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Cognitive Control Training for Remitted Depressed Patients

Primary Purpose

Major Depression in Remission

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Cognitive Control Training

Low Cognitive Load Training

About this trial

This is an interventional prevention trial for Major Depression in Remission

Eligibility Criteria

23 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

History of ≥ 1 depressive episode(s)
Currently in stable full or partial remission (≥ 6 months)

Exclusion Criteria:

Major depressive disorder (MDD; current)
Bipolar disorder (current and/or previous)
Psychotic disorder (current and/or previous)
Neurological impairments (current and/or previous)
Excessive substance abuse (current and/or previous)
No other comorbid disorders (current)
No ongoing psychotherapeutic treatment (maintenance treatment is allowed, but with a frequency less than once / 3 weeks)
Use of antidepressant medication is allowed if kept at a constant level

Sites / Locations

Ghent University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cognitive control training

low cognitive load training

Arm Description

internet-delivered, 2 weeks

Outcomes

Primary Outcome Measures

Change in depressive rumination from baseline to the post-training assessment and follow-up (RRS)

Assessed using the Ruminative Response Scale (RRS)

Change in depressive symptomatology from baseline to the post-training assessment and follow-up (BDI-II)

Assessed using the Beck Depression Inventory (BDI-II)

Secondary Outcome Measures

(mal-)Adaptive cognitive emotion regulation (CERQ)

Assessed using the Cognitive Emotion Regulation Questionnaire (CERQ)

Quality of Life (QLDS)

Assessed using the Quality of Life in Depression Scale (QLDS)

Disability (WHODAS 2.0)

Assessed using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

Resilience (RS)

Assessed using the Resilience Scale (RS)

Remission from depression (RDQ)

Assessed using the Remission of Depression Questionnaire (RDQ)

Full Information

NCT ID

NCT02407652

First Posted

March 10, 2015

Last Updated

December 16, 2015

Sponsor

University Ghent

1. Study Identification

Unique Protocol Identification Number

NCT02407652

Brief Title

Cognitive Control Training for Remitted Depressed Patients

Official Title

Cognitive Control Training as a Preventive Intervention for Depression: A Double-blind Randomized Controlled Trial Study

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

December 2014 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Ghent

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to explore the effectiveness of an internet-delivered cognitive control training as a preventive intervention for remitted depressed patients.

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 samples. Furthermore, studies exploring the potential of cognitive control training in at-risk undergraduate students indicate that cognitive control training has beneficial effects on rumination, an important vulnerability factor for depression. Provided that remitted depressed patients form a high-risk group for developing future depressive episodes, the current study will explore whether internet-delivered cognitive control training can be used to reduce vulnerability for future depression in remitted depressed patients. The investigators will explore effects on depressive symptomatology, (mal-)adaptive emotion regulation (directly following training and at 3 months follow-up), and indices of functioning (at 3 months follow-up).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depression in Remission

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cognitive control training

Arm Type

Experimental

Arm Description

internet-delivered, 2 weeks

Arm Title

low cognitive load training

Arm Type

Active Comparator

Arm Description

internet-delivered, 2 weeks

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Control Training

Intervention Description

10 adaptive Paced Auditory Serial Addition Task (PASAT) sessions, 400 trials each

Intervention Type

Behavioral

Intervention Name(s)

Low Cognitive Load Training

Intervention Description

10 low cognitive load sessions, 400 trials each

Primary Outcome Measure Information:

Title

Change in depressive rumination from baseline to the post-training assessment and follow-up (RRS)

Description

Assessed using the Ruminative Response Scale (RRS)

Time Frame

baseline, 2 weeks, 3 months

Title

Change in depressive symptomatology from baseline to the post-training assessment and follow-up (BDI-II)

Description

Assessed using the Beck Depression Inventory (BDI-II)

Time Frame

baseline, 2 weeks, 3 months

Secondary Outcome Measure Information:

Title

(mal-)Adaptive cognitive emotion regulation (CERQ)

Description

Assessed using the Cognitive Emotion Regulation Questionnaire (CERQ)

Time Frame

baseline, 2 weeks, 3 months

Title

Quality of Life (QLDS)

Description

Assessed using the Quality of Life in Depression Scale (QLDS)

Time Frame

baseline, 3 months

Title

Disability (WHODAS 2.0)

Description

Assessed using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

Time Frame

baseline, 3 months

Title

Resilience (RS)

Description

Assessed using the Resilience Scale (RS)

Time Frame

baseline, 3 months

Title

Remission from depression (RDQ)

Description

Assessed using the Remission of Depression Questionnaire (RDQ)

Time Frame

baseline, 3 months

Other Pre-specified Outcome Measures:

Title

Behavioral measure for cognitive control ((non-adaptive) PASAT)

Description

Assessed using the (non-adaptive) PASAT

Time Frame

baseline, 2 weeks, 3 months

Title

Self-reported cognitive control (BRIEF-A)

Description

Assessed using the Behaviour Rating Inventory of Executive Function Adult Version (BRIEF-A)

Time Frame

baseline, 2 weeks, 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

23 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: History of ≥ 1 depressive episode(s) Currently in stable full or partial remission (≥ 6 months) Exclusion Criteria: Major depressive disorder (MDD; current) Bipolar disorder (current and/or previous) Psychotic disorder (current and/or previous) Neurological impairments (current and/or previous) Excessive substance abuse (current and/or previous) No other comorbid disorders (current) No ongoing psychotherapeutic treatment (maintenance treatment is allowed, but with a frequency less than once / 3 weeks) Use of antidepressant medication is allowed if kept at a constant level

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ernst Koster, PhD

Organizational Affiliation

University Ghent

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ghent University

City

Ghent

State/Province

Oost-Vlaanderen

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

27362792

Citation

Hoorelbeke K, Koster EHW. Internet-delivered cognitive control training as a preventive intervention for remitted depressed patients: Evidence from a double-blind randomized controlled trial study. J Consult Clin Psychol. 2017 Feb;85(2):135-146. doi: 10.1037/ccp0000128. Epub 2016 Jun 30.

Results Reference

derived

PubMed Identifier

26055122

Citation

Hoorelbeke K, Faelens L, Behiels J, Koster EH. Internet-delivered cognitive control training as a preventive intervention for remitted depressed patients: Protocol for a randomized controlled trial. BMC Psychiatry. 2015 Jun 9;15:125. doi: 10.1186/s12888-015-0511-0.

Results Reference

derived

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Cognitive Control Training for Remitted Depressed Patients

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