulation Questionnaire (CERQ)

  baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)

• Change in Adult Temperament Questionnaire (ATQ), Effortful Control subscale

  baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)

• Change in Burnout Assessment Tool (BAT)

  baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)

Other Outcomes (1)

• Change in List of Threatening Experiences (LTE-Q)

  baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)

Study Arms (2)

Cognitive Control Training Group

EXPERIMENTAL

Behavioral: Cognitive Control Training (CCT)

Cognitive Control Training + Booster Sessions Group

EXPERIMENTAL

Behavioral: Cognitive Control Training (CCT) + Booster Sessions

Interventions

Cognitive Control Training (CCT) 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 Group

Cognitive Control Training (CCT) + Booster Sessions 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.

Cognitive Control Training + Booster Sessions Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead
• University Hospital, Ghent: collaborator
• Research Foundation Flanders: collaborator

Study Sites (2)

Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

NOT YET RECRUITING

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Ernst Koster, PhD

CONTACT

+ 32 9 2646446; Ernst.Koster@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 28, 2022
• Study Start: October 18, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE

Locations

BE (2)