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

Primary Purpose

Bipolar Affective Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Brief Structured Psychoeducation Group Therapy
Sponsored by
Lev-Hasharon Mental Healtlh Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bipolar Affective Disorder focused on measuring Bipolar affective disorder, myths, preconceived notions, stigma, hope

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lev Hasharon Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

1

2

3

Arm Description

Bipolar patients participating in psychoeducation intervention

bipolar patients who do not participate in psychoeducation group

Therapists will complete questionnaires regarding myths about bipolar patients, no intervention

Outcomes

Primary Outcome Measures

Accepting Mental Illness Scale

Secondary Outcome Measures

Hope Scale
Myths about BAD questionnaire

Full Information

First Posted
May 15, 2007
Last Updated
December 16, 2010
Sponsor
Lev-Hasharon Mental Healtlh Center
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1. Study Identification

Unique Protocol Identification Number
NCT00474357
Brief Title
Myths About Bipolar Affective Disorder: The Role of Structured Group Psychoeducation Therapy
Acronym
BAD
Official Title
Myths About Bipolar Affective Disorder: The Role of Structured Group Psychoeducation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
October 2008 (Anticipated)
Study Completion Date
October 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Lev-Hasharon Mental Healtlh Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Affective Disorder
Keywords
Bipolar affective disorder, myths, preconceived notions, stigma, hope

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Bipolar patients participating in psychoeducation intervention
Arm Title
2
Arm Type
No Intervention
Arm Description
bipolar patients who do not participate in psychoeducation group
Arm Title
3
Arm Type
No Intervention
Arm Description
Therapists will complete questionnaires regarding myths about bipolar patients, no intervention
Intervention Type
Behavioral
Intervention Name(s)
Brief Structured Psychoeducation Group Therapy
Intervention Description
weekly brief structured psychoeducation group therapy for seven weeks for bipolar patients
Primary Outcome Measure Information:
Title
Accepting Mental Illness Scale
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Hope Scale
Time Frame
7 weeks
Title
Myths about BAD questionnaire
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deby Peres, MD
Phone
+972-9-8981242
Ext
242
Email
debyp@lev-hasharon.co.il
First Name & Middle Initial & Last Name or Official Title & Degree
Igor Oyffe, MD
Phone
+972-9-8981248
Ext
248
Email
igoro@lev-hasharon.co.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Igor Oyffe, MD
Organizational Affiliation
Lev HaSharon Mental Health Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Deby Peres, MD
Organizational Affiliation
Lev HaSharon Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lev Hasharon Mental Health Center
City
Netanya
ZIP/Postal Code
42100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deby Peres, MD
Phone
+972-9-8981242
Ext
242
Email
debyp@lev-hasharon.co.il
First Name & Middle Initial & Last Name & Degree
Igor Oyffe, MD
Phone
+972-9-8981248
Ext
248
Email
igoro@lev-hasharon.co.il
First Name & Middle Initial & Last Name & Degree
Deby Peres, MD
First Name & Middle Initial & Last Name & Degree
Igor Oyffe, MD
First Name & Middle Initial & Last Name & Degree
Amit Levin, MA
First Name & Middle Initial & Last Name & Degree
David Azikri, PhD

12. IPD Sharing Statement

Links:
URL
http://www.lev-hasharon.co.il
Description
Lev-Hasharon Mental Health Center

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

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