Mental Health Support for People Affected by Parkinson's

NCT06992869 | Completed

• 2 other identifiers: 157987H-2202
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

In addition to increasingly severe physical symptoms, Parkinson's can cause distressing mental health issues. These include anxiety, depression, and memory and thinking problems, caused by a combination of biological and psychological factors. They can be more disabling than physical symptoms, reduce quality of life and increase risk of mortality. They are also upsetting for family members and unpaid carers, and may necessitate transfer to institutional care. They also increase NHS costs because of expensive hospital admissions. Despite this, there are few specialist mental health professionals or psychological interventions available to help people with Parkinson's. This study will address this by developing an effective programme of evidence-based psychological interventions for mental health issues in Parkinson's that can be easily delivered by non-experts. Parkinson's mental health specialists at UCL Queen Square Institute of Neurology will work with people affected by Parkinson's and non-psychology health professionals to design specialist interventions for three key mental health needs in Parkinson's, targeted at distinct stages:

1. 1.Adjusting to diagnosis; empowering people to feel more in control.
2. 2.Anxiety and/or depression; using cognitive-behavioural therapy techniques to improve mood, with particular focus on Parkinson's-specific concerns.
3. 3.Advanced Parkinson's; helping people with Parkinson's and those around them to improve management of memory and thinking problems.

Conditions

Parkinson's Disease (PD)

Outcome Measures

Primary Outcomes (4)

• GAD-7

  Standardized measure of anxiety

  Change in GAD-7 scores after 8 weeks of intervention

• PHQ-9

  Standardized measure of depression

  Change in PHQ-9 scores after 8 weeks of intervention

• PDQ-39

  Standardized measure of quality of life in Parkinson's disease

  Change in PDQ-39 scores after 8 weeks of intervention

• Brief-COPE

  Standardized measure of coping

  Change in Brief-COPE scores after 8 weeks of intervention

Secondary Outcomes (7)

• Healthcare resource use

  Change in CSRI healthcare use after 8 weeks of intervention

• Acceptability

  Following the 8 week intervention

• Acceptability

  Following the 8 weeks of intervention

• Ease of delivery by non-experts

  Following 8-weeks of intervention

• Ease of delivery by non-experts

  Following 8-weeks of intervention

Study Arms (1)

Group-based psychological therapy

EXPERIMENTAL

Behavioral: Group-based psychological therapy

Interventions

Group-based psychological therapy BEHAVIORAL

Group-based psychological therapy for (1) adjusting to diagnosis; (2) Parkinson's anxiety and/or depression; and (3) Parkinson's-related cognitive decline

Group-based psychological therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Parkinson's AND
• within three years of diagnosis OR
• anxiety/depression, as judged by scores above clinical cut-offs on standardized measures OR
• developing Parkinson's-related cognitive impairment/hallucinations/delusions, but retaining capacity to consent, as judged by their medical consultant.
• Aged 18 years and above
• Sufficiently fluent in English
• Able to give informed consent
• Able to attend Queen Square for the intervention
• Able to complete the self-report questionnaires
• Already participating in psychological therapy or research aimed at improving psychological wellbeing.

Sponsors & Collaborators

• University College, London: lead
• UEA Health Economics Consulting: collaborator

Study Sites (1)

University College London

London, United Kingdom

Location

Study Officials

• Jennifer Foley

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention uses a wait-list control condition. All participants are on a wait list for 8 weeks before the start of the intervention, which lasts for 8 weeks, and are then followed up 8 weeks afterwards.

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 28, 2025
• Study Start: July 5, 2024
• Primary Completion: November 30, 2025
• Study Completion: March 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)