Pilot and Feasibility Studies (Mar 2025)

Acceptability and feasibility randomised controlled trial of a digital mental health intervention for people with Parkinson’s (PACT): trial protocol

  • Cathryn Pinto,
  • Jennie Brown,
  • Catherine Hurt,
  • Patricia Cubi-Molla,
  • Sulayman Chowdhury,
  • Lance McCracken,
  • Sam Norton,
  • Ricardo Volpato,
  • Simone Stumpf,
  • Angeliki Bogosian

DOI
https://doi.org/10.1186/s40814-025-01594-9
Journal volume & issue
Vol. 11, no. 1
pp. 1 – 12

Abstract

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Abstract Background People with Parkinson’s disease can experience psychological distress and have difficulties accessing face-to-face psychological support due to symptom burden and limited availability of psychological services. Digital options for psychological support can bridge this gap. We have developed an app based on acceptance and commitment therapy (ACT) to support people with Parkinson’s to improve psychological wellbeing. Aim To assess the acceptability of the app and the feasibility of conducting a randomised controlled trial (RCT) to evaluate the effectiveness of using the app to improve wellbeing for people with Parkinson’s. Methods We will conduct a parallel-group randomised controlled feasibility trial comparing a digital app based on ACT (intervention group) to usual care (waitlist control group). We will recruit 60 people with Parkinson’s, 40 to the intervention group and 20 to the control group. Primary feasibility outcomes include recruitment and retention rate, intervention engagement and satisfaction. Secondary outcomes include measures of clinical effectiveness (anxiety and depression), quality of life and cost-effectiveness. Interviews will be conducted to assess acceptability of the app. Primary feasibility outcome data will be analysed descriptively and compared against pre-defined feasibility criteria. Secondary outcomes will be analysed based on an intention-to-treat principle, and a cost-consequence analysis will be used to estimate cost-effectiveness. Interviews will be analysed using a deductive thematic analysis based on the Theoretical Framework of Acceptability. Discussion This trial will provide data on the feasibility of conducting a full-scale RCT of the effectiveness and cost-effectiveness of the app to improve psychological wellbeing for people with Parkinson’s disease.

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