Effects of Actissist, a digital health intervention for early psychosis: A randomized clinical trial.

Sandra Bucci, Natalie Berry, John Ainsworth, Katherine Berry, Dawn Edge, Emily Eisner, Richard Emsley, Gordon Forbes, Lamiece Hassan, Shôn Lewis, Matthew Machin, Gillian Haddock

Research output: Contribution to journalArticlepeer-review

Abstract

Schizophrenia affects 24 million people worldwide. Digital health interventions drawing on psychological principles have been developed, but their effectiveness remains unclear. This parallel, assessor-blinded, randomized clinical trial aimed to investigate whether a cognitive behaviour therapy-informed digital health intervention (Actissist app) confers added benefit on psychotic symptoms over and above remote symptom monitoring (ClinTouch app). Participants recruited from UK community health services were randomized 1:1 to receive either Actissist plus treatment as usual (TAU) or ClinTouch plus TAU. Eligible participants were adults with schizophrenia-spectrum psychosis within five years of first episode onset meeting a criterion level of positive symptoms severity. The primary outcome was Positive and Negative Syndrome Scale (PANSS) symptoms total score at 12 weeks post-randomization. Intention-to-treat analysis included 172 participants, with 149 participants (86.6%) providing primary outcome data. Actissist plus TAU was not associated with greater reduction than an active control remote symptom monitoring app (ClinTouch) in PANSS total score at post-randomization. There were no significant effects between groups across secondary measures. There were no serious adverse reactions. Both groups improved on the primary psychotic symptoms measure at primary end-point and on secondary measures over time. The Actissist app is safe but not superior to digital symptom monitoring.

Original languageEnglish
Article number116025
JournalPsychiatry Research
Volume339
Early online date11 Jun 2024
DOIs
Publication statusE-pub ahead of print - 11 Jun 2024

Keywords

  • Smartphone
  • Cognitive Behavioral Therapy
  • mobile applications
  • schizophrenia
  • ecological momentary assessment
  • digital medicine
  • mHealth

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