Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-01 @ 7:13 AM
Study NCT ID:
NCT06992869
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-28
First Post:
2025-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mental Health Support for People Affected by Parkinson's
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2025-05-08', 'studyFirstSubmitQcDate': '2025-05-19', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GAD-7', 'timeFrame': 'Change in GAD-7 scores after 8 weeks of intervention', 'description': 'Standardized measure of anxiety'}, {'measure': 'PHQ-9', 'timeFrame': 'Change in PHQ-9 scores after 8 weeks of intervention', 'description': 'Standardized measure of depression'}, {'measure': 'PDQ-39', 'timeFrame': 'Change in PDQ-39 scores after 8 weeks of intervention', 'description': "Standardized measure of quality of life in Parkinson's disease"}, {'measure': 'Brief-COPE', 'timeFrame': 'Change in Brief-COPE scores after 8 weeks of intervention', 'description': 'Standardized measure of coping'}], 'secondaryOutcomes': [{'measure': 'Healthcare resource use', 'timeFrame': 'Change in CSRI healthcare use after 8 weeks of intervention', 'description': 'Use of healthcare resources as measured by Client Service Receipt Inventory (CSRI)'}, {'measure': 'Acceptability', 'timeFrame': 'Following the 8 week intervention', 'description': 'Quantitative indicator of acceptability, as measured by Likert scales on questionnaire'}, {'measure': 'Acceptability', 'timeFrame': 'Following the 8 weeks of intervention', 'description': 'Qualitative indicator of acceptability from thematic analysis of open-ended questions on questionnaires and focus group interviews'}, {'measure': 'Ease of delivery by non-experts', 'timeFrame': 'Following 8-weeks of intervention', 'description': 'Ease of delivery by non-experts, determined by comparing change in GAD-7 by intervention lead (nurse vs psychologist)'}, {'measure': 'Ease of delivery by non-experts', 'timeFrame': 'Following 8-weeks of intervention', 'description': 'Ease of delivery by non-experts, determined by comparing change in PHQ-9 by intervention lead (nurse vs psychologist)'}, {'measure': 'Ease of delivery by non-expert', 'timeFrame': 'Following 8-weeks of intervention', 'description': 'Ease of delivery by non-expert, as determined by comparing chnage in PDQ-39 by intervention lead (nurse vs psychologist)'}, {'measure': 'Ease of delivery by non-expert', 'timeFrame': 'Following 8-weeks of intervention', 'description': 'Ease of delivery by non-expert, as determined by comparing change in Brief-COPE by intervention lead (nurse vs psychologist)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson's Disease (PD)']}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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:\n\n1. Adjusting to diagnosis; empowering people to feel more in control.\n2. Anxiety and/or depression; using cognitive-behavioural therapy techniques to improve mood, with particular focus on Parkinson's-specific concerns.\n3. Advanced Parkinson's; helping people with Parkinson's and those around them to improve management of memory and thinking problems.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "All participants will be recruited from the National Hospital for Neurology and Neurosurgery, Queen Square, London.\n\nInclusion Criteria:\n\n1. Diagnosis of Parkinson's AND\n\n 1. within three years of diagnosis OR\n 2. anxiety/depression, as judged by scores above clinical cut-offs on standardized measures OR\n 3. developing Parkinson's-related cognitive impairment/hallucinations/delusions, but retaining capacity to consent, as judged by their medical consultant.\n2. Aged 18 years and above\n3. Sufficiently fluent in English\n4. Able to give informed consent\n5. Able to attend Queen Square for the intervention\n6. Able to complete the self-report questionnaires\n\nExclusion Criterion:\n\n* Already participating in psychological therapy or research aimed at improving psychological wellbeing."}, 'identificationModule': {'nctId': 'NCT06992869', 'briefTitle': "Mental Health Support for People Affected by Parkinson's", 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': "Matching Mental Health Support to the Needs of People Affected by Parkinson's: Patient and Cost Benefits", 'orgStudyIdInfo': {'id': '157987'}, 'secondaryIdInfos': [{'id': 'H-2202', 'type': 'OTHER_GRANT', 'domain': "Parkinson's UK"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group-based psychological therapy', 'interventionNames': ['Behavioral: Group-based psychological therapy']}], 'interventions': [{'name': 'Group-based psychological therapy', 'type': 'BEHAVIORAL', 'description': "Group-based psychological therapy for (1) adjusting to diagnosis; (2) Parkinson's anxiety and/or depression; and (3) Parkinson's-related cognitive decline", 'armGroupLabels': ['Group-based psychological therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Jennifer Foley', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College, London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We do not have explicit consent for sharing of IPD at present.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'collaborators': [{'name': 'UEA Health Economics Consulting', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}