|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00576355 |
Purpose
This study will evaluate the effectiveness of interpersonal and social rhythm therapy in treating adolescents with a bipolar spectrum disorder
| Condition | Intervention |
|---|---|
|
Bipolar Disorder |
Behavioral: Interpersonal and Social Rhythm Therapy for Adolescents (IPSRT-A) Behavioral: Treatment As Usual (TAU) |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Adjunctive Psychotherapy for Teens With Bipolar Disorder |
| Estimated Enrollment: | 36 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
2: Active Comparator
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.
|
|
1: Experimental
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.
|
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.
Eligibility| Ages Eligible for Study: | 12 Years to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Stefanie Hlastala, PhD | 866-987-2000 ext 3415 | shlastal@u.washington.edu |
| United States, Washington | |
| Seattle Children's Hospital | Recruiting |
| Seattle, Washington, United States, 98105 | |
| Principal Investigator: | Stefanie Hlastala, PhD | University of Washington, Children's Hospital and Regional Medical Center |
More Information
| Responsible Party: | University of Washington, Children's Hospital and Regional Medical Center ( Stephanie Hlastala, PhD ) |
| Study ID Numbers: | K23 MH070570, 5K23MH070570-03, DDTR BK-TKAR |
| Study First Received: | December 17, 2007 |
| Last Updated: | March 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00576355 History of Changes |
| Health Authority: | United States: Federal Government |
|
Adolescent Psychopathology Interpersonal Therapy Interpersonal and Social Rhythm Therapy |
|
Affective Disorders, Psychotic Pathologic Processes Disease |
Mental Disorders Bipolar Disorder Mood Disorders |