JMIR Publications

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:

To explore 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 mixed–method systematic review using a two–phase search strategy underpinned by the Medical Research Council (MRC) process evaluation framework was conducted. Database searches of CENTRAL and PsycInfo in 2024 and 2025 first identified an index sample of peer–reviewed trials predominantly conducted in the United Kingdom (50≥% United Kingdom sample in multi–country 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 two were labelled as such. Qualitative syntheses of process evaluation data generated five themes aligned with the MRC framework: (1) variation in how DMHIs were used in RCTs (implementation); (2) enabling implementation: resource preparation and supporting users (implementation); (3) helping users to respond in more helpful ways (mechanisms); (4) addressing perceived and actual implementation factors (context); (5) limited impact of user characteristics on DMHI outcomes (context).

Conclusions:

Our findings highlight considerations for future DMHI development, delivery and evaluation. Practical delivery considerations include addressing actual contextual factors (users’ treatment needs and preferences, everyday and clinical factors, and staff availability for blended DMHIs), personalizing professional support and facilitating user access to necessary technology. Conceptual design considerations include embedding content personalization, flexible delivery and user–centered design in DMHIs. Research efforts could focus on validating how and for whom DMHIs work and embedding process evaluation in trials. Clinical Trial: PROSPERO: CRD42024439117.