Cognitive Control Training for Remitted Depressed Patients

Major Depression in Remission Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02407652
• Other study ID #: B/13808/01-CCT-003
• Status: Completed
• Phase: N/A
• First received: March 10, 2015
• Last updated: December 16, 2015
• Start date: December 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 23 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder, Major
• Major Depression in Remission

Intervention

Behavioral:
• Cognitive Control Training
10 adaptive Paced Auditory Serial Addition Task (PASAT) sessions, 400 trials each
• Low Cognitive Load Training
10 low cognitive load sessions, 400 trials each

Locations

Country	Name	City	State
Belgium	Ghent University	Ghent	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	Behavioral measure for cognitive control ((non-adaptive) PASAT)	Assessed using the (non-adaptive) PASAT	baseline, 2 weeks, 3 months	No
Other	Self-reported cognitive control (BRIEF-A)	Assessed using the Behaviour Rating Inventory of Executive Function Adult Version (BRIEF-A)	baseline, 2 weeks, 3 months	No
Primary	Change in depressive rumination from baseline to the post-training assessment and follow-up (RRS)	Assessed using the Ruminative Response Scale (RRS)	baseline, 2 weeks, 3 months	No
Primary	Change in depressive symptomatology from baseline to the post-training assessment and follow-up (BDI-II)	Assessed using the Beck Depression Inventory (BDI-II)	baseline, 2 weeks, 3 months	No
Secondary	(mal-)Adaptive cognitive emotion regulation (CERQ)	Assessed using the Cognitive Emotion Regulation Questionnaire (CERQ)	baseline, 2 weeks, 3 months	No
Secondary	Quality of Life (QLDS)	Assessed using the Quality of Life in Depression Scale (QLDS)	baseline, 3 months	No
Secondary	Disability (WHODAS 2.0)	Assessed using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)	baseline, 3 months	No
Secondary	Resilience (RS)	Assessed using the Resilience Scale (RS)	baseline, 3 months	No
Secondary	Remission from depression (RDQ)	Assessed using the Remission of Depression Questionnaire (RDQ)	baseline, 3 months	No