Telehealth Cognitive Behavioral Therapy for Youth at Risk for Psychosis

Mount Sinai Health System

Status: Enrolling

Conditions: Clinical High Risk for Psychosis (CHR)

Treatments: Behavioral: Individual CBT sessions; Behavioral: CBT Skills Group for CHR Youth; Behavioral: CBT Skills Group for Families

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05968560

GCO 21-0328

R34MH128502 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Psychosis typically emerges in late adolescence or early adulthood, which is a vital stage in social and cognitive development, and can therefore have a profoundly adverse impact on an individual's long-term functioning. The onset of psychosis is preceded by a clinical high risk (CHR) phase characterized by attenuated psychotic symptoms and functional decline. CHR programs have enormous potential to reduce the long-term severity of the illness, and the suffering and cost associated with it. Youth at CHR also typically have environmental and individual-level barriers to accessing and engaging in services, including stigma, a dearth of trained providers, clinic location and transportation issues, suspiciousness, and a tendency to socially isolate. Reducing some of these barriers via telehealth interventions may improve treatment accessibility and engagement, thereby improving clinical outcomes. There is a substantial need to evaluate different CHR interventions to determine which are most effective. There is also a significant need to systematically investigate remote delivery methods as a way of increasing access to critical services for CHR. The research team have established Group and Family-Based Cognitive Behavioral Therapy (GF-CBT) program in order to facilitate psychosocial recovery, decrease symptoms, and prevent or delay transition to psychosis in youth at CHR. GF-CBT is grounded in sociocultural ecological systems theory, psychosocial resilience models, and research on information processing in delusions. GF-CBT has been implemented as part of SAMHSA funded CHR services in New York, Missouri, and Delaware. The research team have also established Family-Based CBT (F-CBT), in which youth and families learn CBT skills as a family unit, rather than in groups. The research team have adapted GF-CBT, F-CBT and individual CBT for telehealth delivery (GF-CBT-TH, F-CBT-TH and I-CBT-TH). This study will investigate the feasibility of implementing these telehealth interventions in the context of routine CHR services, evaluate the impact of the interventions on engaging target mechanisms hypothesized to underlie their effects, and conduct a preliminary evaluation of their comparative efficacy. Subjects between the ages of 14 and 25 who meet CHR criteria on the SIPS (n=72) and their families will be randomly assigned to receive GF-CBT-TH, F-CBT-TH or I-CBT-TH for a period of 15 weeks. Data will be collected at baseline, post-treatment, and 3-month follow-up. Feasibility will be measured by recruitment rate, attendance, and retention. The following intervention targets will be assessed: cognitive biases, social connectedness, family emotional climate, and family members' proficiency in CBT skills. The three groups will be compared across the following domains: psychosocial functioning, symptom severity, rates of remission from CHR, and rates of transition to psychosis. The research team will also explore whether patient treatment preference, family emotional climate and sociodemographic factors differentially moderate treatment outcomes. Qualitative interviews will be conducted with patients, families, and clinicians to inform dissemination and make adaptations to the implementation manuals.

Enrollment: 72 estimated patients

Sex: All

Ages: 14 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 3 patient groups

Group and Family-Based Cognitive Behavioral Therapy (GF-CBT-TH)

Experimental group

Description:

GF-CBT via telehealth is an intervention consisting of three parts: 15 group sessions for young people, 15 individual sessions for young people, and 15 group sessions for families. The group sessions for young people and families focus on teaching CBT skills. The goal is to enhance reasoning, decision-making, and positive beliefs while reducing cognitive biases, distress, and isolation. The individual sessions personalize the CBT skills learned in the group, focusing on tailoring skills to personal goals. Family members also participate in group sessions to learn the same CBT skills and how to prompt and support their young family members in using these skills. All sessions are conducted via Telehealth

Treatment:

Behavioral: CBT Skills Group for Families

Behavioral: CBT Skills Group for CHR Youth

Behavioral: Individual CBT sessions

Family-Based Cognitive Behavioral Therapy (F-CBT-TH)

Experimental group

Description:

F-CBT via telehealth consists of two parts: 15 family sessions and 15 individual sessions for young people. The family sessions focus on teaching CBT skills to a family units. The individual sessions with youth personalize the CBT skills learned in the family sessions, focusing on tailoring skills to personal goals. All sessions are conducted via Telehealth.

Treatment:

Behavioral: CBT Skills Group for Families

Behavioral: Individual CBT sessions

Individual Cognitive Behavioral Therapy (I-CBT-TH)

Active Comparator group

Description:

I-CBT-TH via telehealth consists of two components: 15 CBT Skill Learning sessions and 15 follow-up session that personalizes the learned skills. All sessions are conducted via Telehealth.

Treatment:

Behavioral: Individual CBT sessions