Status:
COMPLETED
Pilot Study of Interpersonal and Social Rhythm Therapy for Subthreshold Bipolar
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
The Depressive and Bipolar Disorder Alternative Treatment Foundation
Conditions:
Bipolar Disorder NOS
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The investigators propose to conduct a 20 week open pilot study of Interpersonal and Social Rhythm Therapy (IPSRT) to treat individuals (n=18) with subthreshold bipolar (BP) who are currently depresse...
Detailed Description
Subthreshold bipolar disorder (BP) is a common, understudied, illness associated with high levels of impairment. "Subthreshold" BP refers to individuals who have episodes of both depression and hypoma...
Eligibility Criteria
Inclusion
- Adults age 18 - 65
- Meets criteria for bipolar disorder NOS, currently in an episode of major depression, as defined by the DSM-IV (American Psychiatric Association, 1994) and documented by the use of the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I), and by a rating of \>15 on the 25-item Hamilton Rating Scale for Depression (HRSD-25). We will limit inclusion specifically to those individuals who have histories of 1) at least one short (2-3 day) hypomanic episode OR 2) at least one subthreshold hypomanic episode (at least 4 consecutive days of elevated mood and 2 of the other symptoms of hypomania or irritable mood with 3 of the other symptoms of hypomania). NOTE: Like the National Comorbidity Survey Replication, individuals whose hypomania occurred while on antidepressant medication will not be excluded from the trial (Merikangas, personal communication, 2011).
- Ability and willingness to give informed, written consent.
- Subjects may participate in this study if they are currently taking psychotropic medications at time of informed consent. They will start study interventions if they still meet eligibility criteria after a one week wash-out period.
- Ability and willingness to participate in study procedures
Exclusion
- Severe or poorly controlled concurrent medical disorders that may cause confounding depressive symptoms (i.e., untreated hypothyroidism or lupus) or require medication(s) that could cause depressive symptoms (i.e., high doses of beta blockers or alpha interferon)
- Meets criteria for one of the following concurrent DSM-IV psychiatric disorders: any psychotic or organic mental disorder, bipolar I disorder, bipolar II disorder, current alcohol or drug dependence, primary obsessive compulsive disorder or primary eating disorders. (primary refers to the diagnosis associated with the most functional impairment); borderline personality disorder; antisocial personality disorder
- Acute suicidal or homicidal ideation or requiring psychiatric hospitalization. Subjects who require inpatient treatment will be excluded (or discontinued) from the study and referred to one of WPIC's inpatient mood disorder units, or, if preferred, to an inpatient facility nearer to the patient's home
- Severe cognitive deficits that would preclude treatment with psychotherapy and/or prevent completion of study questionnaires
- Non-fluent in English. Subjects must be able to speak and understand English because one of the study interventions, IPSRT, is an experimental talk-therapy. The DMDPP does not have multilingual therapists.
- Current participation in another form of individual psychotherapy. Concurrent participation in couples therapy, peer support groups (such as Alcoholics Anonymous), or family therapy will be permitted
- Prior lack of response to a trial of at least 12 weeks of IPSRT conducted by a qualified IPSRT therapist
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01520129
Start Date
March 1 2012
End Date
October 1 2014
Last Update
January 29 2016
Active Locations (1)
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1
Depression and Manic Depression Prevention Program
Pittsburgh, Pennsylvania, United States, 15213