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Behavioural Intervention

Telehealth Cognitive Behavioral Therapy for High Risk of Psychosis

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

Study Summary

This trial will evaluate if telehealth can make it easier to access early psychosis treatment, potentially reducing illness severity and improving patient outcomes.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Global Functioning: Social (GFS) Scale

The Global Functioning: Role (GFR) Scale

Secondary outcome measures

Angry Behaviors Scale (ABS)

Davos Assessment of Cognitive Biases

Family Attitudes Scale (FAS)

+3 more

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

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Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

862 Previous Clinical Trials

525,554 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,637 Total Patients Enrolled

Yulia LandaPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

CBT Skills Group for CHR Youth (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05968560 — N/A

High Risk for Psychosis Research Study Groups: 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)

High Risk for Psychosis Clinical Trial 2023: CBT Skills Group for CHR Youth Highlights & Side Effects. Trial Name: NCT05968560 — N/A

CBT Skills Group for CHR Youth (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05968560 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must a patient meet to be eligible for this clinical research study?

"This medical trial is seeking up to 72 participants who possess a high-risk of developing psychosis and fall within the 14 - 25 age range."

Answered by AI

Are there any vacancies left for participants in this research project?

"As indicated by clinicaltrials.gov, this trial is seeking volunteers and was initially posted on July 21st 2023 with the most recent update also occuring on that same day."

Answered by AI

Does this research permit individuals of senior age to participate?

"This particular trial is open to adolescents between the ages of 14 and 25. In contrast, there are 118 studies for minors under 18 years old and 268 trials targeting individuals that exceed 65 years of age."

Answered by AI

How many participants are incorporated in this investigation?

"Indeed, clinicaltrials.gov corroborates that this medical trial is recruiting patients; the details were first posted on July 21st 2023 and adjusted more recently on the same day. 72 individuals need to be sourced from a single centre for eligibility in this research."

Answered by AI

What goal is this research endeavor attempting to accomplish?

"This trial, to be evaluated over a period of up to 28 weeks, primarily aims to measure Global Functioning: Social (GFS) Scale. Secondary endpoints encompass the Peters' Delusions Inventory (PDI), which assesses 21 common delusional thoughts and related distress, preoccupation and conviction; Davos Assessment of Cognitive Biases, measuring cognitive biases across 7 sub-scales; and Social Connectedness Scale Revised estimating one's degree of social connection with their environment."

Answered by AI

Recent research and studies

Early Intervention in PsychiatryJournal

Development of a Group and Family-based Cognitive Behavioural Therapy Program for Youth at Risk for Psychosis

Landa, Yulia, Kim T. Mueser, Katarzyna E. Wyka, Erica Shreck, Rachel Jespersen, Michael A. Jacobs, Kenneth W. Griffin, et al.. 2015. “Development of a Group and Family-based Cognitive Behavioural Therapy Program for Youth at Risk for Psychosis”. Early Intervention in Psychiatry. Wiley. doi:10.1111/eip.12204.

clinicaltrials.govStudy

Telehealth Cognitive Behavioral Therapy for Youth at Risk for Psychosis

Yulia Landa 2023. "Telehealth Cognitive Behavioral Therapy for Youth at Risk for Psychosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05968560.