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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00330005
Other study ID # FFPR-001
Secondary ID
Status Completed
Phase N/A
First received May 24, 2006
Last updated May 24, 2006
Start date July 2002
Est. completion date January 2005

Study information

Verified date May 2006
Source The University of Texas Health Science Center at San Antonio
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study was to compare a group psychotherapy intervention, the Integrative Outpatient Model, to a convenience control, in adults with bipolar disorder.


Description:

The psychotherapy literature suggests that psychological treatments can have a significant impact on the clinical course and outcome for bipolar disorder (Swartz & Frank, 2001). Very few outcome studies have been conducted in group psychotherapy for bipolar disorder, and there are no preliminary studies conducted using the Integrative Outpatient Model, developed specifically for bipolar disorder. Given the lack of preliminary data, a pilot study with a matched-control design is indicated to obtain preliminary data regarding this treatment modality and approach. The IOM is a weekly, long term psychotherapy.

Comparison: Individuals who participate in group psychotherapy will be compared to a control group on mood and symptom ratings, up to 1 year post intervention.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date January 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:bipolar disorder; functioning level appropriate for outpatient group psychotherapy; willingness to engage in a psychotherapeutic intervention -

Exclusion Criteria: cognitive impairment; prominent psychosis; under 18 years old

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Group Psychotherapy


Locations

Country Name City State
United States University of Texas Health Science Center - Department of Psychiatry San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary depression symptoms
Primary manic symptoms
Primary number of days without a bipolar mood episode
Primary global assessment of functioning
Primary clinical global impression for bipolar disorder
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