Journal
SCHIZOPHRENIA BULLETIN
Volume 44, Issue 5, Pages 1070-1080Publisher
OXFORD UNIV PRESS
DOI: 10.1093/schbul/sby032
Keywords
psychosis; relapse; mHealth; digital intervention; randomized controlled trial; early psychosis
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Funding
- Medical Research Council Developmental Pathway Funding Scheme [MR/L005301/1]
- University of Manchester
- Greater Manchester Mental Health NHS Foundation Trust
- MRC [MR/L005301/1, MR/P026664/1] Funding Source: UKRI
- Medical Research Council [MR/L005301/1] Funding Source: researchfish
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Background: Timely 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. Methods: A 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. Results: Actissist 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. Conclusions: This 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.
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