Telehealth Cognitive Behavioral Therapy for Youth at Risk for Psychosis

NCT05968560 | Recruiting DMC

• 2 other identifiers: GCO 21-0328R34MH128502
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (2)

• The Global Functioning: Role (GFR) Scale

  The Global Functioning: Role (GFR) scale, clinician administered scales, derived from the GAF format. The GFR scale anchor points refer to performance in school, work, or as a homemaker, depending on their primary role. The GFS scale assesses quantity and quality of peer relationships, level of peer conflict, age appropriate intimate relationships, and involvement with family members. Ratings on a 10-point scale (1= Extreme Role Dysfunction to 10 = Superior Role Functioning) with higher scores representing better role functioning.

  Up to week 28

• Global Functioning: Social (GFS) Scale

  The Global Functioning: Social (GFS) scales, clinician administered scales, derived from the GAF format. The GFS scale assesses quantity and quality of peer relationships, level of peer conflict, age appropriate intimate relationships, and involvement with family members. The GFS scale scores range from 1 to 10 with higher scores representing better social functioning.

  Up to week 28

Secondary Outcomes (6)

• The Structured Interview for Psychosis Risk Syndromes (SIPS)

  Up to week 28

• Peters' Delusions Inventory (PDI)

  Up to week 28

• Davos Assessment of Cognitive Biases

  Up to week 28

• Social Connectedness Scale Revised

  Up to week 28

• Family Attitudes Scale (FAS)

  Up to week 28

Study Arms (3)

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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.

Behavioral: Individual CBT sessions; Behavioral: CBT Skills Group for Families

Individual Cognitive Behavioral Therapy (I-CBT-TH)

ACTIVE COMPARATOR

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.

Behavioral: Individual CBT sessions

Interventions

Individual CBT sessions BEHAVIORAL

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.

Family-Based Cognitive Behavioral Therapy (F-CBT-TH); Group and Family-Based Cognitive Behavioral Therapy (GF-CBT-TH); Individual Cognitive Behavioral Therapy (I-CBT-TH)

CBT Skills Group for Families BEHAVIORAL

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.

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

CBT Skills Group for CHR Youth BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Related Publications (1)

• Landa Y, Mueser KT, Wyka KE, Shreck E, Jespersen R, Jacobs MA, Griffin KW, van der Gaag M, Reyna VF, Beck AT, Silbersweig DA, Walkup JT. Development of a group and family-based cognitive behavioural therapy program for youth at risk for psychosis. Early Interv Psychiatry. 2016 Dec;10(6):511-521. doi: 10.1111/eip.12204. Epub 2015 Jan 13.

  PMID: 25585830 BACKGROUND

Study Officials

• Yulia Landa

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yulia Landa, PsyD, MS

CONTACT

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

Rachel Jespersen, LMSW

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 1, 2023
• Study Start: July 21, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. Any purpose. Specify Other Mechanism Data will be shared via secured file sharing platform

Locations

US (1)