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Online Cognitive Control Training for Remitted Depressed Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03278756
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
University Ghent

Brief 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 condition.

Condition or disease Intervention/treatment Phase
Major Depression in Remission Behavioral: Cognitive control training Behavioral: Active control training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Online Cognitive Control Training for Remitted Depressed Patients
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : March 13, 2019
Actual Study Completion Date : March 13, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive Control Training
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.
Behavioral: Cognitive control training
10 sessions of an adaptive paced auditory serial addition task, each lasting 15 minutes, over the course of two weeks.

Active Comparator: Active Control Training
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.
Behavioral: Active control training
10 sessions of an low cognitive load task, each lasting 15 minutes, over the course of two weeks.




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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


Secondary Outcome Measures :
  1. 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 ]
    Measured by the Cognitive Emotion Regulation Questionnaire (CERQ)

  2. 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 ]
    Measured by the Quality of Life in Depression Scale (QLDS)

  3. 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 ]
    Measured by the Remission of Depression Questionnaire (RDQ)

  4. 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 ]
    Measured by the Connor-Davidson Resilience Scale (CD-RISC)


Other Outcome Measures:
  1. User engagement [ Time Frame: Assessed at post-training assessment (within 1 week of completing the training) and at 3 months follow-up ]
    Measured by the User Engagement Scale (UES)

  2. Threatening experiences [ 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 List of Threatening Experiences (LTE)

  3. Effortful control [ Time Frame: Assessed at pre-training assessment and at 6 months follow-up ]
    Measured by the subscale Effortful Control (EC) from the Adult Temperament Questionnaire (ATQ)

  4. Credibility and Expectancy [ 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 Credibility/Expectancy Questionnaire

  5. Behavioral measure for cognitive control [ 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 non-adaptive Paced Auditory Serial Addition Task (PASAT)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • History of ≥ 1 depressive episodes (major or bipolar)
  • Currently in stable full or partial remission (≥ 3 months)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278756


Locations
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Belgium
Ghent University
Gent, Oost-Vlaanderen, Belgium, 9000
Sponsors and Collaborators
University Ghent
Investigators
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Principal Investigator: Ernst HW Koster, PhD University Ghent
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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT03278756    
Other Study ID Numbers: B/14730/RMD
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Ghent:
Depression
Remission
Relapse prevention
Cognitive control training
Internet intervention
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms