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Completed

NCT Number: NCT03278756

Online Cognitive Control Training for Remitted Depressed Patients

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.

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Key information

Conditions

Major Depression in Remission Behavior Behavioral Symptoms Depression

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Control Training

Behavioral

10 sessions of an adaptive paced auditory serial addition task, each lasting 15 minutes, over the course of two weeks.

Active control training

Behavioral

10 sessions of an low cognitive load task, each lasting 15 minutes, over the course of two weeks.

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2017
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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