Early intervention for youth at high risk for bipolar disorder
NA · University of Pittsburgh · NCT04815239
This study is testing if a new therapy delivered online can help teenagers at high risk for bipolar disorder manage their mood and sleep better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | University of Pittsburgh (other) |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT04815239 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the efficacy of Interpersonal and Social Rhythm Therapy (IPSRT) delivered via telehealth for adolescents aged 12-18 who are at high risk for developing bipolar disorder due to having a parent with the condition. Participants will undergo a baseline assessment of psychiatric symptoms and sleep disturbances before being randomized to receive either IPSRT or a Healthy Lifestyle Behaviors Program. The study aims to assess the impact of these interventions on mania and affective lability over an 18-month period, while also exploring the underlying mechanisms related to sleep and interpersonal stress. The trial is designed to provide evidence-based preventive strategies for youth at risk of bipolar disorder.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12-18 with a parent diagnosed with bipolar disorder and a baseline risk calculator score greater than 0.05.
Not a fit: Patients with a lifetime diagnosis of bipolar disorder or current unstabilized psychiatric symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the onset of bipolar disorder in high-risk youth.
How similar studies have performed: Previous studies have shown promising results for similar interventions targeting high-risk populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 12-18 years * A parent with a diagnosis of BP I or II * Baseline Risk Calculator score\>0.05; * Able/willing to give informed consent/assent Exclusion Criteria: * A lifetime diagnosis of BP I or II * Current unstabilized psychiatric symptoms * Evidence of developmental disorder or central nervous system disorder
Where this trial is running
Pittsburgh, Pennsylvania
- Nicole Arnold — Pittsburgh, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Tina R Goldstien, PhD — University of Pittsburgh
- Study coordinator: Nicole Arnold, MA
- Email: arnoldne@upmc.edu
- Phone: 412-246-5796
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bipolar Disorder, psychosocial treatment, early intervention, prevention, adolescent