Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 11:38 PM
Study NCT ID:
NCT05377294
Status:
COMPLETED
Last Update Posted:
2023-05-15
First Post:
2022-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acceptability and Feasibility of MOL in Acute Inpatient Units
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-12', 'studyFirstSubmitDate': '2022-05-08', 'studyFirstSubmitQcDate': '2022-05-11', 'lastUpdatePostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Psychological Outcomes Profile (descriptive)', 'timeFrame': 'End of therapy research meeting', 'description': 'Outcome measure assessing idiosyncratic problems and distress'}, {'measure': 'Clinical Outcomes in Routine Evaluation-OM (descriptive)', 'timeFrame': 'End of therapy research meeting', 'description': 'Outcome measure assessing idiosyncratic problems and distress'}, {'measure': 'Reorganisation of Conflict Scale (descriptive)', 'timeFrame': 'End of therapy research meeting', 'description': 'Outcome measure assessing goal conflict reorganisation (a key mechanism of change in MOL)'}, {'measure': 'Community Assessment of Psychic Experiences (if experiencing psychosis at point of consent)', 'timeFrame': 'End of therapy research meeting', 'description': 'Outcome measure assessing experiences of psychosis'}, {'measure': 'Linehan Reasons for Living Inventory (if experiencing suicidality at point of consent)', 'timeFrame': 'End of therapy research meeting', 'description': 'Outcome measure assessing experiences of suicidality'}], 'primaryOutcomes': [{'measure': 'Proportion of approved patients recruited', 'timeFrame': 'Study consent meeting, approx. 1 week after initial meeting', 'description': 'We will deem the study feasible if at least 72% of approached people consent to participate'}, {'measure': 'Proportion of recruited patients retained', 'timeFrame': 'End of therapy interview', 'description': 'We will deem the study feasible if least 62% of recruited participants are retained (i.e. receive at least one therapy session and complete the end of therapy measures and interview)'}, {'measure': 'Number of participants who receiving the intervention', 'timeFrame': 'End of first therapy session, approx. 2 weeks after initial meeting', 'description': 'We will deem the study feasible if 10 participants receive at least one therapy session'}, {'measure': 'Acceptability (qualitative)', 'timeFrame': 'End of therapy interview', 'description': 'Qualitative interview with participant at end of therapy analysed using Thematic Analysis'}, {'measure': 'Results of Novel Client Measure (descriptive)', 'timeFrame': 'End of therapy research meeting', 'description': 'Qualitative self-reported perception of what was helpful about the therapeutic environment'}, {'measure': 'Results of Outcome Rating Scale (descriptive)', 'timeFrame': 'End of therapy research meeting', 'description': 'Qualitative self-report measure assessing areas of life functioning known to change as a result of therapeutic intervention'}, {'measure': 'Feasibility of adaptions required', 'timeFrame': 'Final follow up meeting with final participant, 3 months after consent', 'description': 'Qualitative record of adaptions required for use of MOL in an acute inpatient setting'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychosis', 'Suicidal']}, 'descriptionModule': {'briefSummary': 'The current study aims to test the acceptability and feasibility of a psychological therapy called Method of Levels (MOL) as an intervention for people in acute psychiatric inpatient units who are experiencing psychosis and/or suicidality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults over the age of 18 years\n* Current service user in an acute inpatient ward in the Greater Manchester area\n* Capacity to provide informed consent for participating in research\n* Good command of English language\n* WS1: Experiencing psychosis (this will be screened for using a clinical cut-off score on the CAPE (Mossaheb et al., 2012))\n* WS2: Experiencing suicidality (this will be screened for using a cynical cut-off score on the Suicidal Behaviours Questionnaire - revised (SBQ-R) (Osman et al., 2001))\n\nExclusion Criteria:\n\n* Problems of an organic nature or a learning disability that might affect cognitive functioning'}, 'identificationModule': {'nctId': 'NCT05377294', 'briefTitle': 'Acceptability and Feasibility of MOL in Acute Inpatient Units', 'organization': {'class': 'OTHER', 'fullName': 'University of Manchester'}, 'officialTitle': 'Is Method of Levels (MOL) Therapy an Acceptable and Feasible Psychological Intervention for People in Acute Mental Health Inpatient Services: A Case Series.', 'orgStudyIdInfo': {'id': '305321'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MOL therapy', 'description': 'Participants with Psychosis and/or Suicidality receiving MOL therapy', 'interventionNames': ['Other: Method of Levels therapy']}], 'interventions': [{'name': 'Method of Levels therapy', 'type': 'OTHER', 'description': 'MOL therapy aims to help people develop awareness of their personal goals so they can identify incompatibilities and find potential solutions. In MOL, the therapist uses a specific style to help people focus attention on the problem at hand, long enough to consider the issues from different perspectives, including reflection on the associated emotions. This process is usually very experiential and requires the client to be actively engaged in controlling the focus of the session and decision making.', 'armGroupLabels': ['MOL therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'GMMH Park House', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'GMMH: Laureate House', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Sara Tai, DClinPsy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manchester'}, {'name': 'Yvonne Awenat, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manchester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manchester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ms Lydia Carr, Trainee Clinical Psychologist', 'investigatorFullName': 'Lydia Carr', 'investigatorAffiliation': 'University of Manchester'}}}}