BackgroundTimely access to intervention for psychosis is crucial yet problematic. As such, health care providers are forming digital strategies for addressing mental health challenges. A theory-driven digital intervention that monitors distressing experiences and provides real-time active management strategies could improve the speed and quality of recovery in psychosis, over and above conventional treatments. This study assesses the feasibility and acceptability of Actissist, a digital health intervention grounded in the cognitive model of psychosis that targets key early psychosis domains.MethodsA proof-of-concept, single, blind, randomized controlled trial of Actissist, compared to a symptom-monitoring control. Thirty-six early psychosis patients were randomized on a 2:1 ratio to each arm of the trial. Actissist was delivered via a smartphone app over 12-weeks; clinical and functional assessment time-points were baseline, post-treatment and 22-weeks. Assessors’ blind to treatment condition conducted the assessments. Acceptability was examined using qualitative methods.ResultsActissist was feasible (75% participants used Actissist at least once/day; uptake was high, 97% participants remained in the trial; high follow-up rates), acceptable (90% participants recommend Actissist), and safe (0 serious adverse events), with high levels of user satisfaction. Treatment effects were large on negative symptoms, general psychotic symptoms and mood. The addition of Actissist conferred benefit at post-treatment assessment over routine symptom-monitoring and treatment as usual.ConclusionsThis is the first controlled proof-of-concept trial of a theory-driven digital health intervention for early psychosis. Actissist is feasible and acceptable to early psychosis patients, with a strong signal for treatment efficacy.Trial Registration: ISRCTN: 34966555.

Background: Digital health products designed to help people with severe mental health problems appear to be feasible, acceptable, and efficacious. The challenge facing the digital mental health field is implementing digital tools in routine service delivery. To date, there has been a paucity of qualitative research exploring staff views of digital health solutions in the context of mental healthcare. Engaging and involving frontline staff in the design and rollout of new technology to improve utilization is imperative for successful uptake and adoption of digital tools. The aim of the current study is to explore frontline staff views regarding the utility and appropriateness of using digital tools in the healthcare pathway for people accessing specialist secondary care mental health services. Method: Qualitative study using framework analysis was used with 48 mental health staff working in early intervention for psychosis services. Six groups comprising 5–10 early intervention service staff members in each group were conducted across the Northwest of England. Robust measures were used to develop a stable framework, including member checking, triangulation, and consensus meetings. Results: Three themes were identified a priori : i) perceived barriers to adopting smartphone apps for early psychosis; ii) acceptability of digital health tools for early psychosis patients; and iii) data security, safety, and risk. Alongside exploring the a priori topics, one theme was generated a posteriori : iv) relationships. Conclusions: Staff working in specialist early intervention for psychosis services found digital tools on the whole acceptable in mental health service provision, but raised a number of concerns that will likely affect implementation of such systems into routine service delivery and practice. Thirteen recommendations are made in this paper as a result of the themes generated in these data. Implementing of digital systems needs to be simple and uncomplicated and improve clinical workflows for staff rather than hinder and increase clinical workflows. Furthermore, organizational support with a clear plan for implementing technological innovations is required for successful adoption of digital systems. Consideration of staff views around digital systems is important if successful adoption and implementation of such systems are to occur. Clinical Trial Registration: , identifier ISRCTN34966555.

BackgroundDigital health interventions in the form of smartphone apps aim to improve mental health and enable people access to support as and when needed without having to face the stigma they may experience in accessing services. If we are to evaluate mobile health (mHealth) apps and advance scientific understanding, we also need tools to help us understand in what ways mHealth interventions are effective or not. The concept of therapeutic alliance, a measure of the quality of the relationship between a health care provider and a service user, is a key factor in explaining the effects of mental health interventions. The Agnew Relationship Measure (ARM) is a well-validated measure of therapeutic alliance in face-to-face therapy.ObjectiveThis study presented the first attempt to (1) explore service users’ views of the concept of relationship within mHealth mental health interventions and (2) adapt a well-validated face-to-face measure of therapeutic alliance, the Agnew Relationship Measure (ARM), for use with mHealth interventions.MethodsIn stage 1, we interviewed 9 mental health service users about the concept of therapeutic alliance in the context of a digital health intervention and derived key themes from interview transcripts using thematic analysis. In stage 2, we used rating scales and open-ended questions to elicit views from 14 service users and 10 mental health staff about the content and face validity of the scale, which replaced the word “therapist” with the word “app.” In stage 3, we used the findings from stages 1 and 2 to adapt the measure with the support of a decision-making algorithm about which items to drop, retain, or adapt.ResultsFindings suggested that service users do identify relationship concepts when thinking about mHealth interventions, including forming a bond with an app and the ability to be open with an app. However, there were key differences between relationships with health professionals and relationships with apps. For example, apps were not as tailored and responsive to each person’s unique needs. Furthermore, apps were not capable of portraying uniquely human-like qualities such as friendliness, collaboration, and agreement. We made a number of changes to the ARM that included revising 16 items; removing 4 items due to lack of suitable alternatives; and adding 1 item to capture a key theme derived from stage 1 of the study (“The app is like having a member of my care team in my pocket”).ConclusionsThis study introduces the mHealth version of the ARM, the mARM, that has good face and content validity. We encourage researchers to include this easy-to-use tool in digital health intervention studies to gather further data about its psychometric properties and advance our understanding of how therapeutic alliance influences the efficacy of mHealth interventions.Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN) 34966555; http://www.isrctn.com/ISRCTN34966555 (Archived by WebCite at http://www.webcitation.org/6ymBVwKif)