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Interpersonal and Social Rhythm Therapy for Adolescents With Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interpersonal and Social Rhythm Therapy for Adolescents (IPSRT-A)
Treatment As Usual (TAU)
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Adolescent, Psychopathology, Interpersonal Therapy, Interpersonal and Social Rhythm Therapy

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • DSM-IV diagnosis of bipolar spectrum disorder: type I, type II, or NOS
  • Currently meets DSM-IV criteria for a depressed, manic, hypomanic, or mixed episode
  • Youth assent/parental consent to outpatient psychotherapy for treatment of bipolar disorder
  • Adequate access to transportation or close proximity in order to participate in therapy

Exclusion Criteria:

  • DSM-IV diagnosis of schizophrenia, schizophreniform, or schizoaffective disorders
  • Developmentally delayed
  • Actively psychotic, suicidal, homicidal, or engages in repeated parasuicidal behaviors
  • History of chronic suicidality (e.g., more than three suicidal gestures in the year prior to study entry)
  • Neurological or other medical disorder that could potentially cause or complicate presenting psychiatric symptoms
  • Meets current DSM-IV criteria for drug or alcohol abuse or dependence
  • Life circumstances that would prohibit ability to participate, including absence of shelter or impending jail/prison for more than 2 weeks during study
  • Parent/legal guardian refusal to participate with the adolescent

Sites / Locations

  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

2

1

Arm Description

Participants will receive treatment as usual

Participants will receive interpersonal and social rhythm therapy for adolescents

Outcomes

Primary Outcome Measures

Brief Psychiatric Rating Scale for Children

Secondary Outcome Measures

Mania Rating Scale (MRS), Beck Depression Inventory (BDI),Child Behavior Checklist (CBCL), Youth Self-Report Form (YSR), Social Adjustment Scale for Adolescents (SAS-SR-A), Conflict Behavior Questionnaire (CBQ)

Full Information

First Posted
December 17, 2007
Last Updated
June 19, 2012
Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00576355
Brief Title
Interpersonal and Social Rhythm Therapy for Adolescents With Bipolar Disorder
Official Title
Adjunctive Psychotherapy for Teens With Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the effectiveness of interpersonal and social rhythm therapy in treating adolescents with a bipolar spectrum disorder
Detailed Description
Bipolar disorder is a brain disorder that causes dramatic changes in a person's mood and energy. Bipolar spectrum disorders, including bipolar I, II, and not-otherwise-specified (NOS) disorders, usually form in late adolescence or early adulthood and require treatment for the rest of a person's life. People with a bipolar spectrum disorder undergo periods of extreme happiness and extreme sadness, known as episodes of mania and depression. Psychotherapy has proven an effective adjunct treatment to medications for people with bipolar disorder. Interpersonal and social rhythm therapy (IPSRT) is a specific type of psychotherapy that focuses on improving problems in interpersonal relationships that are related to a person's symptoms. Researchers believe that IPSRT helps people have more regular patterns of sleep, eating, and other activities that act to set a person's biological clock. This study will specifically adapt IPSRT to the developmental needs of adolescents and will determine the effectiveness of this approach in treating adolescents with a bipolar spectrum disorder. Participants in this study will be randomly assigned to receive interpersonal and social rhythm therapy for adolescents (IPSRT-A) or treatment as usual (TAU). Participants assigned to IPSRT-A will take part in 18 sessions of IPSRT over a 20-week period. Beginning with the first session, participants will meet with a therapist weekly for 16 weeks and then every other week for 4 weeks. Each IPSRT session will last about 45 to 60 minutes, and parents will be asked to accompany the child to 2 to 4 of these sessions. During IPSRT sessions, the therapist will talk with participants about their relationships and how they relate to symptoms; work with participants to help improve understanding of how their social and sleep routines relate to symptoms; and teach participants about bipolar disorder. Participants assigned to TAU will be given educational information about bipolar disorder and its treatment. They will then be referred to a mental health provider for usual care treatment. All participants and parents will complete questionnaires about symptoms every 4 weeks during the study. Follow-up assessments will occur at the end of treatment and again at Months 3 and 6 post-treatment. These assessments will last between 60 and 90 minutes and will include completing an interview and questionnaires. Participants will also be asked for permission to obtain grade point average (GPA) and attendance records from their schools.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Adolescent, Psychopathology, Interpersonal Therapy, Interpersonal and Social Rhythm Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive treatment as usual
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive interpersonal and social rhythm therapy for adolescents
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal and Social Rhythm Therapy for Adolescents (IPSRT-A)
Intervention Description
IPSRT-A involves 20 weeks of individual therapy, incorporating informed psychological, behavioral, and practical strategies adapted to the developmental needs of adolescents.
Intervention Type
Behavioral
Intervention Name(s)
Treatment As Usual (TAU)
Intervention Description
TAU includes the offering of educational information about bipolar disorder and referral to a mental health provider.
Primary Outcome Measure Information:
Title
Brief Psychiatric Rating Scale for Children
Time Frame
Measured at pretreatment, every 4 weeks during treatment, post-treatment, and 3 and 6 month follow-ups
Secondary Outcome Measure Information:
Title
Mania Rating Scale (MRS), Beck Depression Inventory (BDI),Child Behavior Checklist (CBCL), Youth Self-Report Form (YSR), Social Adjustment Scale for Adolescents (SAS-SR-A), Conflict Behavior Questionnaire (CBQ)
Time Frame
Measured at pretreatment, post-treatment, 6 month follow-up, and various other times throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-IV diagnosis of bipolar spectrum disorder: type I, type II, or NOS Currently meets DSM-IV criteria for a depressed, manic, hypomanic, or mixed episode Youth assent/parental consent to outpatient psychotherapy for treatment of bipolar disorder Adequate access to transportation or close proximity in order to participate in therapy Exclusion Criteria: DSM-IV diagnosis of schizophrenia, schizophreniform, or schizoaffective disorders Developmentally delayed Actively psychotic, suicidal, homicidal, or engages in repeated parasuicidal behaviors History of chronic suicidality (e.g., more than three suicidal gestures in the year prior to study entry) Neurological or other medical disorder that could potentially cause or complicate presenting psychiatric symptoms Meets current DSM-IV criteria for drug or alcohol abuse or dependence Life circumstances that would prohibit ability to participate, including absence of shelter or impending jail/prison for more than 2 weeks during study Parent/legal guardian refusal to participate with the adolescent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefanie Hlastala, PhD
Organizational Affiliation
University of Washington, Children's Hospital and Regional Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

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Interpersonal and Social Rhythm Therapy for Adolescents With Bipolar Disorder

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