Depression and Manic Depression Prevention Program
Pittsburgh, Pennsylvania, 15213, United States
NCT Number: NCT01520129
The investigators propose to conduct a 20 week open pilot study of Interpersonal and Social Rhythm Therapy (IPSRT) to treat individuals (n=18) with subthreshold bipolar (BP) who are currently depressed. The investigators will conduct a preliminary evaluation of sleep-wake and social rhythm patterns in study participants using questionnaires and actigraphy. Primary aims of this study are to evaluate feasibility of this treatment and assessment approach. Exploratory aims are to examine 1) sleep-wake and social rhythm patterns in subthreshold BP, 2) impact of IPSRT on symptoms and functioning over time and 3) relationship between sleep-wake and social rhythm patterns and treatment outcomes.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15213, United States
Subthreshold bipolar disorder (BP) is a common, understudied, illness associated with high levels of impairment. "Subthreshold" BP refers to individuals who have episodes of both depression and hypomania, but the episodes of hypomania do not last long enough or are characterized by too few symptoms to meet conventional criteria for "threshold" hypomania. Compared to individuals with episodes of depression only (major depressive disorder or MDD), individuals with subthreshold BP have higher rates of suicide, earlier onset of illness, more episodes of depression, and more co-occurring psychiatric disorders. Despite the severity of the disorder, virtually nothing is known about how to treat this illness.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IPSRT Subjects will receive weekly 45 minute sessions of IPSRT for 20 weeks. IPSRT sessions focus on reducing symptoms by teaching patients to: a) increase regularity of social rhythms and regulate sleep-wake cycles; b) resolve interpersonal problems that contribute to mood symptoms (role dispute, role transition, grief, or interpersonal deficits); and c) recognize and accept the symptoms of subthreshold BP disorder (psychoeducation). Although we train therapists in techniques that are specific to each component, in practice, these strategies are administered flexibly and fluidly, without distinct boundaries between modalities. During the course of a session, therapists move seamlessly among the techniques, according to patients' needs.
Other names: IPSRT
Time frame: 20 weeks
The primary endpoint is depression severity at week 20, which will be measured via the Hamilton Rating Scale for Depression 25-item score (HRSD-25) and the Young Mania Rating Scale (YMRS).
University of Pittsburgh
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00761761
Bipolar Disorder, Bipolar Disorder NOS
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT06740890
Behavior, Bipolar Disorder
New York, United States
View Trial DetailsNCT06920940
Adolescents, Bipolar Disorder
Los Angeles, California, United States
View Trial DetailsNCT06462586
Bipolar Disorder, Bipolar Disorder, Manic
Rogers, Arkansas, United States
View Trial Details