NCT01037283

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable

Status
completed

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

October 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 22, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

September 16, 2011

Status Verified

September 1, 2011

Enrollment Period

7 months

First QC Date

December 18, 2009

Last Update Submit

September 14, 2011

Conditions

Bipolar Disorder, Depressed

Keywords

BipolarDepressed

Outcome Measures

Primary Outcomes (1)

  • Symptom improvement and patient satisfaction with group and programmatic format in the delivery of interpersonal and social rhythm therapy.

    3 months

Study Arms (1)

Interpersonal and Social Rhythm Therapy

OTHER

All participants receive eight sessions of Interpersonal and Social Rhythm Therapy.

Behavioral: Interpersonal and Social Rhythm Therapy

Interventions

Interpersonal and Social Rhythm TherapyBEHAVIORAL

Interpersonal and Social Rhythm Therapy delivered in two individual therapy sessions and six group therapy sessions.

Interpersonal and Social Rhythm Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Adult patients with a confirmed diagnosis of Bipolar disorder in a depressed phase. Referral for Interpersonal and Social Rhythm Therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Bipolar DisorderConsciousness Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive Disorders

Study Officials

  • Astrid Hoberg, RN, CNS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Nurse Specialist

Study Record Dates

First Submitted

December 18, 2009

First Posted

December 22, 2009

Study Start

October 1, 2009

Primary Completion

May 1, 2010

Study Completion

August 1, 2010

Last Updated

September 16, 2011

Record last verified: 2011-09