Major Depression in RemissionNCT03278756
Online Cognitive Control Training for Remitted Depressed Patients
A study of Major Depression in Remission, run by University Ghent at 1 site in Belgium.
Trial summary
This study evaluates the effectiveness of an internet-delivered cognitive control training as a preventive intervention for remitted depressed patients. Half of the participants will receive a cognitive control training, while the other half will receive a low cognitive load training that acts as an active control… 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
- 68 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2017to 13 Mar 2019
- 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 episodes (major or bipolar)
- Currently in stable full or partial remission (≥ 3 months)
Who cannot join
- Major depressive disorder (current or less than 3 months in remission)
- Bipolar disorder (current or less than 3 months in remission)
- Psychotic disorder (current and/or previous)
- Neurological impairments (current and/or previous)
- Excessive substance abuse (current and/or previous)
- No ongoing psychotherapeutic treatment (maintenance treatment is allowed, but with a frequency of less than once every three weeks)
- Use of antidepressant medication is allowed if kept at a constant level
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the effectiveness of an internet-delivered cognitive control training as a preventive intervention for remitted depressed patients. Half of the participants will receive a cognitive control training, while the other half will receive a low cognitive load training that acts as an active control condition.
Read the detailed description
Prospective studies have linked impaired cognitive control to increased cognitive vulnerability for future depression. Importantly, experimental studies indicate that cognitive control training can be used to reduce rumination and depressive symptomatology in MDD (major depressive disorder) and RMD (remitted depressed) samples. Provided that remitted depressed patients form a high-risk group for developing future depressive episodes, the current study will explore whether an internet-delivered cognitive control training can be used to reduce vulnerability for future depression in remitted depressed patients.
A computer training, consisting of 10 sessions of 15 minutes each, will be administered to participants, which are remitted depressed patients. This training can either be a cognitive control training, using an adaptive paced auditory serial addition task, or an active control training, with a low cognitive load task.
Dependent variables will be assessed pre- and post-training, as well as 3 and 6 months after the training, and consist of depressive symptomatology, related variables and cognitive control measures.
- Conditions
- Major Depression in Remission
- Being tested
- Cognitive control training, Active 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
10 sessions of an adaptive paced auditory serial addition task, each lasting 15 minutes, over the course of two weeks.
Active control trainingBehavioural
10 sessions of an low cognitive load task, each lasting 15 minutes, over the course of two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Control Training | Experimental | A cognitive control training, consisting of 10 sessions of 15 minutes each, will be administered. The task in this training is an adaptive paced auditory serial addition task, where participants need to click on the sum of the last two heard digits. Receives: Behavioral: Cognitive control training |
| Active Control Training | Active comparator | An active control training, consisting of 10 sessions of 15 minutes each, will be administered. The task in this training is an adaptive low load cognitive task, where participants need to click on the last heard digit. Receives: Behavioral: Active control training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptomatology
Measured by the Beck Depression Inventory - II (BDI-II)
Measured: Assessed at pre-training assessment and at 6 months follow-up
Change in depressive symptomatology
Measured by the Depression Anxiety Stress Scales (DASS)
Measured: Assessed at pre-training assessment, at post-training assessment (within 1 week of completing the training), at 3 months follow-up and at 6 months follow-up
Change in depressive rumination (brooding)
Measured by the Ruminative Response Scale (RRS), especially the brooding subscale
Measured: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Secondary outcomes (4)
Change in cognitive emotion regulation strategies
Measured by the Cognitive Emotion Regulation Questionnaire (CERQ)
Measured: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Change in quality of life
Measured by the Quality of Life in Depression Scale (QLDS)
Measured: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Remission from depression
Measured by the Remission of Depression Questionnaire (RDQ)
Measured: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Resilience
Measured by the Connor-Davidson Resilience Scale (CD-RISC)
Measured: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Sep 2017
- Primary completion13 Mar 2019
- Study completion13 Mar 2019
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.
- 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
- Model description
- Between subjects-design with two training conditions. The training condition is the only difference between the two groups during the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ernst HW Koster, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278756
- Sponsor's protocol ID
- B/14730/RMD
- Status last verified
- Nov 2022
- First submitted
- 18 Aug 2017
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Cognitive Control Training for Remitted Depressed Patients
- ClinicalTrials.gov ID
- NCT03278756
- Acronym / sponsor ID
- B/14730/RMD
- Conditions
- Major Depression in Remission
- Keywords
- Depression, Remission, Relapse prevention, Cognitive control training, Internet intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 13 Mar 2019 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 12 Sep 2017 (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 evaluates the effectiveness of an internet-delivered cognitive control training as a preventive intervention for remitted depressed patients. Half of the participants will receive a cognitive control training, while the other half will receive a low cognitive load training that acts as an active control condition.
Detailed description
Prospective studies have linked impaired cognitive control to increased cognitive vulnerability for future depression. Importantly, experimental studies indicate that cognitive control training can be used to reduce rumination and depressive symptomatology in MDD (major depressive disorder) and RMD (remitted depressed) samples. Provided that remitted depressed patients form a high-risk group for developing future depressive episodes, the current study will explore whether an internet-delivered cognitive control training can be used to reduce vulnerability for future depression in remitted depressed patients.
A computer training, consisting of 10 sessions of 15 minutes each, will be administered to participants, which are remitted depressed patients. This training can either be a cognitive control training, using an adaptive paced auditory serial addition task, or an active control training, with a low cognitive load task.
Dependent variables will be assessed pre- and post-training, as well as 3 and 6 months after the training, and consist of depressive symptomatology, related variables and cognitive control measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Between subjects-design with two training conditions. The training condition is the only difference between the two groups during the study.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Control Training | Experimental | Behavioral: Cognitive control trainingA cognitive control training, consisting of 10 sessions of 15 minutes each, will be administered. The task in this training is an adaptive paced auditory serial addition task, where participants need to click on the sum of the last two heard digits. |
| Active Control Training | Active comparator | Behavioral: Active control trainingAn active control training, consisting of 10 sessions of 15 minutes each, will be administered. The task in this training is an adaptive low load cognitive task, where participants need to click on the last heard digit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of ≥ 1 depressive episodes (major or bipolar)
- Currently in stable full or partial remission (≥ 3 months)
Key exclusion criteria (7 listed)
- Major depressive disorder (current or less than 3 months in remission)
- Bipolar disorder (current or less than 3 months in remission)
- Psychotic disorder (current and/or previous)
- Neurological impairments (current and/or previous)
- Excessive substance abuse (current and/or previous)
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 training10 sessions of an adaptive paced auditory serial addition task, each lasting 15 minutes, over the course of two weeks. | Behavioural | Cognitive Control Training |
| Active control training10 sessions of an low cognitive load task, each lasting 15 minutes, over the course of two weeks. | Behavioural | Active Control Training |
Primary outcome
Change in depressive symptomatology
Time frame: Assessed at pre-training assessment and at 6 months follow-up
Measured by the Beck Depression Inventory - II (BDI-II)
Change in depressive symptomatology
Time frame: Assessed at pre-training assessment, at post-training assessment (within 1 week of completing the training), at 3 months follow-up and at 6 months follow-up
Measured by the Depression Anxiety Stress Scales (DASS)
Change in depressive rumination (brooding)
Time frame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Measured by the Ruminative Response Scale (RRS), especially the brooding subscale
4 secondary outcomes
Change in cognitive emotion regulation strategies
Time frame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Change in quality of life
Time frame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Remission from depression
Time frame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Resilience
Time frame: Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
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 9 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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 HW Koster, PhD principal investigator
University Ghent
1 site 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 1 site 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 2 inclusion and 7 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 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 depressive symptomatology (time frame: Assessed at pre-training assessment and at 6 months follow-up). The study lists 3 primary outcomes in all. 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 2022.