In an ambitious effort to tackle the rising challenge of psychiatric hospital admissions among individuals with serious mental health problems (SMHP), a multi-stage, multi-arm randomised controlled trial (RCT) is being conducted across five UK sites. The trial aims to evaluate the clinical and cost-effectiveness of three innovative psychosocial treatments, compared to conventional treatment as usual (TAU). The significance of this study lies in its potential to offer scalable and sustainable solutions through remote interventions, which are crucial in a pandemic or national crisis context.
Innovative Psychosocial Treatments
The trial consists of four arms conducted over two stages, focusing on individuals who have recently experienced a suicidal crisis. The primary goal is to determine the impact of these treatments on reducing psychiatric hospital admissions over a six-month period. The interventions include structured peer support (PREVAIL), a safety planning approach delivered by assistant psychologists (SAFETEL), and a Cognitive Behavioral Therapy (CBT)-based suicide prevention app called BrighterSide. These treatments aim to reduce suicidal thoughts and behaviors, foster hope, aid recovery, and alleviate anxiety and depression.
Trial Structure and Randomization
The trial’s randomisation process began with a ratio of 1:1:1:2 in favor of TAU. However, following the release of efficacy data from an independent RCT, the BrighterSide arm was removed, prompting an amendment to a 2:2:3 ratio. Randomisation is performed through an independent web-based system, stratified by site, ensuring unbiased allocation. An interim analysis will be conducted with data from the first 385 participants, which will influence the continuation of specific arms in stage 2. The expected total sample size is 1064 participants, inclusive of those initially in the BrighterSide arm.
The relevance of this study extends to market access, as it explores the feasibility and scalability of these interventions. By demonstrating cost-effectiveness and clinical benefits, the treatments could gain favorable positions in mental health care markets, potentially easing the burden on psychiatric facilities and reducing healthcare costs.
The study’s focus on remote delivery aligns with current healthcare trends towards telehealth and digital health solutions. This approach not only ensures accessibility for patients regardless of their location but also aligns with market demands for flexible and scalable mental health solutions.
Key Inferences
- Structured peer support (PREVAIL) has potential market appeal due to its peer-driven model, which can be cost-effective and relatable to patients.
- SAFETEL’s safety planning approach, delivered by assistant psychologists, offers a structured yet personalized intervention that can be easily integrated into existing mental health services.
- The removal of the BrighterSide app highlights the importance of continuous efficacy evaluation, crucial for market success and regulatory approval.
The trial’s findings could significantly influence mental health treatment practices, offering evidence-based alternatives to psychiatric admissions. The potential market for these interventions is vast, given the global rise in mental health issues and the urgent need for effective, accessible treatments.
Original Article:
Trials. 2024 Jul 6;25(1):460. doi: 10.1186/s13063-024-08293-5.
ABSTRACT
BACKGROUND: People with serious mental health problems (SMHP) are more likely to be admitted to psychiatric hospital following contact with crisis services. Admissions can have significant personal costs, be traumatic and are the most expensive form of mental health care. There is an urgent need for treatments to reduce suicidal thoughts and behaviours and reduce avoidable psychiatric admissions.
METHODS: A multi-stage, multi-arm (MAMS) randomised controlled trial (RCT) with four arms conducted over two stages to determine the clinical and cost effectiveness of three psychosocial treatments, compared to treatment as usual (TAU), for people with SMHP who have had recent suicidal crisis. Primary outcome is any psychiatric hospital admissions over a 6-month period. We will assess the impact on suicidal thoughts and behaviour, hope, recovery, anxiety and depression. The remote treatments delivered over 3 months are structured peer support (PREVAIL); a safety planning approach (SAFETEL) delivered by assistant psychologists; and a CBT-based suicide prevention app accessed via a smartphone (BrighterSide). Recruitment is at five UK sites. Stage 1 includes an internal pilot with a priori progression criteria. In stage 1, the randomisation ratio was 1:1:1:2 in favour of TAU. This has been amended to 2:2:3 in favour of TAU following an unplanned change to remove the BrighterSide arm following the release of efficacy data from an independent RCT. Randomisation is via an independent remote web-based randomisation system using randomly permuted blocks, stratified by site. An interim analysis will be performed using data from the first 385 participants from PREVAIL, SAFETEL and TAU with outcome data at 6 months. If one arm is dropped for lack of benefit in stage 2, the allocation ratio of future participants will be 1:1. The expected total sample size is 1064 participants (1118 inclusive of BrighterSide participants).
DISCUSSION: There is a need for evidence-based interventions to reduce psychiatric admissions, via reduction of suicidality. Our focus on remote delivery of established brief psychosocial interventions, utilisation of different modalities of delivery that can provide sustainable and scalable solutions, which are also suitable for a pandemic or national crisis context, will significantly advance treatment options.
TRIAL REGISTRATION: ISRCTN33079589. Registered on June 20, 2022.
PMID:38971788 | DOI:10.1186/s13063-024-08293-5
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