Efficacy Data from a Randomised Control Trial Evaluating a Digital Mental Health Support Intervention for People with Parkinson’s, 2023-2024

Bogosian, Angeliki (2025). Efficacy Data from a Randomised Control Trial Evaluating a Digital Mental Health Support Intervention for People with Parkinson’s, 2023-2024. [Data Collection]. Colchester, Essex: UK Data Service. 10.5255/UKDA-SN-857427

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 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.
Results: 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.
Conclusions: PACT is acceptable to people with Parkinson’s and with an efficacy signal. A future larger trial to fully evaluate efficacy is needed.

Data description (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.

Data creators:

Creator Name	Affiliation	ORCID (as URL)
Bogosian Angeliki	City, University of London

Sponsors:

Parkinson's UK

Grant reference:

H-2102

Topic classification:

Health
Demography (population, vital statistics and censuses)
Psychology

Keywords:

MENTAL HEALTH, AGEING, PSYCHOLOGICAL WELL-BEING, TECHNOLOGY AND INNOVATION, HEALTH

Project title:

Evaluating a digital mental health support intervention for people with Parkinson’s (PACT): acceptability and feasibility randomised controlled trial

Alternative title:

PACT

Grant holders:

Angeliki Bogosian, City St George's, University of London, Sam Norton, King's College London, Patricia Cubi-Molla, Office of Health Economics, Catherine Hurt, City St George's, University of London, Simone Stumpf, University of Glasgow, Lance McCracken, Uppsala University

Project dates:

From	To
February 2021	August 2024

Date published:

03 Jan 2025 13:16

Last modified:

03 Jan 2025 13:17

Coverage and Methodology

Collection period:

Date from:	Date to:
October 2023	February 2024

Geographical area:

Country:

United Kingdom

Spatial unit:

No Spatial Unit

Data collection method:

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.

Observation unit:

Individual

Kind of data:

Numeric

Type of data:

Cohort and longitudinal studies

Resource language:

English

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