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

December 16, 2010 updated by: Lev-Hasharon Mental Healtlh Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Netanya, Israel, 42100
        • Recruiting
        • Lev Hasharon Mental Health Center
        • Principal Investigator:
          • Igor Oyffe, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Deby Peres, MD
        • Sub-Investigator:
          • Amit Levin, MA
        • Sub-Investigator:
          • David Azikri, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accepting Mental Illness Scale
Time Frame: 7 weeks
7 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Hope Scale
Time Frame: 7 weeks
7 weeks
Myths about BAD questionnaire
Time Frame: 7 weeks
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Anticipated)

October 1, 2008

Study Completion (Anticipated)

October 1, 2008

Study Registration Dates

First Submitted

May 15, 2007

First Submitted That Met QC Criteria

May 15, 2007

First Posted (Estimate)

May 16, 2007

Study Record Updates

Last Update Posted (Estimate)

December 17, 2010

Last Update Submitted That Met QC Criteria

December 16, 2010

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LH55/2007.CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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