Online Cognitive Control Training for Remitted Depressed Patients

Major Depression in Remission Clinical Trial

Official title:

Online Cognitive Control Training for Remitted Depressed Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03278756
• Other study ID #: B/14730/RMD
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: March 13, 2019

Study information

• Verified date: November 2022
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 13, 2019
• Est. primary completion date: March 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Major Depression in Remission

Intervention

Behavioral:
• Cognitive control training
10 sessions of an adaptive paced auditory serial addition task, each lasting 15 minutes, over the course of two weeks.
• Active control training
10 sessions of an low cognitive load task, each lasting 15 minutes, over the course of two weeks.

Locations

Country	Name	City	State
Belgium	Ghent University	Gent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	User engagement	Measured by the User Engagement Scale (UES)	Assessed at post-training assessment (within 1 week of completing the training) and at 3 months follow-up
Other	Threatening experiences	Measured by the List of Threatening Experiences (LTE)	Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Other	Effortful control	Measured by the subscale Effortful Control (EC) from the Adult Temperament Questionnaire (ATQ)	Assessed at pre-training assessment and at 6 months follow-up
Other	Credibility and Expectancy	Measured by the Credibility/Expectancy Questionnaire	Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Other	Behavioral measure for cognitive control	Measured by the non-adaptive Paced Auditory Serial Addition Task (PASAT)	Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Primary	Change in depressive symptomatology	Measured by the Beck Depression Inventory - II (BDI-II)	Assessed at pre-training assessment and at 6 months follow-up
Primary	Change in depressive symptomatology	Measured by the Depression Anxiety Stress Scales (DASS)	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
Primary	Change in depressive rumination (brooding)	Measured by the Ruminative Response Scale (RRS), especially the brooding subscale	Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Secondary	Change in cognitive emotion regulation strategies	Measured by the Cognitive Emotion Regulation Questionnaire (CERQ)	Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Secondary	Change in quality of life	Measured by the Quality of Life in Depression Scale (QLDS)	Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Secondary	Remission from depression	Measured by the Remission of Depression Questionnaire (RDQ)	Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up
Secondary	Resilience	Measured by the Connor-Davidson Resilience Scale (CD-RISC)	Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up