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Efficacy Data from a Randomised Control Trial Evaluating a Digital Mental Health Support Intervention for People with Parkinson’s, 2023-2024
Creator
Bogosian, A, City, University of London
Study number / PID
857427 (UKDA)
10.5255/UKDA-SN-857427 (DOI)
Data access
Open
Series
Not available
Abstract
We developed a web application (PACT app) based on Acceptance and Commitment Therapy (ACT) to support mental health for people with Parkinson’s. Here, we assess the acceptability of the PACT app and the feasibility of conducting a randomised controlled trial to evaluate the effectiveness of using the app.
This was a two-armed parallel groups design with 2:1 allocation to the PACT app or waiting-list control and a single, post-intervention follow-up. Feasibility outcomes included recruitment and retention rate, intervention engagement and satisfaction. Secondary outcomes included measures of anxiety, depression, quality of life, and cost-effectiveness. Intention-to-treat principle was used for secondary outcomes analysis. Treatment effects were estimated using linear regression.
Fifty-seven people with Parkinson’s reporting mild or moderate psychological distress were randomised to 4 weeks of an ACT based app (n=38) or waiting-list control (n=19). Recruitment, retention rate, intervention use, and acceptability met our progression criteria. Intervention effects were largest for measures of depression (Hedges g = -0.96) and committed action (Hedges g = 0.87) and in the expected direction for all other outcome measures.
PACT is acceptable to people with Parkinson’s and with efficacy signal. A future larger trial to fully evaluate efficacy is needed.Objectives. We developed a web application (PACT app) based on Acceptance and Commitment Therapy (ACT) to support mental health for people with Parkinson’s. Here, we assess the acceptability of the PACT app and the feasibility of conducting a randomised controlled trial to evaluate the effectiveness of using the app.
Methods. This was a two-armed parallel groups design with 2:1 allocation to the PACT app or waiting-list control and a single, post-intervention follow-up. Feasibility outcomes included recruitment and retention rate, intervention engagement and satisfaction. Secondary outcomes included measures of...
Terminology used is generally based on DDI controlled vocabularies: Time Method, Analysis Unit, Sampling Procedure and Mode of Collection, available at CESSDA Vocabulary Service.
Methodology
Data collection period
01/10/2023 - 01/02/2024
Country
United Kingdom
Time dimension
Not available
Analysis unit
Individual
Universe
Not available
Sampling procedure
Not available
Kind of data
Numeric
Data collection mode
This was a two-armed parallel-group, randomised controlled feasibility trial comparing a digital app based on ACT (intervention group) to usual care (waitlist control group). Randomisation followed a 2:1 ratio stratified by, disease duration, and baseline levels of psychological distress, using fixed block sizes to maintain an equal allocation ratio throughout recruitment. A randomisation list was generated using Sealed Envelop the online service. This was administered by AB to maintain allocation concealment at the point of randomisation. Given the nature of the study it was not possible to blind participants or researchers to group allocation. All participants were asked to complete online questionnaires at baseline and at 4 weeks post-randomisation when those in the control group were expected to have completed the intervention. Participants were included if they were over 18 years of age, self-reported a diagnosis of Parkinson's, lived in the UK, had access to computer/tablet/smartphone and the internet, were able to read and communicate in English, were stable on anti-depressants or anxiolytics if taken- stable dose for a minimum of 1 month and had mild-to-moderate levels of distress determined by a score between 3-8 on the PHQ-4. Participants with severe cognitive impairment as determined by a score of 20 or above on the 6-item Cognitive Impairment Test (Katzman et al., 1983) or psychiatric conditions (e.g., psychosis, drug/ alcohol addiction) that can potentially risk failure in the treatment or limit participation in the course, were excluded.We recruited participants through the Parkinson’s UK research support network via newsletters, social media, and local groups. Interested PwP were then contacted a member of the research team who answered any questions and screened potential participants over the phone. Those who were not eligible were provided with additional information and resources where appropriate. Eligible participants were emailed the participant information sheet and links to complete the consent form and baseline questionnaire.
Funding information
Grant number
H-2102
Access
Publisher
UK Data Service
Publication year
2025
Terms of data access
The Data Collection is available to any user without the requirement for registration for download/access.