Bipolar Disorder Clinical Trial
Official title:
Adjunctive Psychotherapy for Teens With Bipolar Disorder
This study will evaluate the effectiveness of interpersonal and social rhythm therapy in treating adolescents with a bipolar spectrum disorder
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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