Major Depression in RemissionNCT05557760
Effects of Booster Sessions on Depression Vulnerability Following Cognitive Control Training
A study of Major Depression in Remission, run by University Ghent at 2 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression in Remission
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesBelgium
- Study dates
- 18 Oct 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of ≥ 1 depressive episode(s)
- Currently in remission (≥ 3 months)
- Access to a computer with an internet connection
- Access to a smartphone
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Not yet recruiting
Ghent University Hospital
Ghent, Oost-Vlaanderen, 9000
Chris Baeken, PhD
Chris Baeken, PhD
- Recruiting
Ghent University
Ghent, Oost-Vlaanderen, 9000
Ernst Koster, PhD
Ernst HW Koster, PhD
About this study
Official title: Evaluating the Effects of Personalized Booster Sessions on Depression Vulnerability Following Cognitive Control Training for Remitted Depressed Individuals
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.
Read the 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
- Being tested
- Cognitive Control Training (CCT), Cognitive Control Training (CCT) + Booster Sessions
- Keywords
- Depression, Remission, Relapse Prevention, Cognitive Control Training, Internet Intervention
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Control Training (CCT)Behavioural
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 (CCT) + Booster SessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Control Training Group | Experimental | Not described Receives: Behavioral: Cognitive Control Training (CCT) |
| Cognitive Control Training + Booster Sessions Group | Experimental | Not described Receives: Behavioral: Cognitive Control Training (CCT) + Booster Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire (PHQ-9)
Self-report questionnaire measuring depression symptomatology, with higher scores indicating more severe depression symptoms.
Measured: weekly assessments from baseline until follow-up (15 weeks after baseline)
Secondary outcomes (10)
Change in Beck Depression Inventory (BDI-II-NL)
Self-report questionnaire measuring depression symptomatology, with higher scores indicating more severe depression symptoms.
Measured: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
Change in Perseverative Thinking Questionnaire (PTQ-NL)
Change from baseline in repetitive negative thinking. The PTQ-NL consist of 15 items which are rated from 0 (never) to 4 (almost always). Lower scores indicate lower levels of repetitive negative thinking.
Measured: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
Change in Cognitive Emotion Regulation Questionnaire (CERQ)
Self-report measure for emotion regulation: a 36-item questionnaire, consisting of adaptive and maladaptive emotion regulation strategies. Each item is rated on a 1 to 5 scale (1 = almost never and 5 = almost always).
Measured: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
Change in Adult Temperament Questionnaire (ATQ), Effortful Control subscale
Measured by the subscale Effortful Control (EC) from the Adult Temperament Questionnaire (ATQ).
Measured: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
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
Measured: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
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).
Measured: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
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.
Measured: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
Change in Work Productivity and Activity Impairment Questionnaire (WPAI)
The 6-item WPAI measures the effect of health problems on the ability to work and carry out daily activities.
Measured: baseline, follow-up (15 weeks after baseline)
Change in Short Form Health Survey (SF-36)
The 11-item SF-36 measures attitudes on general health.
Measured: baseline, follow-up (15 weeks after baseline)
Change in questionnaire based on the Medical Consumption Questionnaire (iMCQ)
The iMCQ measures healthcare consumption.
Measured: baseline, follow-up (15 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start18 Oct 2022
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depression in RemissionStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent, Research Foundation Flanders
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557760
- Sponsor's protocol ID
- BC-11832
- Status last verified
- Nov 2023
- First submitted
- 21 Sep 2022
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymized individual participant data can be stored on Open-Science Framework (OSF).
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Personalized Booster Sessions on Depression Vulnerability Following Cognitive Control Training for Remitted Depressed Individuals
- ClinicalTrials.gov ID
- NCT05557760
- Acronym / sponsor ID
- BC-11832
- Conditions
- Major Depression in Remission
- Keywords
- Depression, Remission, Relapse Prevention, Cognitive Control Training, Internet Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University Hospital, Ghent, Research Foundation Flanders
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Control Training Group | Experimental | Behavioral: Cognitive Control Training (CCT) |
| Cognitive Control Training + Booster Sessions Group | Experimental | Behavioral: Cognitive Control Training (CCT) + Booster Sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of ≥ 1 depressive episode(s)
- Currently in remission (≥ 3 months)
- Access to a computer with an internet connection
- Access to a smartphone
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Cognitive Control Training Group |
| Cognitive Control Training (CCT) + Booster SessionsThe 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. | Behavioural | Cognitive Control Training + Booster Sessions Group |
Primary outcome
Change in Patient Health Questionnaire (PHQ-9)
Time frame: weekly assessments from baseline until follow-up (15 weeks after baseline)
Self-report questionnaire measuring depression symptomatology, with higher scores indicating more severe depression symptoms.
10 secondary outcomes
Change in Beck Depression Inventory (BDI-II-NL)
Time frame: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
Change in Perseverative Thinking Questionnaire (PTQ-NL)
Time frame: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
Change in Cognitive Emotion Regulation Questionnaire (CERQ)
Time frame: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
Change in Adult Temperament Questionnaire (ATQ), Effortful Control subscale
Time frame: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
Change in Burnout Assessment Tool (BAT)
Time frame: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
Change in Remission from Depression Questionnaire (RDQ-NL)
Time frame: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
Change in non-adaptive PASAT performance
Time frame: baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline)
Change in Work Productivity and Activity Impairment Questionnaire (WPAI)
Time frame: baseline, follow-up (15 weeks after baseline)
Change in Short Form Health Survey (SF-36)
Time frame: baseline, follow-up (15 weeks after baseline)
Change in questionnaire based on the Medical Consumption Questionnaire (iMCQ)
Time frame: baseline, follow-up (15 weeks after baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: Yes. Pseudonymized individual participant data can be stored on Open-Science Framework (OSF).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Major Depression in Remission, run by University Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ernst Koster, PhD (+ 32 9 2646446, Ernst.Koster@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire (PHQ-9) (time frame: weekly assessments from baseline until follow-up (15 weeks after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.