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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
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder, Depressed focused on measuring Bipolar, Depressed

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 18, 2009
    Last Updated
    September 14, 2011
    Sponsor
    Mayo Clinic
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    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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