Interpersonal and Social Rhythm Therapy for Adolescents With Bipolar Disorder - Full Text View

Sponsored by:	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)

MedlinePlus related topics: Bipolar Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Adjunctive Psychotherapy for Teens With Bipolar Disorder

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

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) [ Time Frame: Measured at pretreatment, post-treatment, 6 month follow-up, and various other times throughout study ] [ Designated as safety issue: No ]

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.

Detailed Description:

Exposure to traumatic events has reached unprecedented proportions in American society, and the rates of PTSD have risen significantly, particularly among populations with repetitive exposure to critical incidents. The continued threat of attacks against Americans warrants development of preventive interventions to reduce the occurrence of PTSD and its precursor, ASD. This study will determine the feasibility of a preventive treatment in urban firefighters who have experienced a traumatic event.

In part one of the study, firefighters were administered a baseline assessment that included an interview and self-report questionnaires to measure depression, anxiety, coping skills, social support, physical health, and work functioning. In part two of the study firefighter focus groups were conducted to determine the feasibility of a one session cognitive behavioral treatment session that was developed to target cognitive, behavioral and physiological responses to stressors commonly associated with firefighting. Data analysis is ongoing.

Eligibility

Ages Eligible for Study:	12 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576355

Contacts

Contact: Stefanie Hlastala, PhD

866-987-2000 ext 3415

shlastal@u.washington.edu

Locations

United States, Washington
Children's Hospital and Regional Medical Center	Recruiting
Seattle, Washington, United States, 98105

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

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:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00576355
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Adolescent
Psychopathology
Interpersonal Therapy
Interpersonal and Social Rhythm Therapy

Study placed in the following topic categories:

Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Mood Disorders
Psychotic Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 30, 2009