Interpersonal and Social Rhythm Therapy for Adolescents With Bipolar Disorder

NCT00576355 | Completed

• 3 other identifiers: K23MH0705705K23MH070570-03DDTR BK-TKAR
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bipolar Disorder

Keywords

Adolescent; Psychopathology; Interpersonal Therapy; Interpersonal and Social Rhythm Therapy

Outcome Measures

Primary Outcomes (1)

• Brief Psychiatric Rating Scale for Children

  Measured at pretreatment, every 4 weeks during treatment, post-treatment, and 3 and 6 month follow-ups

Secondary Outcomes (1)

• 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

Study Arms (2)

2

ACTIVE COMPARATOR

Participants will receive treatment as usual

Behavioral: Treatment As Usual (TAU)

1

EXPERIMENTAL

Participants will receive interpersonal and social rhythm therapy for adolescents

Behavioral: Interpersonal and Social Rhythm Therapy for Adolescents (IPSRT-A)

Interventions

Interpersonal and Social Rhythm Therapy for Adolescents (IPSRT-A) BEHAVIORAL

IPSRT-A involves 20 weeks of individual therapy, incorporating informed psychological, behavioral, and practical strategies adapted to the developmental needs of adolescents.

1

Treatment As Usual (TAU) BEHAVIORAL

TAU includes the offering of educational information about bipolar disorder and referral to a mental health provider.

2

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Stefanie Hlastala, PhD

  University of Washington, Children's Hospital and Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 19, 2007
• Study Start: December 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 20, 2012

Record last verified: 2012-06

Locations

US (1)