RecruitingNot ApplicableNCT05968560

Telehealth Cognitive Behavioral Therapy for Youth at Risk for Psychosis

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


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

72 participants

Start Date

Jul 21, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 14 YearsMax Age: 25 Years

Inclusion Criteria5

  • Age 14-25
  • Ability to participate in assessments and treatment in English
  • Meets criteria for psychosis-risk on SIPS
  • Stable on medications; no changes within 1 month prior to enrollment
  • 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).

Exclusion Criteria3

  • Intellectual disability (IQ\<70)
  • Medical condition known to cause psychosis
  • Moderate or severe substance use disorder and active use within the past 30 days.

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Interventions

BEHAVIORALCBT Skills Group for CHR Youth

CBT skills group is designed to boost peer support, reduce isolation, normalize psychotic-like experiences to lessen distress, reduce cognitive biases, facilitate positive beliefs, and enhance reasoning and decision-making. CBT skills group uses "CBT to Prevent Paranoia" manual to teach individuals to make adaptive appraisals of their experiences (e.g. voices and other cognitive intrusions) to prevent the perception of such events as threatening.

BEHAVIORALIndividual CBT sessions

CBT skills learned in group are personalized in individual sessions focused on: a) facilitating learning of CBT skills; b) tailoring CBT skills to personal goals; c) facilitating successful interaction with peers in the group; and d) providing academic and vocational support. Youth may opt to invite family members to join individual sessions as needed.

BEHAVIORALCBT Skills Group for Families

Family members are taught the same CBT skills that are taught to CHR youth to facilitate use of CBT skills at home. Family members also learn how to prompt CHR youth to use CBT skills through effective communication, such as empathic listening and encouraging alternative explanations. CBT skills group for family members uses a combination of didactic learning (skills are described in "CBT Skills for Families" manual and demonstrated via video examples) and practice (skills are role-played). Youth attend one group session and one individual session per week, and family members attend one group session per week.


Locations(1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

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NCT05968560


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