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Pilot Study of Interpersonal and Social Rhythm Therapy for Subthreshold Bipolar

Primary Purpose

Bipolar Disorder NOS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interpersonal and social rhythm therapy
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  1. Adults age 18 - 65
  2. 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).
  3. Ability and willingness to give informed, written consent.
  4. 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.
  5. Ability and willingness to participate in study procedures

Exclusion Criteria:

  1. 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)
  2. 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
  3. 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
  4. Severe cognitive deficits that would preclude treatment with psychotherapy and/or prevent completion of study questionnaires
  5. 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.
  6. 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
  7. Prior lack of response to a trial of at least 12 weeks of IPSRT conducted by a qualified IPSRT therapist

Sites / Locations

  • Depression and Manic Depression Prevention Program

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Interpersonal and social rhythm therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
January 24, 2012
Last Updated
January 28, 2016
Sponsor
University of Pittsburgh
Collaborators
The Depressive and Bipolar Disorder Alternative Treatment Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01520129
Brief Title
Pilot Study of Interpersonal and Social Rhythm Therapy for Subthreshold Bipolar
Official Title
Pilot Study of Interpersonal and Social Rhythm Therapy for Subthreshold Bipolar
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
The Depressive and Bipolar Disorder Alternative Treatment Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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 hypomania, but the episodes of hypomania do not last long enough or are characterized by too few symptoms to meet conventional criteria for "threshold" hypomania. Compared to individuals with episodes of depression only (major depressive disorder or MDD), individuals with subthreshold BP have higher rates of suicide, earlier onset of illness, more episodes of depression, and more co-occurring psychiatric disorders. Despite the severity of the disorder, virtually nothing is known about how to treat this illness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder NOS
Keywords
Bipolar Disorder, Bipolar NOS, Bipolar Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interpersonal and social rhythm therapy
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Interpersonal and social rhythm therapy
Other Intervention Name(s)
IPSRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression severity
Description
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).
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly Swartz, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Depression and Manic Depression Prevention Program
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

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Pilot Study of Interpersonal and Social Rhythm Therapy for Subthreshold Bipolar

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