Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting NA study of Clinical High Risk for Psychosis (CHR), sponsored by Icahn School of Medicine at Mount Sinai.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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 r
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2023-07-21 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What NCT05968560 shows while recruiting
NCT05968560 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Clinical High Risk for Psychosis (CHR)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05968560's enrollment target sits among peer trials
72 1089th of 2000 higher than 899 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02359253 · 72 participants · NA
Robot Aided Rehabilitation - Intervention
- NCT02962661 · 72 participants · Phase 1
Donor Bone Marrow Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients With Cardiomyopathy Caused by Anthracyclines
- NCT03113643 · 72 participants · Phase 1
SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- NCT03187535 · 72 participants · NA
Effect of TEAS on PONV After Spinal Surgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI