Telehealth Cognitive Behavioral Therapy for High Risk of Psychosis
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Icahn School of Medicine at Mount Sinai
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.
12345Is 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.
15678How 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.
1791011Eligibility 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.Participant Groups
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.
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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Icahn School of Medicine at Mount SinaiNew York, NY
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
Psychological interventions for adolescent psychosis: a pilot controlled trial in routine care. [2020]Evidence for the recommendation to deliver Cognitive Behavioural Therapy (CBT) and Family Interventions (FI) to under-18s with psychosis derives from adult research, and no previous study has focused exclusively on an adolescent population. We evaluated adaptations of these therapies for adolescent inpatients with psychosis (CBTpA and FIpA), delivered as an adjunct to inpatient standard care (SC).
Understanding process in group cognitive behaviour therapy for psychosis. [2022]Group cognitive behaviour therapy for psychosis (GCBTp) has shown to be effective in diminishing symptoms, as well as in improving other psychosocial dimensions such as self-esteem. But little is known regarding the processes that generate these therapeutic improvements and might be harnessed to further improve its effectiveness.
The long-term effectiveness of cognitive behavior therapy for psychosis within a routine psychological therapies service. [2020]Randomised controlled trials (RCTs) have shown the efficacy of CBTp, however, few studies have considered its long-term effectiveness in routine services. This study reports the outcomes of clients seen in a psychological therapies clinic, set up following positive results obtained from an RCT (Peters et al., 2010). The aims were to evaluate the effectiveness of CBTp, using data from the service's routine assessments for consecutive referrals over a 12 years period, and assess whether gains were maintained at a 6+ months' follow-up. Of the 476 consenting referrals, all clients (N = 358) who received ≥5 therapy sessions were offered an assessment at four time points (baseline, pre-, mid-, and end of therapy) on measures assessing current psychosis symptoms, emotional problems, general well-being and life satisfaction. A sub-set (N = 113) was assessed at a median of 12 months after finishing therapy. Following the waiting list (median of 3 months) clients received individualized, formulation-based CBTp for a median number of 19 sessions from 121 therapists with a range of experience receiving regular supervision. Clients showed no meaningful change on any measure while on the waiting list (Cohen's d
Group cognitive behavioural therapy for Chinese patients with psychotic disorder: A feasibility controlled study. [2019]Evidence for the effectiveness of individual cognitive behavioural therapy for psychosis (CBTp) is promising but evidence for presenting CBTp in a group setting and in the Asian context is limited. The present study is to evaluate the feasibility and effectiveness of Group CBTp in clinical practice.
Training early psychosis community clinicians in CBT for psychosis: Implementation and feasibility. [2021]Cognitive behavioural therapy (CBT) has demonstrated efficacy for treating of psychotic symptoms and is recommended as an evidence-based practice (EBP) in early psychosis services. Despite this recommendation, there is limited information about the feasibility of training community clinicians, working in an early psychosis service, to competence in the delivery of this intervention.
Cognitive Behavioral Therapy for Psychosis - Training Practices and Dissemination in the United States. [2021]Cognitive-Behavioral Therapy for psychosis (CBTp) is an evidence-based treatment for psychosis-related disorders. However, despite the strong evidence-base and inclusion in national treatment guidelines, CBTp remains poorly disseminated in the US. It is proposed that this state is a product of lack of CBTp knowledge among clinical training leaders along with limited availability of training opportunities.
Cognitive behavior therapy for schizophrenia: effect sizes, clinical models, and methodological rigor. [2023]Guidance in the United States and United Kingdom has included cognitive behavior therapy for psychosis (CBTp) as a preferred therapy. But recent advances have widened the CBTp targets to other symptoms and have different methods of provision, eg, in groups.
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]Cognitive Behavioural Therapy for psychosis (CBTp) has an established evidence base and is recommended by clinical guidelines to be offered during the acute phases of psychosis. However, few research studies have examined the efficacy of CBTp interventions specifically adapted for the acute mental health inpatient context with most research trials being conducted with white European community populations.
Telepsychotherapy with Youth at Clinical High Risk for Psychosis: Clinical Issues and Best Practices during the COVID-19 Pandemic. [2023]Early detection and prevention of psychosis has become an international priority. Much of this work has focused on youth presenting with attenuated symptoms of psychosis-those at Clinical High Risk for psychosis (CHR)-given their elevated probability of developing the full disorder in subsequent years. Individuals at CHR may be prone to exacerbated psychological distress during the COVID-19 pandemic and its subsequent physical isolation measures, due to heightened stress sensitivity and comorbid mental health problems. Telepsychotherapy holds promise for reaching this population, especially during the current COVID-19 outbreak. However, there are limited evidence-based guidelines or interventions for use of telepsychotherapy with this population. In this paper, we review common clinical issues for individuals at CHR and how they might be exacerbated by the COVID-19 pandemic; best practices for treatment and adaptations for telepsychotherapy for individuals at CHR; and highlight real clinical issues that we are currently experiencing in a United States-based specialized CHR clinic as we conduct telepsychotherapy via videoconferencing. We conclude with questions for those in the field to contemplate, as well as potential challenges and benefits in using telepsychotherapy with individuals at CHR and their families.
A randomized trial of family focused therapy with populations at clinical high risk for psychosis: effects on interactional behavior. [2021]This study investigated whether family focused therapy (FFT-CHR), an 18-session intervention that consisted of psychoeducation and training in communication and problem solving, brought about greater improvements in family communication than enhanced care (EC), a 3-session psychoeducational intervention, among individuals at clinical high risk for developing psychosis.
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]Current National Institute for Health and Care Excellence (NICE) guidelines for psychosis recommend psychological therapy with or without family intervention for individuals at-risk of developing psychosis. NICE guidelines have a specific research recommendation to investigate the clinical and cost effectiveness of combined individual and family intervention. We report the rationale, design and baseline characteristics of a feasibility study which aimed to investigate combined Individual and Family Cognitive Behavioural Therapy (IFCBT) for those at-risk of developing psychosis.