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Completed

NCT Number: NCT06992869

Mental Health Support for People Affected by Parkinson's

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College London

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

All participants will be recruited from the National Hospital for Neurology and Neurosurgery, Queen Square, London.

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.

Treatment and study plan

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

Primary outcomes

  1. GAD-7

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

    Standardized measure of anxiety

  2. PHQ-9

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

    Standardized measure of depression

  3. PDQ-39

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

    Standardized measure of quality of life in Parkinson's disease

  4. Brief-COPE

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

    Standardized measure of coping

Secondary outcomes

  1. Healthcare resource use

    Time frame: Change in CSRI healthcare use after 8 weeks of intervention

    Use of healthcare resources as measured by Client Service Receipt Inventory (CSRI)

  2. Acceptability

    Time frame: Following the 8 week intervention

    Quantitative indicator of acceptability, as measured by Likert scales on questionnaire

  3. Acceptability

    Time frame: Following the 8 weeks of intervention

    Qualitative indicator of acceptability from thematic analysis of open-ended questions on questionnaires and focus group interviews

  4. Ease of delivery by non-experts

    Time frame: Following 8-weeks of intervention

    Ease of delivery by non-experts, determined by comparing change in GAD-7 by intervention lead (nurse vs psychologist)

  5. Ease of delivery by non-experts

    Time frame: Following 8-weeks of intervention

    Ease of delivery by non-experts, determined by comparing change in PHQ-9 by intervention lead (nurse vs psychologist)

  6. Ease of delivery by non-expert

    Time frame: Following 8-weeks of intervention

    Ease of delivery by non-expert, as determined by comparing chnage in PDQ-39 by intervention lead (nurse vs psychologist)

  7. Ease of delivery by non-expert

    Time frame: Following 8-weeks of intervention

    Ease of delivery by non-expert, as determined by comparing change in Brief-COPE by intervention lead (nurse vs psychologist)

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • UEA Health Economics Consulting

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 28, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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