Major Depression in RemissionNCT02407652
Cognitive Control Training for Remitted Depressed Patients
A study testing Low Cognitive Load Training in people with Major Depression in Remission, run by University Ghent at 1 site in Belgium.
Trial summary
The purpose of this study is to explore the effectiveness of an internet-delivered cognitive control training as a preventive intervention for remitted depressed patients. Read more about this study
- Who is it for?
- Ages 23 to 65 years
- Conditions the study is for
- Major Depression in Remission
- What is being tested?
- Low Cognitive Load Training
- 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
- Dec 2014to Oct 2015
- 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 23 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of ≥ 1 depressive episode(s)
- Currently in stable full or partial remission (≥ 6 months)
Who cannot join
- Major depressive disorder (MDD; current)
- Bipolar disorder (current and/or previous)
- Psychotic disorder (current and/or previous)
- Neurological impairments (current and/or previous)
- Excessive substance abuse (current and/or previous)
- No other comorbid disorders (current)
- No ongoing psychotherapeutic treatment (maintenance treatment is allowed, but with a frequency less than once / 3 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
Official title: Cognitive Control Training as a Preventive Intervention for Depression: A Double-blind Randomized Controlled Trial Study
The purpose of this study is to explore the effectiveness of an internet-delivered cognitive control training as a preventive intervention for remitted depressed patients.
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 samples. Furthermore, studies exploring the potential of cognitive control training in at-risk undergraduate students indicate that cognitive control training has beneficial effects on rumination, an important vulnerability factor for depression. Provided that remitted depressed patients form a high-risk group for developing future depressive episodes, the current study will explore whether internet-delivered cognitive control training can be used to reduce vulnerability for future depression in remitted depressed patients. The investigators will explore effects on depressive symptomatology, (mal-)adaptive emotion regulation (directly following training and at 3 months follow-up), and indices of functioning (at 3 months follow-up).
- Conditions
- Major Depression in Remission
- Being tested
- Cognitive Control Training, Low Cognitive Load Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Control TrainingBehavioural
10 adaptive Paced Auditory Serial Addition Task (PASAT) sessions, 400 trials each
Low Cognitive Load TrainingBehavioural
10 low cognitive load sessions, 400 trials each
| Study group | Role | What they receive |
|---|---|---|
| cognitive control training | Experimental | internet-delivered, 2 weeks Receives: Behavioral: Cognitive Control Training |
| low cognitive load training | Active comparator | internet-delivered, 2 weeks Receives: Behavioral: Low Cognitive Load Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive rumination from baseline to the post-training assessment and follow-up (RRS)
Assessed using the Ruminative Response Scale (RRS)
Measured: baseline, 2 weeks, 3 months
Change in depressive symptomatology from baseline to the post-training assessment and follow-up (BDI-II)
Assessed using the Beck Depression Inventory (BDI-II)
Measured: baseline, 2 weeks, 3 months
Secondary outcomes (5)
(mal-)Adaptive cognitive emotion regulation (CERQ)
Assessed using the Cognitive Emotion Regulation Questionnaire (CERQ)
Measured: baseline, 2 weeks, 3 months
Quality of Life (QLDS)
Assessed using the Quality of Life in Depression Scale (QLDS)
Measured: baseline, 3 months
Disability (WHODAS 2.0)
Assessed using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Measured: baseline, 3 months
Resilience (RS)
Assessed using the Resilience Scale (RS)
Measured: baseline, 3 months
Remission from depression (RDQ)
Assessed using the Remission of Depression Questionnaire (RDQ)
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startDec 2014
- Primary completionOct 2015
- Study completionOct 2015
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
- 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 Koster, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407652
- Sponsor's protocol ID
- B/13808/01-CCT-003
- Status last verified
- Dec 2015
- First submitted
- 10 Mar 2015
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hoorelbeke K, Koster EHW. Internet-delivered cognitive control training as a preventive intervention for remitted depressed patients: Evidence from a double-blind randomized controlled trial study. J Consult Clin Psychol. 2017 Feb;85(2):135-146. doi: 10.1037/ccp0000128. Epub 2016 Jun 30.
PubMed 27362792Hoorelbeke K, Faelens L, Behiels J, Koster EH. Internet-delivered cognitive control training as a preventive intervention for remitted depressed patients: Protocol for a randomized controlled trial. BMC Psychiatry. 2015 Jun 9;15:125. doi: 10.1186/s12888-015-0511-0.
PubMed 26055122
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Control Training as a Preventive Intervention for Depression: A Double-blind Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT02407652
- Acronym / sponsor ID
- B/13808/01-CCT-003
- Conditions
- Major Depression in Remission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 3 Apr 2015 (estimated)
- 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 purpose of this study is to explore the effectiveness of an internet-delivered cognitive control training as a preventive intervention for remitted depressed patients.
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 samples. Furthermore, studies exploring the potential of cognitive control training in at-risk undergraduate students indicate that cognitive control training has beneficial effects on rumination, an important vulnerability factor for depression. Provided that remitted depressed patients form a high-risk group for developing future depressive episodes, the current study will explore whether internet-delivered cognitive control training can be used to reduce vulnerability for future depression in remitted depressed patients. The investigators will explore effects on depressive symptomatology, (mal-)adaptive emotion regulation (directly following training and at 3 months follow-up), and indices of functioning (at 3 months follow-up).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive control training | Experimental | Behavioral: Cognitive Control Traininginternet-delivered, 2 weeks |
| low cognitive load training | Active comparator | Behavioral: Low Cognitive Load Traininginternet-delivered, 2 weeks |
Who may qualify
- Ages
- 23 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of ≥ 1 depressive episode(s)
- Currently in stable full or partial remission (≥ 6 months)
Key exclusion criteria (8 listed)
- Major depressive disorder (MDD; current)
- Bipolar disorder (current and/or previous)
- 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 adaptive Paced Auditory Serial Addition Task (PASAT) sessions, 400 trials each | Behavioural | cognitive control training |
| Low Cognitive Load Training10 low cognitive load sessions, 400 trials each | Behavioural | low cognitive load training |
Primary outcome
Change in depressive rumination from baseline to the post-training assessment and follow-up (RRS)
Time frame: baseline, 2 weeks, 3 months
Assessed using the Ruminative Response Scale (RRS)
Change in depressive symptomatology from baseline to the post-training assessment and follow-up (BDI-II)
Time frame: baseline, 2 weeks, 3 months
Assessed using the Beck Depression Inventory (BDI-II)
5 secondary outcomes
(mal-)Adaptive cognitive emotion regulation (CERQ)
Time frame: baseline, 2 weeks, 3 months
Quality of Life (QLDS)
Time frame: baseline, 3 months
Disability (WHODAS 2.0)
Time frame: baseline, 3 months
Resilience (RS)
Time frame: baseline, 3 months
Remission from depression (RDQ)
Time frame: baseline, 3 months
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 17 Dec 2015.
- Derived from this study: PubMed 27362792Hoorelbeke K, Koster EHW. Internet-delivered cognitive control training as a preventive intervention for remitted depressed patients: Evidence from a double-blind randomized controlled trial study. J Consult Clin Psychol. 2017 Feb;85(2):135-146. doi: 10.1037/ccp0000128. Epub 2016 Jun 30.
- Derived from this study: PubMed 26055122Hoorelbeke K, Faelens L, Behiels J, Koster EH. Internet-delivered cognitive control training as a preventive intervention for remitted depressed patients: Protocol for a randomized controlled trial. BMC Psychiatry. 2015 Jun 9;15:125. doi: 10.1186/s12888-015-0511-0.
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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, 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 testing Low Cognitive Load Training in people with 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 8 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 17 Dec 2015. 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 rumination from baseline to the post-training assessment and follow-up (RRS) (time frame: baseline, 2 weeks, 3 months). The study lists 2 primary outcomes in all. 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 NCT02407652, 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 17 Dec 2015.