Telehealth Cognitive Behavioral Therapy for Youth at Risk for Psychosis

Recruiting now · Not applicable

Conditions studied: Clinical High Risk for Psychosis (CHR)

In brief

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.

Key facts

Study ID

NCT05968560

Run by

Icahn School of Medicine at Mount Sinai

People needed

72

Starts

2023-07-21

Expected to finish

2026-12-31

Last updated by the study team

2026-01-20

Who can join

Age: 14 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Identification of one "family member" with >4 hours/week contact who is willing to participate ("Family member" can be any blood relative, spouse, significant other, or close friend whom the subject identifies as a consistent and important person in their life).

You may not qualify if…

• Intellectual disability (IQ<70)
• Medical condition known to cause psychosis
• Moderate or severe substance use disorder and active use within the past 30 days.

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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