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Cognitive-Behavioral Rehabilitation for Bipolar Disorder (REHABBipolar)

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ClinicalTrials.gov Identifier: NCT02766361
Recruitment Status : Recruiting
First Posted : May 9, 2016
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Bernardo Carramão Gomes, University of Sao Paulo

Brief Summary:
The study consists of a clinical trial comparing a new structured group intervention, denominated "Cognitive-Behavioral Rehabilitation", to treatment as usual (TAU) for bipolar patients. The new approach is a combination of cognitive behavioral strategies and cognitive rehabilitation exercises, consisting of twelve weekly group sessions of 90 minutes each. To be included in the study, patients must be diagnosed with bipolar disorder, type I or II, be 18 to 55 years old, in full or partial remission and have an IQ of at least 80. A comprehensive neuropsychological battery, followed by mood, social functioning and quality of life assessments will occur in three moments: pre and post-intervention and after 12 months.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Behavioral: Cognitive Behavioral Rehabilitation Other: Treatment as Usual Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Cognitive-Behavioral Rehabilitation Versus Treatment as Usual for Bipolar Patients
Study Start Date : March 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive Behavioral Rehabilitation
12 sessions of new intervention of cognitive behavior therapy and cognitive rehabilitation
Behavioral: Cognitive Behavioral Rehabilitation
12 weekly sessions of Combined intervention lasting 90 minutes
Other Name: Combined intervention of CBT and Cognitive Rehabilitation

Active Comparator: Treatment as Usual
standard out-patient treatment offered in our clinic, which involves psychopharmacological mood stabilization and regular contacts with mental health nurses.
Other: Treatment as Usual
standard out-patient treatment offered in our clinic, which involves psychopharmacological mood stabilization and regular contacts with mental health nurses.




Primary Outcome Measures :
  1. Interval to first mood episode [ Time Frame: 6 months after the beginning of intervention group ]
    Survival data


Secondary Outcome Measures :
  1. Change in Quality of life scores score WHOQOL [ Time Frame: 3, 6 and 12 months after the beginning of intervention group ]
  2. Change in Functionality Scale for Bipolar disorder (FAST) [ Time Frame: 3, 6 and 12 months after the beginning of intervention group ]
  3. Change in Barratt Impulsivity scale (BIS) [ Time Frame: 3, 6 and 12 months after the beginning of intervention group ]
  4. Change in Brian Sleep Scale [ Time Frame: 3, 6 and 12 months after the beginning of intervention group ]
  5. Change in Social skills scale (IHS) [ Time Frame: 3, 6 and 12 months after the beginning of intervention group ]
  6. Change in Motor Screening Task [ Time Frame: 3, 6 and 12 months after the beginning of intervention group ]
    CANTAB SUBTEST

  7. Change in Rapid Visual Information Processing [ Time Frame: 3, 6 and 12 months after the beginning of intervention group ]
    CANTAB SUBTEST

  8. Change in Reaction time Time Reaction time [ Time Frame: 3, 6 and 12 months after the beginning of intervention group ]
    CANTAB SUBTEST

  9. Change in Spatial Span [ Time Frame: 3, 6 and 12 months after the beginning of intervention group ]
    CANTAB SUBTEST

  10. Change in Spatial Working Memory [ Time Frame: 3, 6 and 12 months after the beginning of intervention group ]
    CANTAB SUBTEST

  11. Change in One Touch Stockings of Cambridge Change in Stockings of Cambridge [ Time Frame: 3, 6 and 12 months after the beginning of intervention group ]
    CANTAB SUBTEST

  12. Change in Pattern Recognition Memory [ Time Frame: 3, 6 and 12 months after the beginning of intervention group ]
    CANTAB SUBTEST

  13. Change in Delayed Change in Delayed Matching to Sample [ Time Frame: 3, 6 and 12 months after the beginning of intervention group ]
    CANTAB SUBTEST

  14. Change in Attention Switching Task [ Time Frame: 3, 6 and 12 months after the beginning of intervention group ]
    CANTAB SUBTEST

  15. Emotion Recognition Change in Emotion Recognition Task [ Time Frame: 3, 6 and 12 months after the beginning of intervention group ]
    CANTAB SUBTEST


Other Outcome Measures:
  1. Change in YMRS [ Time Frame: 3, 6 and 12 months after the beginning of intervention group ]
    Young Mania Rating Scale

  2. Change in MADRS [ Time Frame: 3, 6 and 12 months after the beginning of intervention group ]
    Montgomery-Åsberg Depression Rating Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • IQ higher than 80
  • Bipolar I or II diagnoses
  • Being literate

Exclusion Criteria:

  • substance or alcohol abuse in the last 6 months,
  • current suicide risk,
  • organic mental disorders
  • scores higher than 12, in the Montgomery-Åsberg Depression Rating Scale (MADRS) or the Young Mania Rating Scale (YMRS) at the beginning of the interventions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766361


Contacts
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Contact: Bernardo C Gomes, M.Sc 55 11 2661-7928 bernardocarramao@gmail.com
Contact: Cristiana C Rocca, PhD 55 11 2661-7928 crisrocca@gmail.com

Locations
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Brazil
Bipolar Disorder Program (PROMAN), Department of Psychiatry Recruiting
São Paulo, Brazil, 05372100
Contact: Bernardo C Gomes, M. Sc    55 11 2661-7928    bernardocarramao@gmail.com   
Sponsors and Collaborators
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Principal Investigator: Beny Lafer, Professor University of São Paulo Medical School, São Paulo, Brazil

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bernardo Carramão Gomes, PhD Student, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02766361     History of Changes
Other Study ID Numbers: CNPQ 458144/2014-2
First Posted: May 9, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Bernardo Carramão Gomes, University of Sao Paulo:
Bipolar disorder
Psychotherapy
Cognitive rehabilitation

Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders