Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-05-01 @ 1:44 PM
Study NCT ID:
NCT02458105
Status:
WITHDRAWN
Last Update Posted:
2018-05-11
First Post:
2015-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptance & Commitment Therapy for Psychotic Inpatients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064869', 'term': 'Acceptance and Commitment Therapy'}, {'id': 'D009483', 'term': 'Neuropsychological Tests'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D011581', 'term': 'Psychological Tests'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Required resources not available at the moment.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-04', 'studyFirstSubmitDate': '2015-05-27', 'studyFirstSubmitQcDate': '2015-05-28', 'lastUpdatePostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rehospitalization', 'timeFrame': '12 months', 'description': 'Whether or not, and if so for how many days, a patient has ben readmitted to inpatient care during the follow-up period.'}], 'secondaryOutcomes': [{'measure': "Bull's Eye Values Inventory", 'timeFrame': '12 months', 'description': 'Quality of life instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.'}, {'measure': 'EQ-5D', 'timeFrame': '12 months', 'description': 'Health related quality of life instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.'}, {'measure': 'Clinical Global Impression Scale', 'timeFrame': '12 months', 'description': 'Symptom severity instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.'}, {'measure': 'Acceptance & Action Questionnaire', 'timeFrame': '12 months', 'description': 'Psychological flexibility instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.'}, {'measure': 'Psychotic Symptom Rating Scales', 'timeFrame': '12 months', 'description': 'Symptom severity instrument to be administered before treatment, after treatment, and at 3, 6 and 12 month follow-up.'}, {'measure': 'Checklist of Unit Behaviors', 'timeFrame': 'During inpatient care.', 'description': 'Measure for degree of activity on the ward.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acceptance and commitment therapy', 'Cognitive behavior therapy'], 'conditions': ['Acute Psychosis']}, 'descriptionModule': {'briefSummary': 'The overarching aim of the research project is to investigate whether Acceptance \\& Commitment Therapy (ACT) is an efficacious psychotherapeutic method of treatment for inpatients suffering from acute psychosis.\n\nThe method will be applied in two ways. Firstly, as an individual treatment for patients. Secondly, as an integrated part of the daily work on an inpatient ward, administered by nurses and assistant nurses trained in the method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to a specified psychiatric inpatient ward during the time-period of the study; psychotic spectrum diagnosis as specified in patient charts; assessed by contact person on the ward as having delusions or hallucinations.\n\nExclusion Criteria:\n\n* Cognitive difficulties to an extent where informed consent cannot be given.'}, 'identificationModule': {'nctId': 'NCT02458105', 'briefTitle': 'Acceptance & Commitment Therapy for Psychotic Inpatients', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Acceptance & Commitment Therapy for Psychotic Inpatients', 'orgStudyIdInfo': {'id': '2014/541'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acceptance & Commitment Therapy', 'description': 'A variant of cognitive behavior therapy focused on acceptance and valued living in the presence of distressing symptoms.', 'interventionNames': ['Behavioral: Acceptance & Commitment Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Attention', 'description': 'Supportive conversation at a frequency and length corresponding to the experimental condition.', 'interventionNames': ['Behavioral: Attention']}], 'interventions': [{'name': 'Acceptance & Commitment Therapy', 'type': 'BEHAVIORAL', 'description': 'A variant of cognitive behavior therapy focused on acceptance and valued living in the presence of distressing symptoms.', 'armGroupLabels': ['Acceptance & Commitment Therapy']}, {'name': 'Attention', 'type': 'BEHAVIORAL', 'description': 'Supportive conversation at a frequency and length corresponding to the experimental condition.', 'armGroupLabels': ['Attention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Västerås', 'country': 'Sweden', 'facility': 'Västmanland Hospital, Västerås, Västmanland County Council', 'geoPoint': {'lat': 59.61617, 'lon': 16.55276}}], 'overallOfficials': [{'name': 'Tobias Lundgren, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Stockholm University; Karolinska Institutet, department of Clinical Neuroscience & Centre for Psychiatry Research and Education, Stockholm County Council'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stockholm University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}