The Effects of Cognitive Remediation on Cognitive Function in Remitted Bipolar Disorder - a Proof of Concept Study (REMEDI)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||The Effects of Cognitive Remediation on Cognitive Function in Remitted Bipolar Disorder - a Proof of Concept Study (REMEDI)|
- Enhance verbal learning and memory as reflected by increase in Rey Auditory Verbal Learning Test (RAVLT) total learning scores and recall [ Time Frame: Baseline and weeks 12 and 26 ] [ Designated as safety issue: No ]We expect a clinically relevant difference in the change between groups to be at least 4 points on RAVLT total scores.
- Improve sustained attention [ Time Frame: Baseline and weeks 12 and 26 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and weeks 12 and 26 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and weeks 12 and 26 ] [ Designated as safety issue: No ]Increase psychosocial function measured with Functional Assessment Short Test (FAST) total scores from baseline to post treatment (week 12)
|Study Start Date:||August 2011|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Active Group
This group receives cognitive remediation in groups (each group consisting of 6-8 subjects)
Other: Cognitive Remediation
All subjects will complete an MR brain scan, blood test, saliva test, and a neuropsychological battery of manual and computerised tests at baseline, at week 12 (end of active treatment) and week 26 (follow-up). Subjects randomly allocated to an active group will participate in a 12-week group-based cognitive remediation programme once a week for two hours. The waiting list group continues treatment as usual.
No Intervention: Waiting List
Patients randomized to the waiting list group continues standard treatment and will be offered a course of cognitive remediation upon completion of participation provided that they still meet the inclusion criteria.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01457235
|Psychiatric Centre Copenhagen, Rigshospitalet, Denmark|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Kamilla W Miskowiak, Dr||Psychiatric Centre Copenhagen, Rigshospitalet, Denmark|