Early Intervention for Youth at High Risk for Bipolar Disorder

Bipolar Disorder Clinical Trial

— KEY  

Official title:

Early Intervention for Youth at High Risk for Bipolar Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04815239
• Other study ID #: STUDY21010149
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: April 30, 2026

Study information

• Verified date: September 2023
• Source: University of Pittsburgh
• Contact: Nicole Arnold, MA
• Phone: 412-246-5796
• Email: arnoldne[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators will conduct a confirmatory efficacy trial of Interpersonal and Social Rhythm Therapy (IPSRT) delivered via telehealth for offspring of bipolar parents (OBP; age 12-18, n=120) at elevated risk for BP onset via risk calculator score. All participants receive a baseline clinical assessment of psychiatric symptoms and sleep disturbance (via objective and subjective methods), followed by a feedback session. Youth are then randomized to receive 8 sessions of IPSRT or a manualized Healthy Lifestyle Behaviors Program (HL) delivered via secure videoconference. As clinically indicated, youth are offered Community Treatment Referral (CTR) for any psychiatric symptoms/disorders identified at intake. Primary outcome domains over 18 months include mania and affective lability. Investigators will also further investigate the hypothesized mechanism underlying IPSRT (i.e., sleep/circadian disruption) across levels of analysis, and the contribution of interpersonal stress to sleep/circadian disruptions. Application of Implementation Science methods throughout maximizes ultimate scalability and feasibility if efficacious. Investigators will also examine whether passive cellphone sensing may serve as a portable, cost-effective measure of mechanisms and outcomes to enhance ultimate dissemination.

Description:

The most potent risk factor for the development of bipolar disorder (BP) is a first-degree family member with the illness; individuals with family history typically experience early BP onset and severe course. Up to 25% of offspring of parents with BP (OBP) develop BP by young adulthood. Using longitudinal data from the Pittsburgh Bipolar Offspring Study (BIOS MH60952), investigators developed a clinical tool ("risk calculator") that reliably predicts an individual OBP's 5-year risk for BP using a subset of demographic and clinical variables. This innovation offers the ideal opportunity to identify OBP at greatest risk and deliver indicated preventive interventions. Yet, to date, there is no evidence-based intervention for OBP who have not already developed mood disorder. Per the experimental therapeutics framework, promising approaches should be informed by, and target, factors that cause and sustain illness. Evidence suggests the pathway to develop BP among biologically vulnerable youth involves sleep and circadian disturbances. Investigators adapted Interpersonal and Social Rhythm Therapy (IPSRT), an evidence-based treatment for BP adults that helps stabilize sleep/ circadian patterns, for adolescent OBP. In an open pilot and subsequent R34 randomized trial (MH091177), Investigators established a preliminary efficacy signal for IPSRT with OBP. Investigators' data further indicate IPSRT, but not Community Treatment Referral (CTR), engages and alters the hypothesized mechanism of action--sleep/ circadian disturbance, although practical barriers impacted treatment attendance. This proposal represents a vital next step in this program of research: a confirmatory efficacy trial of IPSRT delivered via telehealth for OBP (age 12-18, n=120) at elevated risk for BP onset via risk calculator score. All participants receive a baseline clinical assessment of psychiatric symptoms and sleep disturbance (via objective and subjective methods), followed by a feedback session. Youth are then randomized to receive 8 sessions of IPSRT or a manualized Healthy Lifestyle Behaviors Program (HL) delivered via secure videoconference to enhance attendance and reach. As clinically indicated, youth are offered CTR for any psychiatric symptoms/disorders identified at intake. Primary outcome domains over 18 months include mania and affective lability--2 potent near-term predictors of BP in OBP that are themselves associated with morbidity and impairment. Investigators will also further investigate the hypothesized mechanism underlying IPSRT-sleep/circadian disruption--across levels of analysis using reliable, cost-effective methods (actigraphy and daily diary ratings), and the contribution of interpersonal stress to sleep/circadian disruptions. Application of Implementation Science methods throughout maximizes ultimate scalability and feasibility if efficacious. Investigators will also examine whether passive cellphone sensing may serve as a portable, cost-effective measure of mechanisms and outcomes to enhance ultimate dissemination. Research in this area has the potential to prevent, delay, or ameliorate the progression of this chronic and devastating illness in those at highest risk.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Behavioral:
• Interpersonal and Social Rhythm Therapy (IPSRT)
Interpersonal and Social Rhythm Therapy (IPSRT) is an evidence-based treatment for BP adults that prevents or delays mood episodes by stabilizing sleep and daily routines.
• The Healthy Lifestyle Behavior Intervention (HL)
HL includes structured psychoeducational modules that aim to teach patients about health risks and help them achieve a balanced lifestyle to optimize physical and mental health.

Locations

Country	Name	City	State
United States	Nicole Arnold	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory: Association between actigraphy and passive sensing-derived measures of sleep-wake	Association between actigraphy and passive sensing-derived measures of sleep-wake	18 months
Primary	Risk for Subthreshold or Threshold Manic Episodes	Adolescent Longitudinal Interval Follow-Up Evaluation (ALIFE) Psychiatric Status Ratings (PSR; Range 1-6)	18 months
Primary	Rate of Subthreshold or Threshold Manic Symptoms	Kiddie Schedule for Affective Disorders and Schizophrenia-Mania Rating Scale (KMRS; Range 0-64)	18 months
Primary	Severity of Affective lability	Children's Affective Lability Scale (CALS; Range 0-80)	18 months
Secondary	Total sleep time (Objective)	Actigraphy-derived mean total sleep time	18 months
Secondary	Total sleep time (subjective)	Daily diary-derived mean total sleep time	18 months
Secondary	Sleep variability (objective)	Actigraphy-derived sleep variability	18 months
Secondary	Sleep variability (subjective)	Daily diary-derived sleep variability	18 months