Myths About Bipolar Affective Disorder: The Role of Structured Group Psychoeducation Therapy - Full Text View

Sponsored by:	Lev-Hasharon Mental Healtlh Center
Information provided by:	Lev-Hasharon Mental Healtlh Center
ClinicalTrials.gov Identifier:	NCT00474357

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, psychiatric nurses.

The investigators hypothesize that psycho education group therapy will be effective in refuting the myths and will lead to better treatment adherence, longer remissions, less 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

MedlinePlus related topics: Bipolar Disorder Mental Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Myths About Bipolar Affective Disorder: The Role of Structured Group Psychoeducation Therapy

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
1: Experimental Bipolar patients participating in psychoeducation intervention	Behavioral: Brief Structured Psychoeducation Group Therapy weekly brief structured psychoeducation group therapy for seven weeks for bipolar patients
2: No Intervention bipolar patients who do not participate in psychoeducation group
3: No Intervention Therapists will complete questionnaires regarding myths about bipolar patients, no intervention

Detailed Description:

Methods:

Effect psycho education:

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 psycho education 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:	Lev Hasharon Mental Health Center ( Dr. Deby Peres )
Study ID Numbers:	LH55/2007.CTIL
Study First Received:	May 15, 2007
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00474357 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Lev-Hasharon Mental Healtlh Center:

Bipolar affective disorder
myths
preconceived notions
stigma
hope

Study placed in the following topic categories:

Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Mood Disorders
Psychotic Disorders

Additional relevant MeSH terms:

Affective Disorders, Psychotic
Pathologic Processes
Disease

Mental Disorders
Bipolar Disorder
Mood Disorders

ClinicalTrials.gov processed this record on May 07, 2009