Clinical trial NCT06992869: Mental Health Support for People Affected by Parkinson's
Official title: Matching Mental Health Support to the Needs of People Affected by Parkinson's: Patient and Cost Benefits
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Parkinson&#39;s Disease (PD)
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: UEA Health Economics Consulting
First posted: 2025-05-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: GAD-7
timeFrame: Change in GAD-7 scores after 8 weeks of intervention
measure: PHQ-9
timeFrame: Change in PHQ-9 scores after 8 weeks of intervention
measure: PDQ-39
timeFrame: Change in PDQ-39 scores after 8 weeks of intervention
measure: Brief-COPE
timeFrame: Change in Brief-COPE scores after 8 weeks of intervention
Secondary outcomes:
measure: Healthcare resource use
timeFrame: Change in CSRI healthcare use after 8 weeks of intervention
measure: Acceptability
timeFrame: Following the 8 week intervention
measure: Acceptability
timeFrame: Following the 8 weeks of intervention
measure: Ease of delivery by non-experts
timeFrame: Following 8-weeks of intervention
measure: Ease of delivery by non-experts
timeFrame: Following 8-weeks of intervention
measure: Ease of delivery by non-expert
timeFrame: Following 8-weeks of intervention
measure: Ease of delivery by non-expert
timeFrame: Following 8-weeks of intervention
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
Study officials:
affiliation: University College, London
name: Jennifer Foley
role: PRINCIPAL_INVESTIGATOR
References: