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Optimal Dose of a Cognitive Control Training for Depression Vulnerability

Primary Purpose

Major Depression in Remission

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cognitive control training
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Major Depression in Remission focused on measuring Depression, Remission, Relapse prevention, Cognitive control training, Internet intervention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ghent University Hospital
  • Ghent UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Cognitive control training: The adaptive Paced Auditory Serial Addition Task (aPASAT) is a Cognitive Control Training where participants need to click on the sum of the last two heard digits. Task difficulty is modified based on the participants' current task performance, allowing training of cognitive control. Five intervention groups will each receive a different amount of sessions.

Waitlist control group: Participants randomized to the control group will not perform the cognitive control training during the study, but will be given the opportunity to follow the training afterwards.

Outcomes

Primary Outcome Measures

Change in Beck Depression Inventory (BDI-II-NL)
Self-report questionnaire with 21 items, depression symptom severity, scores can range from 0 to 63, with higher scores indicating more severe depression.

Secondary Outcome Measures

Change in Perseverative Thinking Questionnaire (PTQ-NL)
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.
Change in Cognitive Emotion Regulation Questionnaire (CERQ)
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.
Change in Adult Temperament Questionnaire (ATQ), Effortful Control subscale
Measured by the subscale Effortful Control (EC) from the Adult Temperament Questionnaire (ATQ).
Change in Burnout Assessment Tool (BAT)
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.
Change in Remission from Depression Questionnaire (RDQ-NL)
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).
Change in non-adaptive PASAT performance
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.
Change in n-back performance
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).

Full Information

First Posted
November 10, 2021
Last Updated
January 27, 2023
Sponsor
University Ghent
Collaborators
University Hospital, Ghent, Research Foundation Flanders
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1. Study Identification

Unique Protocol Identification Number
NCT05166798
Brief Title
Optimal Dose of a Cognitive Control Training for Depression Vulnerability
Official Title
Establishing a Dose-response Relationship for the Effects of a Cognitive Control Training on Depression Vulnerability
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
University Hospital, Ghent, Research Foundation Flanders

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression in Remission
Keywords
Depression, Remission, Relapse prevention, Cognitive control training, Internet intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Cognitive control training: The adaptive Paced Auditory Serial Addition Task (aPASAT) is a Cognitive Control Training where participants need to click on the sum of the last two heard digits. Task difficulty is modified based on the participants' current task performance, allowing training of cognitive control. Five intervention groups will each receive a different amount of sessions.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Waitlist control group: Participants randomized to the control group will not perform the cognitive control training during the study, but will be given the opportunity to follow the training afterwards.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive control training
Intervention Description
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 Outcome Measure Information:
Title
Change in Beck Depression Inventory (BDI-II-NL)
Description
Self-report questionnaire with 21 items, depression symptom severity, scores can range from 0 to 63, with higher scores indicating more severe depression.
Time Frame
baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Secondary Outcome Measure Information:
Title
Change in Perseverative Thinking Questionnaire (PTQ-NL)
Description
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.
Time Frame
baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Title
Change in Cognitive Emotion Regulation Questionnaire (CERQ)
Description
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.
Time Frame
baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Title
Change in Adult Temperament Questionnaire (ATQ), Effortful Control subscale
Description
Measured by the subscale Effortful Control (EC) from the Adult Temperament Questionnaire (ATQ).
Time Frame
baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Title
Change in Burnout Assessment Tool (BAT)
Description
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.
Time Frame
baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Title
Change in Remission from Depression Questionnaire (RDQ-NL)
Description
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).
Time Frame
baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Title
Change in non-adaptive PASAT performance
Description
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.
Time Frame
baseline, post training (one month after baseline), 3 month follow-up after baseline, 6 month follow-up after baseline
Title
Change in n-back performance
Description
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).
Time Frame
baseline, post training (one month after baseline)
Other Pre-specified Outcome Measures:
Title
Change in List of Threatening Experiences (LTE-Q)
Description
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.
Time Frame
3 month follow-up after baseline, 6 month follow-up after baseline
Title
Change in Credibility and Expectancy Questionnaire (CEQ)
Description
The 6-item CEQ measures ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
Time Frame
baseline, post training (one month after baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ernst Koster, Professor
Phone
+3292646446
Email
ernst.koster@ugent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernst Koster, Professor
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Baeken, Professor
First Name & Middle Initial & Last Name & Degree
Chris Baeken, PhD
First Name & Middle Initial & Last Name & Degree
Eveline Liebaert, MSc
Facility Name
Ghent University
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yannick Vander Zwalmen, MSc
Phone
+32(0)9-264-91-07
Email
y.vander.zwalmen@ugent.be
First Name & Middle Initial & Last Name & Degree
Ernst HW Koster, PhD
First Name & Middle Initial & Last Name & Degree
Kristof Hoorelbeke, PhD
First Name & Middle Initial & Last Name & Degree
Nick Verhaeghe, PhD
First Name & Middle Initial & Last Name & Degree
Yannick Vander Zwalmen, MSc

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pseudonymized individual participant data can be stored on Open-Science Framework (OSF).

Learn more about this trial

Optimal Dose of a Cognitive Control Training for Depression Vulnerability

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