Pilot Study of Interpersonal and Social Rhythm Therapy for Subthreshold Bipolar

NCT01520129 | Completed

• 1 other identifier: PRO11110666
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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 depressed. The investigators will conduct a preliminary evaluation of sleep-wake and social rhythm patterns in study participants using questionnaires and actigraphy. Primary aims of this study are to evaluate feasibility of this treatment and assessment approach. Exploratory aims are to examine 1) sleep-wake and social rhythm patterns in subthreshold BP, 2) impact of IPSRT on symptoms and functioning over time and 3) relationship between sleep-wake and social rhythm patterns and treatment outcomes.

Conditions

Bipolar Disorder NOS

Keywords

Bipolar Disorder; Bipolar NOS; Bipolar Depression

Outcome Measures

Primary Outcomes (1)

• Depression severity

  The primary endpoint is depression severity at week 20, which will be measured via the Hamilton Rating Scale for Depression 25-item score (HRSD-25) and the Young Mania Rating Scale (YMRS).

  20 weeks

Study Arms (1)

Interpersonal and social rhythm therapy

OTHER

IPSRT Subjects will receive weekly 45 minute sessions of IPSRT for 20 weeks. IPSRT sessions focus on reducing symptoms by teaching patients to: a) increase regularity of social rhythms and regulate sleep-wake cycles; b) resolve interpersonal problems that contribute to mood symptoms (role dispute, role transition, grief, or interpersonal deficits); and c) recognize and accept the symptoms of subthreshold BP disorder (psychoeducation). Although we train therapists in techniques that are specific to each component, in practice, these strategies are administered flexibly and fluidly, without distinct boundaries between modalities. During the course of a session, therapists move seamlessly among the techniques, according to patients' needs.

Other: Interpersonal and social rhythm therapy

Interventions

Interpersonal and social rhythm therapy OTHER

IPSRT Subjects will receive weekly 45 minute sessions of IPSRT for 20 weeks. IPSRT sessions focus on reducing symptoms by teaching patients to: a) increase regularity of social rhythms and regulate sleep-wake cycles; b) resolve interpersonal problems that contribute to mood symptoms (role dispute, role transition, grief, or interpersonal deficits); and c) recognize and accept the symptoms of subthreshold BP disorder (psychoeducation). Although we train therapists in techniques that are specific to each component, in practice, these strategies are administered flexibly and fluidly, without distinct boundaries between modalities. During the course of a session, therapists move seamlessly among the techniques, according to patients' needs.

Also known as: IPSRT

Interpersonal and social rhythm therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 18 - 65
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• The Depressive and Bipolar Disorder Alternative Treatment Foundation: collaborator

Study Sites (1)

Depression and Manic Depression Prevention Program

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Holly Swartz, MD

  University of Pittsburgh

  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: Professor of Psychiatry

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 27, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 29, 2016

Record last verified: 2016-01

Locations

US (1)