Telehealth Cognitive Behavioral Therapy for High Risk of Psychosis

Recruiting in Palo Alto (17 mi)

Overseen by Yulia Landa

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Telehealth Cognitive Behavioral Therapy for High Risk of Psychosis?

Research shows that Cognitive Behavioral Therapy for psychosis (CBTp) is effective in reducing symptoms and improving well-being, both in individual and group settings. Studies have demonstrated its success in various contexts, suggesting that similar approaches, like telehealth CBT, could also be beneficial. ^{1 2 3 4 5}

Is telehealth cognitive behavioral therapy for high risk of psychosis safe for humans?

Cognitive Behavioral Therapy for psychosis (CBTp) is considered safe and is recommended by clinical guidelines for treating psychosis-related disorders, including in acute phases and for adolescents, based on its established evidence base. ^{1 5 6 7 8}

How is the Telehealth Cognitive Behavioral Therapy for High Risk of Psychosis treatment different from other treatments for this condition?

This treatment is unique because it combines individual and family-based cognitive behavioral therapy (CBT) delivered via telehealth, which is particularly beneficial for reaching youth at high risk of psychosis during times of physical isolation, such as the COVID-19 pandemic. It focuses on early detection and prevention, addressing both individual and family dynamics, which is not commonly emphasized in standard treatments. ^{1 7 9 10 11}

Research Team

Yulia Landa

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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)

My medications have not changed in the last month.

I am between 14 and 25 years old.

Exclusion Criteria

I have an intellectual disability with an IQ below 70.

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

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

Trial Timeline

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

Treatment Details

Interventions

• CBT Skills Group for CHR Youth (Behavioural Intervention)
• CBT Skills Group for Families (Behavioural Intervention)
• Individual CBT sessions (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Psychological interventions for adolescent psychosis: a pilot controlled trial in routine care. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Understanding process in group cognitive behaviour therapy for psychosis. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The long-term effectiveness of cognitive behavior therapy for psychosis within a routine psychological therapies service. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy for Chinese patients with psychotic disorder: A feasibility controlled study. [2019]

5. Australia pubmed.ncbi.nlm.nih.gov

Training early psychosis community clinicians in CBT for psychosis: Implementation and feasibility. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Psychosis - Training Practices and Dissemination in the United States. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for schizophrenia: effect sizes, clinical models, and methodological rigor. [2023]

8. England 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Telepsychotherapy with Youth at Clinical High Risk for Psychosis: Clinical Issues and Best Practices during the COVID-19 Pandemic. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of family focused therapy with populations at clinical high risk for psychosis: effects on interactional behavior. [2021]

11. Australia 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. [2021]