Recruiting

Cognitive Behavioral Therapy

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05968560

Conditions

Clinical High Risk for Psychosis (CHR)

Eligibility Criteria

Sex: All

Age: 14 - 25

Healthy Volunteers: Not accepted

Interventions

CBT Skills Group for CHR Youth

Individual CBT sessions

CBT Skills Group for Families

Study Details

Brief summary:

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.

Conditions

Clinical High Risk for Psychosis (CHR)

Study ID

NCT05968560

Start date

Jul 21, 2023

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 25

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

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

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.

active comparator: Individual Cognitive Behavioral Therapy (I-CBT-TH)

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.

Interventions

CBT Skills Group for CHR Youth

CBT skills group is designed to boost peer support, reduce isolation, normalize psychotic-like experiences to lessen distress, reduce cognitive biases, facilitate positive beliefs, and enhance reasoning and decision-making. CBT skills group uses "CBT to Prevent Paranoia" manual to teach individuals to make adaptive appraisals of their experiences (e.g. voices and other cognitive intrusions) to prevent the perception of such events as threatening.

Individual CBT sessions

CBT skills learned in group are personalized in individual sessions focused on: a) facilitating learning of CBT skills; b) tailoring CBT skills to personal goals; c) facilitating successful interaction with peers in the group; and d) providing academic and vocational support. Youth may opt to invite family members to join individual sessions as needed.

CBT Skills Group for Families

Family members are taught the same CBT skills that are taught to CHR youth to facilitate use of CBT skills at home. Family members also learn how to prompt CHR youth to use CBT skills through effective communication, such as empathic listening and encouraging alternative explanations. CBT skills group for family members uses a combination of didactic learning (skills are described in "CBT Skills for Families" manual and demonstrated via video examples) and practice (skills are role-played). Youth attend one group session and one individual session per week, and family members attend one group session per week.

Primary outcome measure

  • The Global Functioning: Role (GFR) Scale [ Time Frame: Up to week 28 ]
  • Global Functioning: Social (GFS) Scale [ Time Frame: Up to week 28 ]

Central Contacts and Locations

Central contacts

Yulia Landa, PsyD, MS

212-585-4658yulia.landa@mssm.edu

Rachel Jespersen, LMSW

212-585-4641rachel.jespersen@mssm.edu

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Yulia Landa, PsyD,MS

212-585-4658yulia.landa@mssm.edu

Rachel Jespersen, LMSW

212-585-4641rachel.jespersen@mssm.edu

Principal Investigator:

Yulia Landa

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-01-20.