Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT04630912
Status:
COMPLETED
Last Update Posted:
2022-08-19
First Post:
2020-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ACT for People With Dementia Experiencing Psychological Distress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064869', 'term': 'Acceptance and Commitment Therapy'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Hermeneutic single case efficacy design (HSCED) series'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-16', 'studyFirstSubmitDate': '2020-11-02', 'studyFirstSubmitQcDate': '2020-11-10', 'lastUpdatePostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in anxiety', 'timeFrame': 'Through study completion, up to 24 weeks', 'description': 'Generalised anxiety disorder questionnaire (GAD-7), scored 0-21, where higher scores indicate a greater severity of anxiety.'}, {'measure': 'Change in depression', 'timeFrame': 'Through study completion, up to 24 weeks', 'description': 'Patient health questionnaire (PHQ-9), scored 0-27, where higher scores indicate a greater severity of depression.'}], 'secondaryOutcomes': [{'measure': 'Change in psychological flexibility', 'timeFrame': 'Through study completion, up to 24 weeks', 'description': 'Comprehensive assessment of Acceptance \\& Commitment Therapy (CompACT-SF), scored 0-48, where higher scores indicate increased psychological flexibility.'}, {'measure': 'Change in wellbeing', 'timeFrame': 'Through study completion, up to 24 weeks', 'description': 'Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWS), scored 7-35, where higher scores indicate higher mental wellbeing.'}, {'measure': 'Change in client problems', 'timeFrame': 'Through study completion, up to 24 weeks', 'description': 'Personal questionnaire (PQ), where higher scores indicate greater severity of problems.'}, {'measure': 'Change in therapeutic alliance', 'timeFrame': 'Through study completion, up to 12 weeks', 'description': 'Session rating scale (SRS), does not involve numerical values but asks clients to mark on a line nearest to the description that best fits their experience (marks further towards the right indicate better therapeutic alliance).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dementia', 'Psychological distress', 'Psychological therapy', 'ACT', 'Acceptability', 'HSCED'], 'conditions': ['Acceptance and Commitment Therapy', 'Dementia']}, 'descriptionModule': {'briefSummary': "Introduction: People with dementia have a high prevalence of psychological distress but are under-served with evidence-based psychological interventions. To promote choice and improve clinical outcomes, there is a necessity to test different psychological intervention options for this population. Purpose: To investigate the effectiveness and acceptability of Acceptance and Commitment Therapy (ACT) for people with dementia, considering carer-supported, remote delivery and necessary therapy adaptations. Methods: A hermeneutic single case efficacy design (HSCED) series was used to analyse therapy process and change for three clients with dementia and psychological distress. Quantitative and qualitative data was collated ('rich case records') and analysed by three independent psychotherapy experts ('judges') who determined the outcome for each client. Results: Over the course of therapy, it was concluded that one client with dementia made positive changes, specifically reliable reductions in psychological distress, which were largely attributable to Acceptance and Commitment Therapy (ACT). Two clients remained unchanged. Discussion/Conclusion: Where change was achieved, the ACT-specific processes of values, committed action and acceptance, in combination with non-specific therapy factors including a strong client-carer relationship, existing client interests and individualised therapy adaptations, were facilitative of change. Hence, ACT may be feasible and effective by helping carers to better meet the needs of their loved ones with dementia. Future research to optimise ACT delivery in this population may be beneficial. Furthermore, the assessment of carer factors (e.g., their psychological flexibility, the client-carer relationship) may strengthen the evidence-base for systemic ACT-use."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria for people with dementia\n\nParticipants were included in the study if they had:\n\n* A clinical diagnosis of dementia (any type)\n* A clinically significant level of psychological distress (a score of ≥8 on the GAD-7 and ≥10 on the PHQ-9).\n* Ability to give informed consent\n\nInclusion criteria for caregiver of person with dementia\n\nParticipants were included in the study if they:\n\n* Cared for someone with a clinical diagnosis of dementia (any type)\n* Were paid or unpaid and regularly supported them with activities of daily living\n* Aged 18+ (no maximum age limit)\n* Able to give informed consent\n\nExclusion Criteria:\n\nExclusion criteria for people with dementia\n\nParticipants were excluded if they:\n\n* Were already receiving psychotherapy\n* Had insufficient English or language abilities to engage in therapy\n* Were unable to consent to and/or engage in therapy\n\nExclusion criteria for caregiver of person with dementia\n\nParticipants were excluded if they:\n\n* Had insufficient English or language abilities to support the person with dementia or engage in study/Change Interviews\n* Were unable to consent to and/or engage in study'}, 'identificationModule': {'nctId': 'NCT04630912', 'briefTitle': 'ACT for People With Dementia Experiencing Psychological Distress', 'organization': {'class': 'OTHER', 'fullName': 'University of Nottingham'}, 'officialTitle': 'Acceptance and Commitment Therapy (ACT) for People With Dementia Experiencing Psychological Distress: a Hermeneutic Single Case Efficacy Design (HSCED) Series', 'orgStudyIdInfo': {'id': '20064'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acceptance and Commitment Therapy', 'description': '12 weekly, 90 minute ACT sessions with person with dementia (with a review at week 6)', 'interventionNames': ['Other: Acceptance and Commitment Therapy']}], 'interventions': [{'name': 'Acceptance and Commitment Therapy', 'type': 'OTHER', 'description': "There is no specific protocol for ACT with dementia, therefore a published ACT protocol, 'Better Living with Illness' (Brassington et al., 2016), will be used flexibly to guide the intervention.", 'armGroupLabels': ['Acceptance and Commitment Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Newark', 'state': 'Nottinghamshire', 'country': 'United Kingdom', 'facility': 'Community Mental Health Team for Older People', 'geoPoint': {'lat': 52.59519, 'lon': -0.21222}}], 'overallOfficials': [{'name': 'Danielle De Boos, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Nottingham'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'July 2022', 'ipdSharing': 'YES', 'description': "The study data was written up as part of the student Doctoral Thesis and will be submitted in partial fulfilment of the requirements for the Trent Doctorate in Clinical Psychology (DClinPsy) in February 2022.\n\nParticipants chose a pseudonym for themselves to be used in publications (e.g. electronic documents, written notes and transcripts) to prevent identification and references to personal information (e.g. other people's names, locations) were altered."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nottingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nottinghamshire Healthcare NHS Trust', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}