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

This study has been completed.
Sponsor:
Collaborators:
TrygFonden, Denmark
Copenhagen University Hospital, Hvidovre
Information provided by (Responsible Party):
Kamilla Miskowiak, Psychiatric Centre Rigshospitalet
ClinicalTrials.gov Identifier:
NCT01457235
First received: October 10, 2011
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Bipolar Disorder
Other: Cognitive Remediation

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Enrollment: 46
Study Start Date: August 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01457235

Locations
Denmark
Psychiatric Centre Copenhagen, Rigshospitalet, Denmark
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
TrygFonden, Denmark
Copenhagen University Hospital, Hvidovre
Investigators
Principal Investigator: Kamilla W Miskowiak, Dr Psychiatric Centre Copenhagen, Rigshospitalet, Denmark
  More Information

No publications provided by Rigshospitalet, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kamilla Miskowiak, Psychologist, Dr., Psychiatric Centre Rigshospitalet
ClinicalTrials.gov Identifier: NCT01457235     History of Changes
Other Study ID Numbers: H-1-2010-039
Study First Received: October 10, 2011
Last Updated: January 29, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:
Bipolar disorder
Cognitive Remediation
Cognition
Cognitive function
Mood disorders
Affective disorders

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014