Process Evaluation of Digital Mental Health Interventions for Psychosis: Scoping Review With Framework Synthesis

Clinical Snapshot

Key Findings

• Effect Size: Not applicable — qualitative scoping review; no quantitative effect sizes reported or pooled

• Primary Outcome: Qualitative synthesis of process evaluation data across 14 DMHIs and 45 papers generated five MRC framework-aligned themes: (1) implementation strategies to enhance fit and support delivery; (2) variable implementation across users, staff, and settings; (3) mechanisms involving more helpful user responses; (4) contextual factors including treatment needs, preferences, everyday demands, and staff availability; (5) limited impact of user characteristics on DMHI outcomes

• Nnt Or Sensitivity: Not applicable for this study design; the review identifies contextual and implementation moderators rather than quantifying therapeutic effect. Notably, use of DMHIs 'varied between individuals', suggesting heterogeneous engagement that would translate to variable NNT estimates in future meta-analyses

• Confidence Interval: Not applicable — narrative synthesis only; no statistical confidence intervals generated

Clinical Application

The review provides preliminary support for the feasibility of delivering DMHIs to people with psychosis within trial settings, with the important caveat that engagement is variable. Key implementation enablers identified include: tailoring DMHIs to individual treatment needs and preferences, ensuring adequate staff availability for blended (human-supported digital) delivery models, and addressing everyday contextual demands that compete with DMHI engagement. Clinicians should anticipate heterogeneous uptake and plan for supported implementation rather than assuming autonomous digital engagement. Australian relevance is moderate-to-high. The UK NHS community mental health infrastructure closely parallels Australian public mental health services, including headspace and EPPIC/Orygen early psychosis models. Several DMHIs evaluated in the included trials (e.g., those developed at King's College London and related UK institutions) have been or are being evaluated in Australian contexts. The TGA does not currently have a specific regulatory pathway for Software as a Medical Device (SaMD) in mental health equivalent to the FDA's De Novo pathway, though the TGA's 2021 SaMD guidance is relevant. No DMHI for psychosis is currently listed on the PBS. RACGP guidelines on digital health (2023) support clinician-facilitated digital tool use but do not specifically endorse any DMHI for psychosis. Australian clinicians should note that the evidence base is predominantly UK-derived and that local implementation pilots with process evaluation components are needed before widespread adoption. Adults with established psychosis (schizophrenia spectrum and related disorders) who are engaged with secondary mental health services and being considered for adjunctive digital mental health interventions. The evidence base is predominantly from UK NHS early intervention and community mental health team settings, which are most directly applicable to similar publicly funded mental health services.

Abstract

BACKGROUND: Implementing digital mental health interventions (DMHI) for those with psychosis is a persistent challenge. A process evaluation, or studies conducted alongside trials, is one research method that may address this issue. However, a synthesis of process evaluation data in this area is missing. OBJECTIVE: This study aimed to understand what is known about context, implementation, and mechanisms of impact by synthesizing process evaluation data from trials evaluating DMHIs used by people with psychosis. METHODS: A scoping review using a 2-phase search strategy underpinned by the Medical Research Council (MRC) process evaluation framework was conducted. Database searches of Cochrane Central Register of Controlled Trials and PsycInfo in 2024 and 2025 first identified an index sample of peer-reviewed trials predominantly conducted in the United Kingdom (≥50% of samples from the United Kingdom in multicountry studies). Next, papers linked to the index sample were retrieved and included if they reported process evaluation data as operationalized in the MRC framework. Two authors independently screened references, extracted summary data, and assessed the quality of index trials. One author qualitatively synthesized process evaluation data using a deductive framework synthesis approach using the MRC framework. Findings were triangulated with senior authors and presented as a narrative synthesis. RESULTS: Searches identified 14 DMHIs and 45 papers reporting process evaluation data, though only 2 were labeled as such. Qualitative syntheses of process evaluation data generated five themes aligned with the MRC framework: (1) enhancing fit and supporting delivery (implementation strategies); (2) DMHI implementation varied across users, staff, and delivery settings (implementation outcomes); (3) helping users to respond in more helpful ways (mechanisms); (4) addressing perceived and actual implementation factors (context); and (5) limited impact of user characteristics on DMHI outcomes (context). CONCLUSIONS: There is preliminary evidence that DMHIs can be delivered to people experiencing psychosis within trial settings, although use varied between individuals. Future implementation efforts may benefit from addressing contextual factors influencing DMHI use, including users' treatment needs and preferences, everyday demands, and staff availability for blended interventions. Future research could evaluate implementation strategies, validate how and for whom DMHIs work, and embed process evaluation in trials. TRIAL REGISTRATION: PROSPERO CRD42024439117; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024439117.