Personalised Acceptance and Commitment Therapy (PACT) for Parkinson's Disease
| ISRCTN | ISRCTN65177345 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65177345 |
| Secondary identifying numbers | City, University of London ethics committee ETH2223-1570 |
- Submission date
- 02/08/2023
- Registration date
- 21/08/2023
- Last edited
- 27/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Living with Parkinson’s disease presents daily challenges, which can affect a person’s wellbeing. Face-to-face talking therapies are effective at improving wellbeing but can be time-consuming and difficult to access. The COVID-19 pandemic has reduced access to face-to-face support and expanded our digital world. Digital applications on smartphones and tablets are an effective way of delivering psychological support.
The aim of this study is to develop and test a digital application which provides brief daily support for psychological wellbeing based on the talking therapy Acceptance and Commitment Therapy (ACT). The application or app will provide 5-10 minute ‘bite-sized’ sessions. Using technology, the content will be tailored to meet each person’s needs. The application will teach coping skills that can be used long-term to support psychological wellbeing.
Who can participate?
Patients aged 18 years and over with Parkinson’s disease who need psychological support
What does the study involve?
Participants will be randomly allocated to be given access to the app for 4 weeks or to receive care and support as they usually would (they will receive the app at the end of the trial). The researchers will then compare the two groups on several aspects of wellbeing to see if using the app made a difference. They also want to know if the app is acceptable and may make further refinements based on people’s experience using it. All the questionnaires and interviews can be completed through online surveys or videocall.
What are the possible benefits and risks of participating?
It is unlikely that participants will experience any harm by taking part in the study and using the app. If using the app causes any discomfort, distress or concern, participants are free to stop or withdraw at any time. The researchers can also help share some resources or contact the neurology team for any further assistance.
It is hoped that using the app and learning some of the tools and activities can help participants manage any emotional struggles they may have and help with their wellbeing. If this app is effective, the researchers hope to roll it out so that other people with Parkinson’s may also benefit from it. They also hope that participants will find it interesting to take part and learn of the results.
Where is the study run from?
City, University of London (UK)
When is the study starting and how long is it expected to run for?
June 2023 to April 2024
Who is funding the study?
Parkinson’s UK
Who is the main contact?
Cathryn Pinto, cathryn.pinto@city.ac.uk
Contact information
Public
School of Health and Psychological Sciences
City, University of London
1 Myddelton Street
London
EC1R 1UW
United Kingdom
 ORCID ID |
0000-0001-7607-7192 |
|---|---|
| Phone | +44 (0)20 7040 4041 |
| cathryn.pinto@city.ac.uk |
Scientific
School of Health and Psychological Sciences
City, University of London
Northampton Square
London
EC1V 0HB
United Kingdom
| Phone | +44 (0)20 7040 8532 |
|---|---|
| Angeliki.Bogosian.1@city.ac.uk |
Principal Investigator
School of Health and Psychological Sciences
City, University of London
Northampton Square
London
EC1V 0HB
United Kingdom
| Phone | +44 (0)20 7040 8532 |
|---|---|
| Angeliki.bogosian.1@city.ac.uk |
Study information
| Study design | Parallel-group randomized controlled feasibility trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, Home |
| Study type | Quality of life, Treatment, Efficacy |
| Participant information sheet | 44050_PIS_v3.pdf |
| Scientific title | Acceptability and feasibility randomized controlled trial of a digital psychological support intervention for people with Parkinson’s disease |
| Study acronym | PACT-am |
| Study hypothesis | A psychological support app based on Acceptance and Commitment Therapy (ACT) is acceptable to people with Parkinson's disease. It is feasible to conduct a randomized controlled trial to assess the effectiveness and cost-effectiveness of a psychological support app for Parkinson's disease. |
| Ethics approval(s) |
Approved 15/08/2023, City Research Ethics Online, City University of London (Northampton Square, London, EC1V 0HB, United Kingdom; Not available; SenateREC@city.ac.uk), ref: ETH2223-1570 |
| Condition | Parkinson's disease |
| Intervention | The intervention is a digital app that contains sessions based on Acceptance and Commitment Therapy (ACT). Randomisation will follow a 2:1 ratio stratified by disease duration and baseline levels of psychological distress, using fixed block sizes. Participants will be randomized into two groups (2:1 - 40 participants in the intervention group and 20 participants in the control group). The intervention group will be able to access this app online where it will be available for 4 weeks. The control group is a waitlist control group who will receive usual care for 4 weeks followed by the offer to use the app if they choose to. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Recruitment and retention rate: proportion of people identified as eligible after screening, proportion of eligible people randomized and consented to the study, proportion of people who completed the baseline and end-point assessments 2. Intervention engagement: number of times logged on to the app and number of sessions completed during the 4-week trial period 3. Intervention acceptability measured by a questionnaire and interviews based on the Theoretical Framework of Acceptability domains at the end of the trial period |
| Secondary outcome measures | 1. Depression measured using the PHQ-9 at 4 weeks 2. Anxiety measured using the GAD-7 at 4 weeks 3. Quality of life measured by the PDQ-8 at 4 weeks 4. Acceptance and commitment therapy processes measured by the AAQ-2, Experiences questionnaire and CAQ-8 at 4 weeks 5. Healthcare utilisation measured by the Client service receipt inventory (CSRI) at baseline and 4 weeks |
| Overall study start date | 01/06/2023 |
| Overall study end date | 30/04/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Participant inclusion criteria | 1. Aged 18 years and above 2. Self-reported diagnosis of Parkinson's 3. Lives in the UK 4. Has access to computer/tablet/smartphone and the internet 5. Is able to read and communicate in English 6. Be stable on anti-depressants or anxiolytics if taken- stable dose for a minimum of 1 month 7. Mild-to-moderate levels of distress determined by a score between 3-8 on the PHQ4 |
| Participant exclusion criteria | 1. Severe cognitive impairment as determined by a score of 20 or above on the 6-item Cognitive Impairment Test (Katzman, Brown & Fuld, 1983) 2. Psychiatric conditions (e.g., psychosis, drug/ alcohol addiction) that can potentially risk failure in the treatment or limit participation in the course |
| Recruitment start date | 01/09/2023 |
| Recruitment end date | 01/03/2024 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centre
215 Vauxhall Bridge Road
London
SW1V 1EJ
United Kingdom
Sponsor information
University/education
Northampton Square
London
EC1V 0HB
England
United Kingdom
| Phone | +44 (0)20 7040 5060 |
|---|---|
| SenateREC@city.ac.uk | |
| Website | http://www.city.ac.uk |
"ROR" |
https://ror.org/04489at23 |
Funders
Funder type
Charity
Private sector organisation / Associations and societies (private and public)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/04/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a high impact journal |
| IPD sharing plan | The anonymised datasets generated during/or analysed during the current study will be stored in a publicly available repository (Open Science Framework https://osf.io/ or Health Open Research https://healthopenresearch.org/parkinsonsuk) The type of data stored is datasheets with anonymised quantitative data about trial outcomes, acceptability and satisfaction, and anonymised interview transcripts around intervention experience and acceptability. These data will be available after the publication of papers using this data, with no expiration date. Consent from participants was required and obtained. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3 | 01/08/2023 | 09/08/2023 | No | Yes |
| Results article | 26/03/2025 | 27/03/2025 | Yes | No |
Additional files
Editorial Notes
27/03/2025: Publication reference added.
15/09/2023: Study website and ethics approval details added.
09/08/2023: Trial's existence confirmed by Parkinson's UK.
