Major Depression in RemissionNCT05166798
Optimal Dose of a Cognitive Control Training for Depression Vulnerability
A study of Major Depression in Remission, run by University Ghent at 2 sites in Belgium.
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… 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
- 216 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Feb 2022to 22 Nov 2023
- 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
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
Ghent University Hospital
Ghent, Oost-Vlaanderen, 9000
Ghent University
Ghent, Oost-Vlaanderen, 9000
About this study
Official title: Establishing a Dose-response Relationship for the Effects of a Cognitive Control Training on Depression Vulnerability
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.
Read the detailed 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.
- Conditions
- Major Depression in Remission
- Being tested
- Cognitive control training
- 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 trainingBehavioural
The five intervention groups will receive either 1, 5, 10, 15 or 20 training sessions with the Adaptive Paced Auditory Serial Addition Task (aPASAT).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Cognitive control training: The adaptive Paced Auditory Serial Addition Task (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. Five intervention groups will each receive a different amount of sessions. Receives: Behavioral: Cognitive control training |
| Control group | No intervention | Waitlist control group: Participants randomized to the control group will not perform the cognitive control training during the study, but will be given the opportunity to follow the training afterwards. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Secondary outcomes (7)
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.
Measured: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
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.
Measured: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up 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 (one month after baseline), 3 month follow-up after baseline, 6 month follow-up 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 (one month after baseline), 3 month follow-up after baseline, 6 month follow-up 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 (one month after baseline), 3 month follow-up after baseline, 6 month follow-up 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 (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
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).
Measured: baseline, post training (one month after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Feb 2022
- Primary completion22 Nov 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depression in RemissionStudies of the same condition, open and under way.
- 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
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent, Research Foundation Flanders
- Responsible party
- Sponsor
- Investigators
- Ernst Koster, Professor, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166798
- Sponsor's protocol ID
- BC-10551
- Status last verified
- Jan 2024
- First submitted
- 10 Nov 2021
- Last updated
- 3 Jan 2024
- 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).
Publications
Vander Zwalmen Y, Demeester D, Hoorelbeke K, Verhaeghe N, Baeken C, Koster EHW. The more, the merrier? Establishing a dose-response relationship for the effects of cognitive control training on depressive symptomatology. J Consult Clin Psychol. 2025 Mar;93(3):161-175. doi: 10.1037/ccp0000945.
PubMed 40014506Vander Zwalmen Y, Hoorelbeke K, Demeester D, Koster EHW. High-Frequency Cognitive Control Training for Depression: Case Report. JMIR Form Res. 2024 Nov 29;8:e56598. doi: 10.2196/56598.
PubMed 39612206
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Dose-response Relationship for the Effects of a Cognitive Control Training on Depression Vulnerability
- ClinicalTrials.gov ID
- NCT05166798
- Acronym / sponsor ID
- BC-10551
- Conditions
- Major Depression in Remission
- Keywords
- Depression, Remission, Relapse prevention, Cognitive control training, Internet intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University Hospital, Ghent, Research Foundation Flanders
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 22 Dec 2021 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Cognitive control trainingCognitive control training: The adaptive Paced Auditory Serial Addition Task (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. Five intervention groups will each receive a different amount of sessions. |
| Control group | No intervention | –Waitlist control group: Participants randomized to the control group will not perform the cognitive control training during the study, but will be given the opportunity to follow the training afterwards. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of ≥ 1 depressive episode(s)
- Currently in remission (≥ 3 months)
- Access to a computer with an internet connection
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 trainingThe five intervention groups will receive either 1, 5, 10, 15 or 20 training sessions with the Adaptive Paced Auditory Serial Addition Task (aPASAT). | Behavioural | Intervention group |
Primary outcome
Change in Beck Depression Inventory (BDI-II-NL)
Time frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Self-report questionnaire with 21 items, depression symptom severity, scores can range from 0 to 63, with higher scores indicating more severe depression.
7 secondary outcomes
Change in Perseverative Thinking Questionnaire (PTQ-NL)
Time frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Change in Cognitive Emotion Regulation Questionnaire (CERQ)
Time frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Change in Adult Temperament Questionnaire (ATQ), Effortful Control subscale
Time frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Change in Burnout Assessment Tool (BAT)
Time frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Change in Remission from Depression Questionnaire (RDQ-NL)
Time frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Change in non-adaptive PASAT performance
Time frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Change in n-back performance
Time frame: baseline, post training (one month after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Derived from this study: PubMed 40014506Vander Zwalmen Y, Demeester D, Hoorelbeke K, Verhaeghe N, Baeken C, Koster EHW. The more, the merrier? Establishing a dose-response relationship for the effects of cognitive control training on depressive symptomatology. J Consult Clin Psychol. 2025 Mar;93(3):161-175. doi: 10.1037/ccp0000945.
- Derived from this study: PubMed 39612206Vander Zwalmen Y, Hoorelbeke K, Demeester D, Koster EHW. High-Frequency Cognitive Control Training for Depression: Case Report. JMIR Form Res. 2024 Nov 29;8:e56598. doi: 10.2196/56598.
- 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.
Ernst Koster, Professor principal investigator
University Ghent
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 3 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: finished, as of the sponsor's last update on 3 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Beck Depression Inventory (BDI-II-NL) (time frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05166798, which also lists 2 linked publications.
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 3 Jan 2024.