- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01037283
Interpersonal and Social Rhythm Therapy Enter the Brief Title for Protocol IRB 09-003781> (IPSRT)
September 14, 2011 updated by: Astrid Hoberg, Mayo Clinic
Feasibility of Interpersonal and Social Rhythm Therapy for Outpatients With Bipolar Disorder
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Adult patients with a confirmed diagnosis of Bipolar disorder in a depressed phase.
Referral for Interpersonal and Social Rhythm Therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Interpersonal and Social Rhythm Therapy
All participants receive eight sessions of Interpersonal and Social Rhythm Therapy.
|
Interpersonal and Social Rhythm Therapy delivered in two individual therapy sessions and six group therapy sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Symptom improvement and patient satisfaction with group and programmatic format in the delivery of interpersonal and social rhythm therapy.
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Astrid Hoberg, RN, CNS, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
December 18, 2009
First Submitted That Met QC Criteria
December 18, 2009
First Posted (Estimate)
December 22, 2009
Study Record Updates
Last Update Posted (Estimate)
September 16, 2011
Last Update Submitted That Met QC Criteria
September 14, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-003781
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.