Interpersonal and Social Rhythm Therapy for Adolescents With Bipolar Disorder
|ClinicalTrials.gov Identifier: NCT00576355|
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : June 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Behavioral: Interpersonal and Social Rhythm Therapy for Adolescents (IPSRT-A) Behavioral: Treatment As Usual (TAU)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjunctive Psychotherapy for Teens With Bipolar Disorder|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
Active Comparator: 2
Participants will receive treatment as usual
Behavioral: Treatment As Usual (TAU)
TAU includes the offering of educational information about bipolar disorder and referral to a mental health provider.
Participants will receive interpersonal and social rhythm therapy for adolescents
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.
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576355
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Stefanie Hlastala, PhD||University of Washington, Children's Hospital and Regional Medical Center|