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Mental Health Support for People Affected by Parkinson's

Matching Mental Health Support to the Needs of People Affected by Parkinson's: Patient and Cost Benefits

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06992869
Enrollment
138
Registered
2025-05-28
Start date
2024-07-05
Completion date
2026-03-31
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease (PD)

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. Adjusting to diagnosis; empowering people to feel more in control. 2. Anxiety and/or depression; using cognitive-behavioural therapy techniques to improve mood, with particular focus on Parkinson's-specific concerns. 3. Advanced Parkinson's; helping people with Parkinson's and those around them to improve management of memory and thinking problems. The research team will design companion booklets for participants, summarizing each session. The treatment will be piloted for one year. If the interventions prove beneficial to participants and are cost-effective, the resources will be made immediately available to healthcare staff across the UK to improve access to specialist psychological services.

Interventions

BEHAVIORALGroup-based psychological therapy

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

Sponsors

University College, London
Lead SponsorOTHER
UEA Health Economics Consulting
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All participants will be recruited from the National Hospital for Neurology and Neurosurgery, Queen Square, London. Inclusion Criteria: 1. Diagnosis of Parkinson's AND 1. within three years of diagnosis OR 2. anxiety/depression, as judged by scores above clinical cut-offs on standardized measures OR 3. developing Parkinson's-related cognitive impairment/hallucinations/delusions, but retaining capacity to consent, as judged by their medical consultant. 2. Aged 18 years and above 3. Sufficiently fluent in English 4. Able to give informed consent 5. Able to attend Queen Square for the intervention 6. Able to complete the self-report questionnaires Exclusion Criterion: * Already participating in psychological therapy or research aimed at improving psychological wellbeing.

Design outcomes

Primary

MeasureTime frameDescription
GAD-7Change in GAD-7 scores after 8 weeks of interventionStandardized measure of anxiety
PHQ-9Change in PHQ-9 scores after 8 weeks of interventionStandardized measure of depression
PDQ-39Change in PDQ-39 scores after 8 weeks of interventionStandardized measure of quality of life in Parkinson's disease
Brief-COPEChange in Brief-COPE scores after 8 weeks of interventionStandardized measure of coping

Secondary

MeasureTime frameDescription
Healthcare resource useChange in CSRI healthcare use after 8 weeks of interventionUse of healthcare resources as measured by Client Service Receipt Inventory (CSRI)
AcceptabilityFollowing the 8 week interventionQuantitative indicator of acceptability, as measured by Likert scales on questionnaire
Ease of delivery by non-expertsFollowing 8-weeks of interventionEase of delivery by non-experts, determined by comparing change in GAD-7 by intervention lead (nurse vs psychologist)
Ease of delivery by non-expertFollowing 8-weeks of interventionEase of delivery by non-expert, as determined by comparing chnage in PDQ-39 by intervention lead (nurse vs psychologist)

Countries

United Kingdom

Contacts

PRINCIPAL_INVESTIGATORJennifer Foley

University College, London

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026