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

Bipolar Affective Disorder Clinical Trial

— BAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00474357
• Other study ID #: LH55/2007.CTIL
• Status: Recruiting
• Phase: N/A
• First received: May 15, 2007
• Last updated: December 16, 2010
• Start date: May 2007
• Est. completion date: October 2008

Study information

• Verified date: May 2008
• Source: Lev-Hasharon Mental Healtlh Center
• Contact: Deby Peres, MD
• Phone: +972-9-8981242
• Email: debyp[@]lev-hasharon.co.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bipolar Affective Disorder
• Bipolar Disorder
• Genetic Diseases, X-Linked
• Mood Disorders

Intervention

Behavioral:
• Brief Structured Psychoeducation Group Therapy
weekly brief structured psychoeducation group therapy for seven weeks for bipolar patients

Locations

Country	Name	City	State
Israel	Lev Hasharon Mental Health Center	Netanya

Sponsors (1)

Lead Sponsor	Collaborator
Lev-Hasharon Mental Healtlh Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accepting Mental Illness Scale		7 weeks	No
Secondary	Hope Scale		7 weeks	No
Secondary	Myths about BAD questionnaire		7 weeks	No

External Links

•   Lev-Hasharon Mental Health Center