Interpersonal and Social Rhythm Therapy Enter the Brief Title for Protocol IRB 09-003781> (IPSRT)
Primary Purpose
Bipolar Disorder, Depressed
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interpersonal and Social Rhythm Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder, Depressed focused on measuring Bipolar, Depressed
Eligibility Criteria
Adult patients with a confirmed diagnosis of Bipolar disorder in a depressed phase.
Referral for Interpersonal and Social Rhythm Therapy
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Interpersonal and Social Rhythm Therapy
Arm Description
All participants receive eight sessions of Interpersonal and Social Rhythm Therapy.
Outcomes
Primary Outcome Measures
Symptom improvement and patient satisfaction with group and programmatic format in the delivery of interpersonal and social rhythm therapy.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01037283
Brief Title
Interpersonal and Social Rhythm Therapy Enter the Brief Title for Protocol IRB 09-003781>
Acronym
IPSRT
Official Title
Feasibility of Interpersonal and Social Rhythm Therapy for Outpatients With Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In patients with bipolar disorder referred for psychotherapy, is interpersonal and social rhythm therapy delivered in a group psychotherapy format over 2-3 weeks feasible? This project will help determine if interpersonal social rhythm therapy can be delivered in the programmatic format being considered for the outpatient mood program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Depressed
Keywords
Bipolar, Depressed
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interpersonal and Social Rhythm Therapy
Arm Type
Other
Arm Description
All participants receive eight sessions of Interpersonal and Social Rhythm Therapy.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal and Social Rhythm Therapy
Intervention Description
Interpersonal and Social Rhythm Therapy delivered in two individual therapy sessions and six group therapy sessions.
Primary Outcome Measure Information:
Title
Symptom improvement and patient satisfaction with group and programmatic format in the delivery of interpersonal and social rhythm therapy.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Adult patients with a confirmed diagnosis of Bipolar disorder in a depressed phase.
Referral for Interpersonal and Social Rhythm Therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astrid Hoberg, RN, CNS
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Interpersonal and Social Rhythm Therapy Enter the Brief Title for Protocol IRB 09-003781>
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