Telehealth Cognitive Behavioral Therapy for Youth at Risk for Psychosis

Official title

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

Overview

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.

Detailed description

Psychosis typically emerges in late adolescence or early adulthood, which is a vital stage in social and cognitive development, and can therefore have a profoundly adverse impact on an individual's long-term functioning. The onset of psychosis is preceded by a clinical high risk (CHR) phase characterized by attenuated psychotic symptoms and functional decline. CHR programs have enormous potential to reduce the long-term severity of the illness, and the suffering and cost associated with it. Youth at CHR also typically have environmental and individual-level barriers to accessing and engaging in services, including stigma, a dearth of trained providers, clinic location and transportation issues, suspiciousness, and a tendency to socially isolate. Reducing some of these barriers via telehealth interventions may improve treatment accessibility and engagement, thereby improving clinical outcomes. There is a substantial need to evaluate different CHR interventions to determine which are most effective. There is also a significant need to systematically investigate remote delivery methods as a way of increasing access to critical services for CHR. The research team have established Group and Family-Based Cognitive Behavioral Therapy (GF-CBT) program in order to facilitate psychosocial recovery, decrease symptoms, and prevent or delay transition to psychosis in youth at CHR. GF-CBT is grounded in sociocultural ecological systems theory, psychosocial resilience models, and research on information processing in delusions. GF-CBT has been implemented as part of SAMHSA funded CHR services in New York, Missouri, and Delaware. The research team have also established Family-Based CBT (F-CBT), in which youth and families learn CBT skills as a family unit, rather than in groups. The research team have adapted GF-CBT, F-CBT and individual CBT for telehealth delivery (GF-CBT-TH, F-CBT-TH and I-CBT-TH). This study will investigate the feasibility of implementing these telehealth interventions in the context of routine CHR services, evaluate the impact of the interventions on engaging target mechanisms hypothesized to underlie their effects, and conduct a preliminary evaluation of their comparative efficacy. Subjects between the ages of 14 and 25 who meet CHR criteria on the SIPS (n=72) and their families will be randomly assigned to receive GF-CBT-TH, F-CBT-TH or I-CBT-TH for a period of 15 weeks. Data will be collected at baseline, post-treatment, and 3-month follow-up. Feasibility will be measured by recruitment rate, attendance, and retention. The following intervention targets will be assessed: cognitive biases, social connectedness, family emotional climate, and family members' proficiency in CBT skills. The three groups will be compared across the following domains: psychosocial functioning, symptom severity, rates of remission from CHR, and rates of transition to psychosis. The research team will also explore whether patient treatment preference, family emotional climate and sociodemographic factors differentially moderate treatment outcomes. Qualitative interviews will be conducted with patients, families, and clinicians to inform dissemination and make adaptations to the implementation manuals.

Interventions

• Behavioral CBT 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.
• Behavioral Individual 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.
• Behavioral CBT 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). Yout

Primary outcome measures

• The Global Functioning: Role (GFR) Scale [Time frame: Up to week 28]
• Global Functioning: Social (GFS) Scale [Time frame: Up to week 28]

Secondary outcome measures (6)

• The Structured Interview for Psychosis Risk Syndromes (SIPS) [Time frame: Up to week 28]
• Peters' Delusions Inventory (PDI) [Time frame: Up to week 28]
• Davos Assessment of Cognitive Biases [Time frame: Up to week 28]
• Social Connectedness Scale Revised [Time frame: Up to week 28]
• Family Attitudes Scale (FAS) [Time frame: Up to week 28]
• Angry Behaviors Scale (ABS) [Time frame: Up to week 28]

Eligibility criteria

Inclusion criteria

• 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 criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Icahn School of Medicine at Mount Sinai — New York

Publications

• Landa Y, Mueser KT, Wyka KE, Shreck E, Jespersen R, Jacobs MA, Griffin KW, van der Gaag M, Reyna VF, Beck AT, Silbersweig DA, Walkup JT. Development of a group and family-based cognitive behavioural therapy program for youth at risk for psychosis. Early Interv Psychiatry. 2016 Dec;10(6):511-521. doi: 10.1111/eip.12204. Epub 2015 Jan 13. PMID 25585830

Identifiers

NCT: NCT05968560 · GCO 21-0328 · R34MH128502

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗