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

This study is currently recruiting participants.
Verified November 2011 by Rigshospitalet, Denmark
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: November 14, 2011
Last verified: November 2011
History of Changes
  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 usual medical treatment) will: 1) improve memory, executive function, and social and occupational function; and 2) increase neuroplasticity and reduce somatic stress.


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 Remitted Bipolar Disorder - a Proof of Concept Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Change in total memory scores on the Rey Auditory Verbal Learning Test after treatment [ Time Frame: Baseline and weeks 12 and 26 ] [ Designated as safety issue: No ]
    Clinical difference between the two groups on total memory scores on the Rey Auditory Verbal Learning Test


Secondary Outcome Measures:
  • Total psychosocial function scores on Functional Assessment Short Test (FAST) [ Time Frame: Baseline and weeks 12 and 26 ] [ Designated as safety issue: No ]
    Clinical difference between the two groups on total scores on psychosocial function measured with (FAST)

  • Total scores of concentration and planning skills and emotional processing [ Time Frame: Baseline and weeks 12 and 26 ] [ Designated as safety issue: No ]
    Total scores of concentration and planning skills and emotional processing measured with 1) MR brain scans; 2) questionnaires; and 3) manual and computerised neuropsychological tests (Danish Adult Reading Test; Rey Auditory Verbal Learning Test, Repetable Battery of the Assessment of Neuropsychological Status digit span and coding; Word Association, WAIS-III Letter-Number Sequencing, Trail making A and B; and the following computerised tests from Cambridge Cognition (CANTAB): Rapid Visual Information Processing; Delayed Match-to-Sample; and Spatial Working Memory).

  • Clinical difference between the two groups on increased neuroplasticity and reduced somatic stress [ Time Frame: Baseline and weeks 12 and 26 ] [ Designated as safety issue: No ]
    Clinical difference between the two groups on increased neuroplasticity and reduced somatic stress measured with plasma/serum/full blood brain-derived neurotrophic factor (BDNF ) and reduced morning awakening cortisol, respectively.


Estimated Enrollment: 40
Study Start Date: August 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (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
The waiting list group continues treatment as usual (each group consisting of 6-8 subjects). Once each active group has been compared to a waiting list group the latter is offered cognitive remediation in groups as well
 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.

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

Contacts
Contact: Kirsa M Demant, Psychologist +45 3545 6257 kirsa.moerkeberg.demant@regionh.dk
Contact: Kamilla W Miskowiak, Dr +45 3545 7425 kamilla.miskowiak@regionh.dk

Locations
Denmark
Psychiatric Centre Copenhagen, Rigshospitalet, Denmark Recruiting
Copenhagen, Denmark, 2100
Contact: Kirsa M Demant, Psychologist     +45 3545 6257     kirsa.moerkeberg.demant@regionh.dk    
Contact: Kamilla W Miskowiak, Dr     +45 3545 7425     kamilla.miskowiak@regionh.dk    
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

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: November 14, 2011
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 June 18, 2013