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Clinical Trials/NCT06992869
NCT06992869CompletedNot Applicable

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

University College, London1 site in 1 country138 target enrollmentStarted: July 5, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
138
Locations
1
Primary Endpoint
PHQ-9

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Sequential
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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
  • •Exclusion Criterion:
  • •Already participating in psychological therapy or research aimed at improving psychological wellbeing.

Exclusion Criteria

  • Not provided

Arms & Interventions

Group-based psychological therapy

Experimental

Intervention: Group-based psychological therapy (Behavioral)

Outcomes

Primary Outcomes

PHQ-9

Time Frame: Change in PHQ-9 scores after 8 weeks of intervention

Standardized measure of depression

GAD-7

Time Frame: Change in GAD-7 scores after 8 weeks of intervention

Standardized measure of anxiety

PDQ-39

Time Frame: Change in PDQ-39 scores after 8 weeks of intervention

Standardized measure of quality of life in Parkinson's disease

Brief-COPE

Time Frame: Change in Brief-COPE scores after 8 weeks of intervention

Standardized measure of coping

Secondary Outcomes

  • Acceptability(Following the 8 weeks of intervention)
  • Ease of delivery by non-experts(Following 8-weeks of intervention)
  • Ease of delivery by non-expert(Following 8-weeks of intervention)
  • Acceptability(Following the 8 week intervention)
  • Healthcare resource use(Change in CSRI healthcare use after 8 weeks of intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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