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Online Cognitive Control Training for Remitted Depressed Patients

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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

Tracking Information
First Submitted Date  ICMJE August 18, 2017
First Posted Date  ICMJE September 12, 2017
Last Update Posted Date March 15, 2019
Actual Study Start Date  ICMJE September 1, 2017
Actual Primary Completion Date March 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
  • 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)
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 8, 2017)
  • 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)
  • 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)
  • 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)
  • 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
  • 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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Online Cognitive Control Training for Remitted Depressed Patients
Official Title  ICMJE Online Cognitive Control Training for Remitted Depressed Patients
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Major Depression in Remission
Intervention  ICMJE
  • Behavioral: Cognitive control training
    10 sessions of an adaptive paced auditory serial addition task, each lasting 15 minutes, over the course of two weeks.
  • Behavioral: Active control training
    10 sessions of an low cognitive load task, each lasting 15 minutes, over the course of two weeks.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Cognitive control training
  • 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.
    Intervention: Behavioral: Active control training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2017)
68
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 13, 2019
Actual Primary Completion Date March 13, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03278756
Other Study ID Numbers  ICMJE B/14730/RMD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Ghent
Study Sponsor  ICMJE University Ghent
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ernst HW Koster, PhD University Ghent
PRS Account University Ghent
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP