Summary information

Study title

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...
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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.

Related publications

Not available