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Myths About Bipolar Affective Disorder: The Role of Structured Group Psychoeducation Therapy (BAD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Lev-Hasharon Mental Healtlh Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lev-Hasharon Mental Healtlh Center
ClinicalTrials.gov Identifier:
NCT00474357
First received: May 15, 2007
Last updated: December 16, 2010
Last verified: May 2008
History of Changes
  Purpose

This study will examine:

1) The impact of psycho education group therapy sessions relating to beliefs/myths associated with bipolar affective disorder (BAD) on the emotional wellbeing, clinical course and cognition of individuals diagnosed with BAD 2) Will examine the existence of those same beliefs among the various caregivers - psychiatrists, general practitioners, social workers, and psychiatric nurses.

The investigators hypothesize that psychoeducation group therapy will be effective in refuting the myths and will lead to better treatment adherence, longer remissions, fewer hospitalizations, improved self esteem, increased optimism, and better control over the disease process. The investigators also believe that they will identify some beliefs/myths or preconceived notions that are common to both caregivers and individuals with BAD.


Condition Intervention
Bipolar Affective Disorder
 Behavioral: Brief Structured Psychoeducation Group Therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Myths About Bipolar Affective Disorder: The Role of Structured Group Psychoeducation Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lev-Hasharon Mental Healtlh Center:

Primary Outcome Measures:
  • Accepting Mental Illness Scale [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hope Scale [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Myths about BAD questionnaire [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: May 2007
Estimated Study Completion Date: October 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bipolar patients participating in psychoeducation intervention
 Behavioral: Brief Structured Psychoeducation Group Therapy
weekly brief structured psychoeducation group therapy for seven weeks for bipolar patients
No Intervention: 2
bipolar patients who do not participate in psychoeducation group
No Intervention: 3
Therapists will complete questionnaires regarding myths about bipolar patients, no intervention

Detailed Description:

Methods:

Effect psychoeducation:

Study population - 30 patients diagnosed with BAD treated in the outpatient clinic, in a state of remission will be evaluated with the Hamilton Rating Scale for Depression, Young Mania Rating Scale, and will then participate in 7 weekly sessions of brief structured psycho education therapy Control group - 30 patients diagnosed with BAD treated in the outpatient clinic, in a state of remission will be evaluated with the Hamilton Rating Scale for Depression, Young Mania Rating Scale. In addition both groups will complete the Snyder Hope Scale, Accepting the Mental Illness Label Scale and a questionnaire regarding Myths in BAD prior to the study, and when the study group finishes their group therapy sessions. (Controls will not participate in the psychoeducation group therapy).

Caregivers beliefs:

50 caregivers from various professions will complete the questionnaire regarding the myths, once only.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • DSM-IV diagnosis of BAD
  • State of remission

Exclusion Criteria:

  • HAM-D score < 10
  • YMRS score < 12
  • Has a guardian for either self or property
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00474357

Contacts
Contact: Deby Peres, MD +972-9-8981242 ext 242 debyp@lev-hasharon.co.il
Contact: Igor Oyffe, MD +972-9-8981248 ext 248 igoro@lev-hasharon.co.il

Locations
Israel
Lev Hasharon Mental Health Center Recruiting
Netanya, Israel, 42100
Contact: Deby Peres, MD     +972-9-8981242 ext 242     debyp@lev-hasharon.co.il    
Contact: Igor Oyffe, MD     +972-9-8981248 ext 248     igoro@lev-hasharon.co.il    
Principal Investigator: Deby Peres, MD            
Principal Investigator: Igor Oyffe, MD            
Sub-Investigator: Amit Levin, MA            
Sub-Investigator: David Azikri, PhD            
Sponsors and Collaborators
Lev-Hasharon Mental Healtlh Center
Investigators
Study Director: Igor Oyffe, MD Lev-Hasharon Mental Health Center
Principal Investigator: Deby Peres, MD Lev-Hasharon Mental Health Center
  More Information

Additional Information:
Lev-Hasharon Mental Health Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr. Deby Peres, Lev Hasharon Mental Health Center
ClinicalTrials.gov Identifier: NCT00474357     History of Changes
Other Study ID Numbers: LH55/2007.CTIL
Study First Received: May 15, 2007
Last Updated: December 16, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Lev-Hasharon Mental Healtlh Center:
Bipolar affective disorder
myths
preconceived notions
stigma
hope

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

ClinicalTrials.gov processed this record on May 19, 2013