Parkinson's Disease (PD)NCT06992869
Mental Health Support for People Affected by Parkinson's
A study testing Group-based psychological therapy in people with Parkinson's Disease (PD), run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- Group-based psychological therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jul 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Able to give informed consent
- Able to attend Queen Square for the intervention
- Able to complete the self-report questionnaires
Who cannot join
- Already participating in psychological therapy or research aimed at improving psychological wellbeing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Matching Mental Health Support to the Needs of People Affected by Parkinson's: Patient and Cost Benefits
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:
Read more
- Adjusting to diagnosis; empowering people to feel more in control.
- Anxiety and/or depression; using cognitive-behavioural therapy techniques to improve mood, with particular focus on Parkinson's-specific concerns.
- 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.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- Group-based psychological therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based psychological therapyBehavioural
Group-based psychological therapy for (1) adjusting to diagnosis; (2) Parkinson's anxiety and/or depression; and (3) Parkinson's-related cognitive decline
| Study group | Role | What they receive |
|---|---|---|
| Group-based psychological therapy | Experimental | Not described Receives: Behavioral: Group-based psychological therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAD-7
Standardized measure of anxiety
Measured: Change in GAD-7 scores after 8 weeks of intervention
PHQ-9
Standardized measure of depression
Measured: Change in PHQ-9 scores after 8 weeks of intervention
PDQ-39
Standardized measure of quality of life in Parkinson's disease
Measured: Change in PDQ-39 scores after 8 weeks of intervention
Brief-COPE
Standardized measure of coping
Measured: Change in Brief-COPE scores after 8 weeks of intervention
Secondary outcomes (7)
Healthcare resource use
Use of healthcare resources as measured by Client Service Receipt Inventory (CSRI)
Measured: Change in CSRI healthcare use after 8 weeks of intervention
Acceptability
Quantitative indicator of acceptability, as measured by Likert scales on questionnaire
Measured: Following the 8 week intervention
Acceptability
Qualitative indicator of acceptability from thematic analysis of open-ended questions on questionnaires and focus group interviews
Measured: Following the 8 weeks of intervention
Ease of delivery by non-experts
Ease of delivery by non-experts, determined by comparing change in GAD-7 by intervention lead (nurse vs psychologist)
Measured: Following 8-weeks of intervention
Ease of delivery by non-experts
Ease of delivery by non-experts, determined by comparing change in PHQ-9 by intervention lead (nurse vs psychologist)
Measured: Following 8-weeks of intervention
Ease of delivery by non-expert
Ease of delivery by non-expert, as determined by comparing chnage in PDQ-39 by intervention lead (nurse vs psychologist)
Measured: Following 8-weeks of intervention
Ease of delivery by non-expert
Ease of delivery by non-expert, as determined by comparing change in Brief-COPE by intervention lead (nurse vs psychologist)
Measured: Following 8-weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start5 Jul 2024
- Primary completion30 Nov 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- UEA Health Economics Consulting
- Responsible party
- Sponsor
- Investigators
- Jennifer Foley, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992869
- Sponsor's protocol ID
- 157987
- Other IDs
- H-2202
- Status last verified
- Apr 2026
- First submitted
- 8 May 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not have explicit consent for sharing of IPD at present.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Matching Mental Health Support to the Needs of People Affected by Parkinson's: Patient and Cost Benefits
- ClinicalTrials.gov ID
- NCT06992869
- Acronym / sponsor ID
- 157987
- Conditions
- Parkinson's Disease (PD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- UEA Health Economics Consulting
- Study start
- 5 Jul 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Adjusting to diagnosis; empowering people to feel more in control.
- Anxiety and/or depression; using cognitive-behavioural therapy techniques to improve mood, with particular focus on Parkinson's-specific concerns.
- 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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group-based psychological therapy | Experimental | Behavioral: Group-based psychological therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of Parkinson's AND
- Aged 18 years and above
- Sufficiently fluent in English
- Able to give informed consent
- Able to attend Queen Square for the intervention
Key exclusion criteria (1 listed)
- Already participating in psychological therapy or research aimed at improving psychological wellbeing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group-based psychological therapyGroup-based psychological therapy for (1) adjusting to diagnosis; (2) Parkinson's anxiety and/or depression; and (3) Parkinson's-related cognitive decline | Behavioural | Group-based psychological therapy |
Primary outcome
GAD-7
Time frame: Change in GAD-7 scores after 8 weeks of intervention
Standardized measure of anxiety
PHQ-9
Time frame: Change in PHQ-9 scores after 8 weeks of intervention
Standardized measure of depression
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
7 secondary outcomes
Healthcare resource use
Time frame: Change in CSRI healthcare use after 8 weeks of intervention
Acceptability
Time frame: Following the 8 week intervention
Acceptability
Time frame: Following the 8 weeks of intervention
Ease of delivery by non-experts
Time frame: Following 8-weeks of intervention
Ease of delivery by non-experts
Time frame: Following 8-weeks of intervention
Ease of delivery by non-expert
Time frame: Following 8-weeks of intervention
Ease of delivery by non-expert
Time frame: Following 8-weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. We do not have explicit consent for sharing of IPD at present.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Foley principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based psychological therapy in people with Parkinson's Disease (PD), run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GAD-7 (time frame: Change in GAD-7 scores after 8 weeks of intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.