About this trial
This study aims to evaluate the feasibility and effectiveness of telehealth interventions for individuals at clinical high risk for psychosis (CHR). Psychosis typically emerges during late adolescence or early adulthood, significantly impacting long-term functioning. While CHR programs have the potential to reduce illness severity, individuals often face barriers such as stigma and limited access to services. Telehealth interventions could address these barriers and improve treatment accessibility and engagement. The study will focus on Group and Family-Based Cognitive Behavioral Therapy, Family-Based CBT, and individual CBT, adapted for telehealth delivery (GF-CBT-TH, F-CBT-TH, and I-CBT-TH). Participants aged 14-25 who meet CHR criteria will be randomly assigned to one of these interventions. Feasibility will be measured by recruitment rate, attendance, and retention. The study will assess the impact of the interventions on cognitive biases, social connectedness, family emotional climate, and proficiency in CBT skills. The three intervention groups will be compared in terms of psychosocial functioning, symptom severity, rates of remission from CHR, and rates of transition to psychosis. Additionally, factors like patient treatment preference, family emotional climate, and sociodemographic factors will be explored as potential moderators of treatment outcomes. Qualitative interviews will be conducted with participants and clinicians to inform dissemination efforts.
Eligibility criteria
Qualifiers
Age 14-25
Ability to participate in assessments and treatment in English
Meets criteria for psychosis-risk on SIPS
Stable on medications; no changes within 1 month prior to enrollment
Disqualifiers
Intellectual disability (IQ<70)
Medical condition known to cause psychosis
Moderate or severe substance use disorder and active use within the past 30 days.
Trial design
Treatments tested in this trial
- CBT Skills Group for CHR Youth
- Individual CBT sessions
- CBT Skills Group for Families
Treatment groups
Sponsors and collaborators
Icahn School of Medicine at Mount Sinai
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator