Telehealth Cognitive Behavioral Therapy for High Risk of Psychosis

Overseen By Rachel Jespersen, LMSW

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Intellectual disability, Medical condition, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 15 weeks

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether therapy delivered through telehealth can assist individuals at high risk of developing psychosis, a mental health condition affecting thoughts and perceptions. It adapts Cognitive Behavioral Therapy (CBT) for online delivery, using various approaches such as group sessions, family involvement, or individual sessions. The trial aims to overcome barriers like stigma and limited access to in-person services, assessing how well these telehealth methods enhance mental health and social connections. Ideal candidates are those aged 14-25 at high risk for psychosis who can communicate in English, along with a supportive family member or friend who can participate. Participants will be randomly assigned to one of the therapy types to determine which is most effective. As an unphased trial, this study provides a unique opportunity to contribute to innovative mental health solutions and improve future care.

Will I have to stop taking my current medications?

The trial requires that participants be stable on their medications, meaning no changes to their medication regimen for at least one month before joining the study. So, you won't have to stop taking your current medications, but you should not change them right before or during the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive Behavioral Therapy (CBT) is generally safe and well-tolerated. Studies have found that CBT can reduce the risk of serious mental health issues, like psychosis, in young people. When families learn CBT skills together, it can improve symptoms and social interactions in at-risk youth. Group and Family-Based CBT has also shown positive results, with research suggesting it might delay or prevent serious mental health issues in those at risk.

Past studies have reported no major negative effects from these therapies, indicating they are generally safe for participants. Using CBT through telehealth is a newer method, but it adheres to the same safe principles as in-person sessions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these telehealth cognitive behavioral therapy (CBT) approaches for individuals at high risk of psychosis because they could offer more accessible and flexible treatment options compared to traditional in-person therapy. The Family-Based CBT (F-CBT-TH) and Group and Family-Based CBT (GF-CBT-TH) treatments are distinctive because they incorporate family members into the therapy process, providing support and teaching skills to both the youth and their families, which can enhance the therapeutic effect and support system. Additionally, the entirely telehealth-based delivery method allows for broader reach and convenience, making it possible for young people and their families to participate from home, which can be particularly beneficial for those who have mobility issues or live in remote areas. This approach not only aims to teach CBT skills but also to personalize and integrate them into daily life, which could lead to more sustainable mental health improvements.

What evidence suggests that this trial's telehealth CBT interventions could be effective for individuals at high risk of psychosis?

This trial will compare different telehealth-based Cognitive Behavioral Therapy (CBT) approaches for individuals at high risk of psychosis. Research has shown that CBT can lower the risk of developing psychosis, especially in the short term. Participants may receive Family-Based Cognitive Behavioral Therapy (F-CBT-TH), which studies indicate can reduce symptoms and improve social skills. Another group will receive Group and Family-Based Cognitive Behavioral Therapy (GF-CBT-TH), which may delay or prevent the onset of psychosis and help improve relationships and daily activities. Additionally, some participants will receive Individual Cognitive Behavioral Therapy (I-CBT-TH). Early evidence suggests that telehealth delivery of CBT might enhance accessibility and participation, potentially boosting these positive effects. ^{1 2 6 7 8}

Who Is on the Research Team?

Yulia Landa

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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)

Meets criteria for psychosis-risk on SIPS

My medications have not changed in the last month.

Exclusion Criteria

Moderate or severe substance use disorder and active use within the past 30 days.

I have an intellectual disability with an IQ below 70.

I have a medical condition that can cause severe mental health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive telehealth-based Cognitive Behavioral Therapy interventions for 15 weeks, including Group and Family-Based CBT, Family-Based CBT, and Individual CBT.

15 weeks

15 family sessions, 15 individual sessions (telehealth)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collection at baseline, post-treatment, and 3-month follow-up.

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CBT Skills Group for CHR Youth
• CBT Skills Group for Families
• Individual CBT sessions

Trial Overview

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.

How Is the Trial Designed?

Group I: Group and Family-Based Cognitive Behavioral Therapy (GF-CBT-TH) Experimental Treatment 3 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 Treatment 2 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 Control 1 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.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Cognitive behavior therapy for psychosis (CBTp) shows beneficial effects on target symptoms, with an overall effect size of 0.400, indicating it can effectively address various symptoms like positive symptoms, negative symptoms, and social anxiety in patients with psychosis.

Methodological rigor significantly impacts the reported effectiveness of CBTp; trials that did not mask group allocation had inflated effect sizes, suggesting that careful study design is crucial for accurate assessment of treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for schizophrenia: effect sizes, clinical models, and methodological rigor. Wykes, T., Steel, C., Everitt, B., et al.[2023]

Group cognitive behaviour therapy for psychosis (GCBTp) significantly improves symptoms and self-esteem in individuals with early psychosis, as shown in a study of 66 participants over 3 months with assessments at baseline, post-treatment, and 6 months later.

The effectiveness of GCBTp is closely linked to the quality of the therapist alliance and group cohesion, particularly during challenging moments in therapy, highlighting the importance of interpersonal relationships in the therapeutic process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding process in group cognitive behaviour therapy for psychosis. Lecomte, T., Leclerc, C., Wykes, T., et al.[2022]

Cognitive Behavioral Therapy for psychosis (CBTp) showed significant improvements in psychosis symptoms, emotional problems, and life satisfaction after therapy, with effect sizes ranging from 0.44 to 0.75, based on a study of 358 clients over 12 years.

The benefits of CBTp were maintained at a 12-month follow-up for a subset of clients, indicating that the therapy has a potentially lasting positive impact, with a low drop-out rate of 13%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The long-term effectiveness of cognitive behavior therapy for psychosis within a routine psychological therapies service. Peters, E., Crombie, T., Agbedjro, D., et al.[2020]

Fifty clinicians in Northern California were trained in cognitive behavioral therapy for psychosis (CBTp), and 40 of them were evaluated, with 18 achieving competence over an average of 54 weeks, demonstrating that community clinicians can effectively learn this evidence-based practice.

The training process involved weekly consultations and tape reviews, but staff turnover posed challenges to sustaining the program, highlighting the need for strategies to maintain clinician engagement in early psychosis services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training early psychosis community clinicians in CBT for psychosis: Implementation and feasibility. Hardy, KV., Espil, FM., Smith, CL., et al.[2021]

This pilot randomized controlled trial (RCT) aims to assess the feasibility and acceptability of a crisis-focused Cognitive Behavioural Therapy for psychosis (CBTp) intervention specifically designed for an ethnically diverse group of 60 acute mental health inpatients.

The study is significant as it adapts the intervention in collaboration with stakeholders, including service users and clinicians, which may enhance its relevance and effectiveness in a real-world inpatient setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Crisis-focused Cognitive Behavioural Therapy for psychosis (CBTp) in acute mental health inpatient settings (the CRISIS study): protocol for a pilot randomised controlled trial. Wood, L., Williams, C., Pinfold, V., et al.[2022]

Many training directors in US psychiatry and psychology programs lack knowledge about the effectiveness of Cognitive-Behavioral Therapy for psychosis (CBTp), with only 50% of psychiatry and 40% of psychology directors recognizing its efficacy.

Training opportunities for CBTp are severely limited, with programs offering only a few hours of didactic and practical training, which is insufficient for effectively implementing CBTp in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Psychosis - Training Practices and Dissemination in the United States. Kimhy, D., Tarrier, N., Essock, S., et al.[2021]

Family focused therapy (FFT-CHR), an 18-session intervention, significantly improved family communication and reduced conflict among adolescents and young adults at clinical high risk for psychosis compared to a shorter 3-session enhanced care (EC) intervention, based on a study involving 66 participants.

Participants in FFT-CHR showed notable increases in constructive communication and active listening, along with decreases in irritability and criticism, indicating that this comprehensive family skills training can effectively enhance family dynamics in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of family focused therapy with populations at clinical high risk for psychosis: effects on interactional behavior. O'Brien, MP., Miklowitz, DJ., Candan, KA., et al.[2021]

This pilot study is the first to evaluate adaptations of Cognitive Behavioural Therapy (CBTpA) and Family Interventions (FIpA) specifically for adolescents with psychosis, involving 30 inpatient participants.

While the results did not reach conventional significance, CBTpA showed a promising effect size in reducing psychotic symptoms (d=0.6) compared to standard care alone, indicating that these therapies may be beneficial and acceptable for young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological interventions for adolescent psychosis: a pilot controlled trial in routine care. Browning, S., Corrigall, R., Garety, P., et al.[2020]

The feasibility study successfully recruited 70 individuals at-risk of developing psychosis and their family members, achieving 92% of the recruitment target, indicating that combined Individual and Family Cognitive Behavioural Therapy (IFCBT) can be effectively implemented.

The study aims to evaluate the effectiveness of IFCBT compared to standard treatment, with follow-ups at 6 and 12 months to assess outcomes such as transition to psychosis and improvements in mood and anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined individual and family therapy in comparison to treatment as usual for people at-risk of psychosis: A feasibility study (IF CBT): Trial rationale, methodology and baseline characteristics. Law, H., Izon, E., Au-Yeung, K., et al.[2021]

Group cognitive behavioural therapy for psychosis (CBTp) significantly improved delusions in patients with schizophrenia spectrum disorders, with 61% of participants showing at least a 50% reduction in delusion scores after treatment.

The study demonstrated that Group CBTp effectively reduced dysfunctional beliefs about voices and distress from positive psychotic symptoms, suggesting it can be a valuable addition to standard treatment in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy for Chinese patients with psychotic disorder: A feasibility controlled study. Wong, AWS., Ting, KT., Chen, EYH.[2019]

Individuals at Clinical High Risk (CHR) for psychosis may experience increased psychological distress during the COVID-19 pandemic, making early detection and intervention crucial.

Telepsychotherapy is a promising approach to support CHR individuals during the pandemic, but there is a need for evidence-based guidelines and best practices to effectively implement these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telepsychotherapy with Youth at Clinical High Risk for Psychosis: Clinical Issues and Best Practices during the COVID-19 Pandemic. DeLuca, JS., Andorko, ND., Chibani, D., et al.[2023]

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