Bipolar Disorder, DepressedIPSRTNCT01037283
Interpersonal and Social Rhythm Therapy Enter the Brief Title for Protocol IRB 09-003781>
A study testing Interpersonal and Social Rhythm Therapy in people with Bipolar Disorder, Depressed, run by Mayo Clinic.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Depressed
- What is being tested?
- Interpersonal and Social Rhythm Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Adult patients with a confirmed diagnosis of Bipolar disorder in a depressed phase.
Referral for Interpersonal and Social Rhythm Therapy
About this study
Official title: 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.
- Conditions
- Bipolar Disorder, Depressed
- Being tested
- Interpersonal and Social Rhythm Therapy
- Keywords
- Bipolar, Depressed
- Medical subject headings
- Bipolar Disorder, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal and Social Rhythm TherapyBehavioural
Interpersonal and Social Rhythm Therapy delivered in two individual therapy sessions and six group therapy sessions.
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal and Social Rhythm Therapy | Other | All participants receive eight sessions of Interpersonal and Social Rhythm Therapy. Receives: Behavioral: Interpersonal and Social Rhythm Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom improvement and patient satisfaction with group and programmatic format in the delivery of interpersonal and social rhythm therapy.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionMay 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder, DepressedStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Astrid Hoberg, Mayo Clinic
- Investigators
- Astrid Hoberg, RN, CNS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037283
- Sponsor's protocol ID
- 09-003781
- Acronym
- IPSRT
- Status last verified
- Sep 2011
- First submitted
- 18 Dec 2009
- Last updated
- 16 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Interpersonal and Social Rhythm Therapy for Outpatients With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT01037283
- Acronym / sponsor ID
- IPSRT / 09-003781
- Conditions
- Bipolar Disorder, Depressed
- Keywords
- Bipolar, Depressed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interpersonal and Social Rhythm Therapy | Other | Behavioral: Interpersonal and Social Rhythm TherapyAll participants receive eight sessions of Interpersonal and Social Rhythm Therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpersonal and Social Rhythm TherapyInterpersonal and Social Rhythm Therapy delivered in two individual therapy sessions and six group therapy sessions. | Behavioural | Interpersonal and Social Rhythm Therapy |
Primary outcome
Symptom improvement and patient satisfaction with group and programmatic format in the delivery of interpersonal and social rhythm therapy.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Astrid Hoberg, RN, CNS principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal and Social Rhythm Therapy in people with Bipolar Disorder, Depressed, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom improvement and patient satisfaction with group and programmatic format in the delivery of interpersonal and social rhythm therapy. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2011.