What side effects are associated with this type of intervention?

The most common side effects of telehealth-delivered Cognitive Behavioral Therapy (CBT) for individuals at high risk for psychosis include temporary increases in anxiety or distress as patients work through challenging thoughts and behaviors. Additionally, telehealth interventions may present challenges such as technical issues, reduced personal interaction, and potential difficulties in establishing a therapeutic alliance. Despite these side effects, the benefits of improved accessibility and engagement in treatment often outweigh these concerns.

What other types of research exist?

Promising novel alternatives to Telehealth-Delivered CBT for high-risk psychosis patients include: 1) Virtual Reality (VR)-based CBT, which uses immersive environments to practice social skills and reduce cognitive biases; 2) Mobile app-based interventions that provide real-time cognitive and behavioral support; 3) Digital platforms offering peer support and psychoeducation; 4) Augmented Reality (AR) for exposure therapy and cognitive restructuring; and 5) AI-driven personalized therapy programs that adapt to individual patient needs and progress.

← Back to Search

Behavioural Intervention

Telehealth Cognitive Behavioral Therapy for High Risk of Psychosis

Q: What prior FDA approvals exist?

The FDA has not specifically approved any medications or telehealth-delivered cognitive-behavioral therapies (CBT) for individuals at high risk for psychosis. However, traditional CBT, which focuses on cognitive restructuring and behavioral interventions to address cognitive biases and improve psychosocial functioning, is a well-established treatment for psychosis and related conditions. This form of therapy has been adapted for telehealth to increase accessibility and engagement, particularly for youth and young adults who may face barriers to in-person treatment.

N/A

Recruiting

Led By Yulia Landa

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 28

Awards & highlights

No Placebo-Only Group

Summary

This trial tests telehealth-based Cognitive Behavioral Therapy for young people at high risk of psychosis. It aims to make therapy more accessible and effective by offering group, family, and individual sessions online. The study will measure how well these methods work in improving mental health and preventing the onset of psychosis.

Who is the study for?

This trial is for young people aged 14-25 who are at high risk for psychosis, can participate in English, and have been stable on medications for at least a month. They need to identify a 'family member' willing to join the study. It's not open to those with intellectual disabilities, medical conditions causing psychosis, or recent moderate/severe substance use.

What is being tested?

The study tests telehealth Cognitive Behavioral Therapy (CBT) interventions: group CBT for youth and families, family-based CBT, and individual sessions. Participants will be randomly assigned to one of these methods to see how well they work over distance communication tools.

What are the potential side effects?

Since this trial involves therapy sessions rather than medication, traditional side effects aren't expected. However, participants may experience emotional discomfort discussing personal issues during therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Global Functioning: Social (GFS) Scale

The Global Functioning: Role (GFR) Scale

Secondary study objectives

Angry Behaviors Scale (ABS)

Davos Assessment of Cognitive Biases

Family Attitudes Scale (FAS)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Group and Family-Based Cognitive Behavioral Therapy (GF-CBT-TH)Experimental Treatment3 Interventions

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

Group II: Family-Based Cognitive Behavioral Therapy (F-CBT-TH)Experimental Treatment2 Interventions

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.

Group III: Individual Cognitive Behavioral Therapy (I-CBT-TH)Active Control1 Intervention

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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive Behavioral Therapy (CBT) for High Risk for Psychosis (CHR) patients works through cognitive restructuring and behavioral interventions to address cognitive biases and improve psychosocial functioning. This approach is crucial for CHR patients as it helps them identify and modify distorted thinking patterns and maladaptive behaviors, thereby enhancing cognitive flexibility and social skills. These improvements can lead to better overall functioning and may reduce the severity or progression of psychotic symptoms.

Compensatory Cognitive Training for Latino Youth at Clinical High Risk for Psychosis: Study Protocol for a Randomized Controlled Trial.