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

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ClinicalTrials.gov Identifier: NCT00474357
Recruitment Status : Unknown
Verified May 2008 by Lev-Hasharon Mental Healtlh Center.
Recruitment status was:  Recruiting
First Posted : May 16, 2007
Last Update Posted : December 17, 2010
Sponsor:
Information provided by:
Lev-Hasharon Mental Healtlh Center

Brief Summary:

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 or disease Intervention/treatment Phase
Bipolar Affective Disorder Behavioral: Brief Structured Psychoeducation Group Therapy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Myths About Bipolar Affective Disorder: The Role of Structured Group Psychoeducation Therapy
Study Start Date : May 2007
Estimated Primary Completion Date : October 2008
Estimated Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Accepting Mental Illness Scale [ Time Frame: 7 weeks ]

Secondary Outcome Measures :
  1. Hope Scale [ Time Frame: 7 weeks ]
  2. Myths about BAD questionnaire [ Time Frame: 7 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Additional Information:
Responsible Party: Dr. Deby Peres, Lev Hasharon Mental Health Center
ClinicalTrials.gov Identifier: NCT00474357     History of Changes
Other Study ID Numbers: LH55/2007.CTIL
First Posted: May 16, 2007    Key Record Dates
Last Update Posted: December 17, 2010
Last Verified: May 2008

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

Additional relevant MeSH terms:
Disease
Mood Disorders
Bipolar Disorder
Genetic Diseases, X-Linked
Pathologic Processes
Mental Disorders
Bipolar and Related Disorders
Genetic Diseases, Inborn