RECRUITING

Telehealth Cognitive Behavioral Therapy for Youth at Risk for Psychosis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Telehealth Adaptation of Group and Family-Based Cognitive Behavioral Therapy for Youth at Risk for Psychosis

Quick Facts

Study Start:2023-07-21
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05968560

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 14-25
  2. * Ability to participate in assessments and treatment in English
  3. * Meets criteria for psychosis-risk on SIPS
  4. * Stable on medications; no changes within 1 month prior to enrollment
  5. * 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).
  1. * Intellectual disability (IQ\<70)
  2. * Medical condition known to cause psychosis
  3. * Moderate or severe substance use disorder and active use within the past 30 days.

Contacts and Locations

Study Contact

Yulia Landa, PsyD, MS
CONTACT
212-585-4658
yulia.landa@mssm.edu
Rachel Jespersen, LMSW
CONTACT
212-585-4641
rachel.jespersen@mssm.edu

Principal Investigator

Yulia Landa
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Yulia Landa, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-21
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-07-21
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Clinical High Risk for Psychosis (CHR)