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Completed

NCT Number: NCT05166798

Optimal Dose of a Cognitive Control Training for Depression Vulnerability

This study aims to examine the dose-response relationship of an online adaptive cognitive control training on depressive symptomatology and rumination. Participants will be randomized over six groups, each receiving a different dose (0, 1, 5, 10, 15 or 20 sessions) of a cognitive control training in remitted depressed patients. An adaptive Paced Auditory Serial Addition Task will be used as cognitive control training.

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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, Belgium

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About this study

Depression is often associated with cognitive impairments and recent studies have found that for some people, these cognitive problems persist after remission of depression. These cognitive impairments could be a risk factor for recurrence of depressive episodes. Cognitive control training aims to address these cognitive impairments and decrease the risk of recurrence of depression.

One promising operationalization of cognitive control training is the adaptive Paced Auditory Serial Addition Task, but currently, it's unclear how many sessions one should complete in order to obtain cognitive- and emotional transfer effects. By comparing multiple groups with a different number of sessions (0, 1, 5, 10, 15 and 20), with measures at post (one month after baseline) and two follow-up periods (at 3 months and 6 months after baseline), this study examines the effects of an online cognitive control training on depressive vulnerability factors.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • History of ≥ 1 depressive episode(s)
  • Currently in remission (≥ 3 months)
  • Access to a computer with an internet connection

Exclusion criteria

  • Ongoing depressive episode
  • Psychotic disorder (current and/or previous)
  • Neurological impairments (current and/or previous)
  • Excessive substance abuse (current and/or previous)
  • Use of antidepressant medication is allowed if kept at a constant level

Treatment and study plan

Cognitive Control Training

Behavioral

The five intervention groups will receive either 1, 5, 10, 15 or 20 training sessions with the Adaptive Paced Auditory Serial Addition Task (aPASAT).

Primary outcomes

  1. Change in Beck Depression Inventory (BDI-II-NL)

    Time frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline

    Self-report questionnaire with 21 items, depression symptom severity, scores can range from 0 to 63, with higher scores indicating more severe depression.

Secondary outcomes

  1. Change in Perseverative Thinking Questionnaire (PTQ-NL)

    Time frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline

    Change from baseline in perseverative thinking. The PTQ-NL consist of 15 items and are assessed using scores ranging from 0 (never) to 4 (almost always). Lower scores indicate lower levels of preservative thinking.

  2. Change in Cognitive Emotion Regulation Questionnaire (CERQ)

    Time frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline

    Self-reported measure for emotion regulation: a 36-item questionnaire, consisting of 9 subscales (Self-blame, Other-blame, Rumination, Catastrophizing, Putting into Perspective, Positive Refocusing, Positive Reappraisal, Acceptance and Planning). Each item is rated on a 1 to 5 scale (1 = almost never and 5 = almost always). Higher subscale scores represent more frequent use of a specific cognitive strategy.

  3. Change in Adult Temperament Questionnaire (ATQ), Effortful Control subscale

    Time frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline

    Measured by the subscale Effortful Control (EC) from the Adult Temperament Questionnaire (ATQ).

  4. Change in Burnout Assessment Tool (BAT)

    Time frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline

    The Burnout Assessment Tool (BAT) is used to assess burn-out risk. The score ranges from 1 to 5, with higher scores indicating a higher risk of burn-out.

  5. Change in Remission from Depression Questionnaire (RDQ-NL)

    Time frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline

    The Remission from Depression Questionnaire has 41 items, which assess domains such as positive mental health, life satisfaction, and sense of well-being. The items are scored 0 (not at all or rarely true), 1 (sometimes true) or 2 (often or almost always true).

  6. Change in non-adaptive PASAT performance

    Time frame: baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline

    A non-adaptive computerized version of the Paced Auditory Serial- Addition Task (PASAT) was used as a measure of participants' working memory abilities. Higher accuracy scores suggest greater cognitive control resources.

  7. Change in n-back performance

    Time frame: baseline, post training (one month after baseline)

    The n-back task is a classic cognitive working memory task during which participants are asked to decide if a digit appearing on a screen is the same as the digit that appeared n stimuli earlier (n-back).

Other outcomes

  1. Change in List of Threatening Experiences (LTE-Q)

    Time frame: 3 month follow-up after baseline, 6 month follow-up after baseline

    In the LTE questionnaire, unpleased life events are listed and participants are asked if these events occurred recently. The LTE-Q contains 13 items for which "yes" or "no" are the two possible answers.

  2. Change in Credibility and Expectancy Questionnaire (CEQ)

    Time frame: baseline, post training (one month after baseline)

    The 6-item CEQ measures ratings of treatment credibility, acceptability/satisfaction, and expectations for success.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Research Foundation Flanders
  • University Hospital, Ghent

Registry information

Official study title

Establishing a Dose-response Relationship for the Effects of a Cognitive Control Training on Depression Vulnerability

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 22, 2021
Registry last updated
Jan 3, 2024

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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