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NCT05968560 · ClinicalTrials.gov registry record · NA

Telehealth Cognitive Behavioral Therapy for Youth at Risk for Psychosis

A NA study of Clinical High Risk for Psychosis (CHR), sponsored by Icahn School of Medicine at Mount Sinai.

Recruiting
Registry status
NA
Development phase
72
Enrollment target
1
Study location

NCT05968560 is a NA study of Clinical High Risk for Psychosis (CHR) that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 72 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT05968560, a NA study of Clinical High Risk for Psychosis (CHR), is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.

RECRUITING
Registry status
NA
Development phase
72 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • BEHAVIORAL CBT Skills Group for CHR Youth
  • BEHAVIORAL Individual CBT sessions
  • BEHAVIORAL CBT Skills Group for Families

Study Locations (1)

New York

  • Icahn School of Medicine at Mount Sinai - New York

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2023-07-21
Est. Completion 2026-12-31
Phase NA

What the Registry Record Tells You About NCT05968560

The ClinicalTrials.gov registry entry for NCT05968560 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Clinical High Risk for Psychosis (CHR) appearing as the primary indexed condition, and to 3 interventions - of which CBT Skills Group for CHR Youth is the first listed.

NCT05968560 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT05968560 about?

NCT05968560 is a clinical study titled "Telehealth Cognitive Behavioral Therapy for Youth at Risk for Psychosis". 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 pote...

What is the current status of trial NCT05968560?

This trial is currently recruiting. It is a NA study. The enrollment target is 72 participants. The study started on 2023-07-21. Estimated completion is 2026-12-31.

What conditions does trial NCT05968560 study?

This clinical trial studies the following conditions: Clinical High Risk for Psychosis (CHR).

What interventions are being tested in trial NCT05968560?

The interventions under investigation include: CBT Skills Group for CHR Youth (BEHAVIORAL), Individual CBT sessions (BEHAVIORAL), CBT Skills Group for Families (BEHAVIORAL).

Who is sponsoring clinical trial NCT05968560?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05968560 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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