Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT03535493
Status:
TERMINATED
Last Update Posted:
2018-08-29
First Post:
2018-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of ACT and Float REST on Burnout Syndrome.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077062', 'term': 'Burnout, Psychological'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'whyStopped': 'Ethics Committee concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-27', 'studyFirstSubmitDate': '2018-05-13', 'studyFirstSubmitQcDate': '2018-05-22', 'lastUpdatePostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing Change in Maslach Burnout Inventory - Human Services Survey (MBI-HSS)', 'timeFrame': 'Metric will be used as screening prior to study intervention; continuous measurement at week 2, week 4, week 6, week 8 and at one month follow-up.', 'description': 'A 22 item scale that measures depersonalization, emotional exhaustion, and personal accomplishment. It is designed for professionals in human services in an array of occupations including nurses, physicians, health aides, social workers, health counselors, therapists, police, correctional officers, clergy, and other fields focused on helping people live better lives by offering guidance, preventing harm, and ameliorating cognitive, emotional, or physical problems.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Burnout Syndrome']}, 'descriptionModule': {'briefSummary': 'In 1982, Steven Hayes, a clinical psychologist, developed Acceptance and Commitment Therapy (ACT), a unique empirically based psychological intervention that uses acceptance and mindfulness strategies, together with commitment and behavior change strategies, to increase psychological flexibility. In 1954, John Lilly, a cognitive neuroscientist, developed the sensory deprivation tank (known today as Floatation Restricted Environmental Stimulation Therapy - Float REST), to access a wide range of healing, higher brain functions, and meditation through an unparalleled deep relaxation state. In this study, the investigators aim to examine whether participants in the ACT + Float REST condition will have larger decreases of the burnout phenomenon than those who receive either only ACT or Float REST.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True}, 'identificationModule': {'nctId': 'NCT03535493', 'briefTitle': 'The Effect of ACT and Float REST on Burnout Syndrome.', 'organization': {'class': 'OTHER', 'fullName': 'International Behavioral Research Institute'}, 'officialTitle': 'The Effect of Acceptance and Commitment Therapy (ACT) and Float REST (Restricted Environmental Stimulation Therapy) on Burnout Syndrome.', 'orgStudyIdInfo': {'id': 'IBRI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acceptance and Commitment Therapy (ACT)', 'interventionNames': ['Behavioral: Acceptance and Commitment Therapy (ACT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Float REST', 'interventionNames': ['Behavioral: Float REST']}, {'type': 'EXPERIMENTAL', 'label': 'ACT + Float REST', 'interventionNames': ['Behavioral: ACT + Float REST']}], 'interventions': [{'name': 'Acceptance and Commitment Therapy (ACT)', 'type': 'BEHAVIORAL', 'description': 'An ACT session entails a mindfulness-based training to foster and nurture effective behavioral and emotional responding to distress.', 'armGroupLabels': ['Acceptance and Commitment Therapy (ACT)']}, {'name': 'Float REST', 'type': 'BEHAVIORAL', 'otherNames': ['Float Therapy, Isolation Tank, Sensory Deprivation Tank'], 'description': 'A float session entails laying supine in a light-proof, sound-proof tank consisting of a shallow pool of water (approximately 10 inches set to approximately 94.5 degrees to match skin temperature) with a high concentration of Epsom salt (approximately 1200 pounds) for 60 minutes.', 'armGroupLabels': ['Float REST']}, {'name': 'ACT + Float REST', 'type': 'BEHAVIORAL', 'description': 'The combined intervention will combine ACT and Float REST. An ACT session entails a mindfulness-based training to foster and nurture effective behavioral and emotional responding to distress. A float session entails laying supine in a light-proof, sound-proof tank consisting of a shallow pool of water (approximately 10 inches set to approximately 94.5 degrees to match skin temperature) with a high concentration of Epsom salt (approximately 1200 pounds) for 60 minutes.', 'armGroupLabels': ['ACT + Float REST']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60174', 'city': 'Saint Charles', 'state': 'Illinois', 'country': 'United States', 'facility': 'International Behavioral Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amrinder Babbra', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amrinder Babbra', 'investigatorAffiliation': 'International Behavioral Research Institute'}}}}