The Effects of Cognitive Remediation on Cognitive Function in Remitted Bipolar Disorder - a Proof of Concept Study

Not Applicable

Completed

• Conditions: Bipolar Disorder
• Interventions: Other: Cognitive Remediation

• Registration Number: NCT01457235
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

Cognitive remediation (CR) is a new psychological treatment, which aims to improve cognitive function and coping skills. Several studies have recently demonstrated that CR improves cognitive and occupational function in patients with schizophrenia and with depression (e.g. Wykes et al 2007, Elgamal et al 2007). However, it is unclear whether CR improves cognitive and socio-occupational function in individuals with bipolar disorder (BD) and, if so, what impact this might have on these people's abilities in terms of work, coping strategies, quality of life, and everyday safety.

The aim of the present PhD study is to investigate if CR has beneficial effects on cognitive and socio-occupational function in patients with previous mania and depression who experience persistent cognitive difficulties. Such effects would suggest implementation of CR in future treatment of bipolar disorder in order to facilitate the patients' ability to cope with the responsibilities related to work and everyday life. The hypotheses of the present study are that CR (in comparison to standard treatment) will 1) improve verbal learning and recall; and 2) improve sustained attention, executive function and psychosocial function.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-10-10
• Study First Submitted QC: 2011-10-19
• Study First Posted: 2011-10-21
• Status Verified: 2014-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-01-29
• Last Update Posted: 2014-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Bipolar disorder in complete or partial remission (Hamilton Depression Rating Scale score of max 14 and Young Mania Scale score of max 14)
• Subjective complaints of moderate to severe cognitive problems on the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) (Fava et al 2006) (score at least 4 on at least 2 domains)

Exclusion Criteria

• Current ECT treatment
• Drug and/or alcohol abuse
• Schizophrenia
• Significant risk of suicide
• Use of benzodiazepines equivalent to more than 22,5 milligrams of Alopam

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Group	Cognitive Remediation	This group receives cognitive remediation in groups (each group consisting of 6-8 subjects)

Primary Outcome Measures

Name	Time	Method
Enhance verbal learning and memory as reflected by increase in Rey Auditory Verbal Learning Test (RAVLT) total learning scores and recall	Baseline and weeks 12 and 26	We expect a clinically relevant difference in the change between groups to be at least 4 points on RAVLT total scores.

Secondary Outcome Measures

Name	Time	Method
Improve sustained attention	Baseline and weeks 12 and 26	Increase total scores of sustained attention measured with the Rapid Visual Information Processing (RVP) test from baseline to post treatment (week 12)
Improve executive function	Baseline and weeks 12 and 26	Increase total scores of executive function measured with the Trail Making Test (TMT) part B from baseline to post treatment (week 12)
Increase psychosocial function	Baseline and weeks 12 and 26	Increase psychosocial function measured with Functional Assessment Short Test (FAST) total scores from baseline to post treatment (week 12)

Trial Locations

Locations (1)

Psychiatric Centre Copenhagen, Rigshospitalet, Denmark; 🇩🇰 Copenhagen, Denmark