NCT00474357

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

December 17, 2010

Status Verified

May 1, 2008

Enrollment Period

1.4 years

First QC Date

May 15, 2007

Last Update Submit

December 16, 2010

Conditions

Keywords

Bipolar affective disordermythspreconceived notionsstigmahope

Outcome Measures

Primary Outcomes (1)

  • Accepting Mental Illness Scale

    7 weeks

Secondary Outcomes (2)

  • Hope Scale

    7 weeks

  • Myths about BAD questionnaire

    7 weeks

Study Arms (3)

1

EXPERIMENTAL

Bipolar patients participating in psychoeducation intervention

Behavioral: Brief Structured Psychoeducation Group Therapy

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

Interventions

weekly brief structured psychoeducation group therapy for seven weeks for bipolar patients

1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DSM-IV diagnosis of BAD
  • State of remission

You may not qualify if:

  • HAM-D score \< 10
  • YMRS score \< 12
  • Has a guardian for either self or property

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lev Hasharon Mental Health Center

Netanya, 42100, Israel

RECRUITING

Related Links

MeSH Terms

Conditions

Bipolar DisorderSocial Stigma

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersSocial BehaviorBehavior

Study Officials

  • Igor Oyffe, MD

    Lev HaSharon Mental Health Center

    STUDY DIRECTOR
  • Deby Peres, MD

    Lev HaSharon Mental Health Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 15, 2007

First Posted

May 16, 2007

Study Start

May 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

December 17, 2010

Record last verified: 2008-05

Locations