Interpersonal and Social Rhythm Therapy for Adolescents With Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Adjunctive Psychotherapy for Teens With Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576355
• Other study ID #: K23MH070570
• Secondary ID: K23MH0705705K23M
• Status: Completed
• Phase: N/A
• First received: December 17, 2007
• Last updated: June 19, 2012
• Start date: December 2007
• Est. completion date: August 2010

Study information

• Verified date: June 2012
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effectiveness of interpersonal and social rhythm therapy in treating adolescents with a bipolar spectrum disorder

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 19 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Behavioral:
• Interpersonal and Social Rhythm Therapy for Adolescents (IPSRT-A)
IPSRT-A involves 20 weeks of individual therapy, incorporating informed psychological, behavioral, and practical strategies adapted to the developmental needs of adolescents.
• Treatment As Usual (TAU)
TAU includes the offering of educational information about bipolar disorder and referral to a mental health provider.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Psychiatric Rating Scale for Children		Measured at pretreatment, every 4 weeks during treatment, post-treatment, and 3 and 6 month follow-ups	No
Secondary	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)		Measured at pretreatment, post-treatment, 6 month follow-up, and various other times throughout study	No