Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-27 @ 10:38 PM
Study NCT ID:
NCT01168661
Status:
COMPLETED
Last Update Posted:
2010-07-23
First Post:
2010-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yoga, Mindfulness and Cognitive Psychotherapy as Treatment for Stress and Burnout
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D002055', 'term': 'Burnout, Professional'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-22', 'studyFirstSubmitDate': '2010-07-22', 'studyFirstSubmitQcDate': '2010-07-22', 'lastUpdatePostDateStruct': {'date': '2010-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduced stress measured by qualitative questionnaires', 'timeFrame': '5 months after start of treatment', 'description': 'Level of stress will be measured by qualitiative questionnaries, including the Swedish Health-Related Quality of Life Survey (SWEQUAL).'}], 'secondaryOutcomes': [{'measure': 'Reduced cortisol secretion', 'timeFrame': '5 months after start of treatment', 'description': 'We will measure cortisol level in a 24-hour sample of urine.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stress', 'Burnout', 'Anxiety', 'Depression'], 'conditions': ['Stress, Psychological', 'Burnout, Professional', 'Anxiety', 'Depression']}, 'referencesModule': {'references': [{'pmid': '29510704', 'type': 'DERIVED', 'citation': 'Grensman A, Acharya BD, Wandell P, Nilsson GH, Falkenberg T, Sundin O, Werner S. Effect of traditional yoga, mindfulness-based cognitive therapy, and cognitive behavioral therapy, on health related quality of life: a randomized controlled trial on patients on sick leave because of burnout. BMC Complement Altern Med. 2018 Mar 6;18(1):80. doi: 10.1186/s12906-018-2141-9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate if treatment with yoga or mindfulness has a more profound and longstanding effect on stress and burnout than treatment with cognitive psychotherapy alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* On sick leave at least 50% at the beginning of the study.\n* Sick leave for a maximum of 1 year if on full-time sick leave at the beginning of the study or for a maximum of 3 years if on part-time sick leave at the beginning of the study.\n* Speak Swedish well enough to participate in the study interventions.\n* Body mass index (BMI) of between 18 and 30.\n* Meet the diagnostic criteria for burnout syndrome from the Swedish National Board of Health and Welfare.\n\nExclusion Criteria:\n\n* Medication, including all medication or topical skin preparations with cortisone in any form. Exceptions: Antidepressants, contraceptives, hormone replacement therapy for hypothyroidism if hormone levels were within the normal range, and hormone replacement therapy to treat menopausal symptoms. To receive an exception for medication, a participant had to take the same medication at the same dose at both blood tests.'}, 'identificationModule': {'nctId': 'NCT01168661', 'briefTitle': 'Yoga, Mindfulness and Cognitive Psychotherapy as Treatment for Stress and Burnout', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Yoga, Mindfulness and Cognitive Psychotherapy as Treatment for Stress and Burnout', 'orgStudyIdInfo': {'id': 'Pickup 2003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Participants in this arm will be recruited from the group who applied to participate in the study and fulfilled the inclusion criteria but for various reasons (such as time constraints) could not participate.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive psychotherapy arm', 'description': 'In this arm, participants will attend a group meeting to practice cognitive psychotherapy once a week. They will also practice on their own \\>= 4 times a week.', 'interventionNames': ['Behavioral: Cognitive psychotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mindfulness based cog psychotherapy arm', 'description': 'In this arm, participants will attend a group meeting to practice mindfulness based cognitive psychotherapy once a week. They will also practice on their own \\>= 4 times a week.', 'interventionNames': ['Behavioral: Mindfulness based cog psychotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Yoga treatment group', 'description': 'Persons in this arm will practice yoga \\>= 5 time each week (2 times in a supervised group and the other times on their own).', 'interventionNames': ['Behavioral: Yoga']}], 'interventions': [{'name': 'Yoga', 'type': 'BEHAVIORAL', 'description': 'Participants in this intervention arm will practice yoga (physical postures, breathing exercises, and meditation) \\>= 5 times a week (twice in a supervised group and the rest on their own). Additionally, participants in this arm will practice various practical skills, such as how to plan a satisfactory day using their own definition of a satisfactory day. They will follow this schedule for 20 weeks.', 'armGroupLabels': ['Yoga treatment group']}, {'name': 'Mindfulness based cog psychotherapy', 'type': 'BEHAVIORAL', 'description': 'Participants in this arm will attend a weekly group meeting to practice mindfulness based cognitive psychotherapy. They will also practice \\>= 4 time a week on their own. Additionally, participants in this arm will practice various practical skills, such as how to plan a satisfactory day using their own definition of a satisfactory day. Participants will follow this schedule for 20 weeks.', 'armGroupLabels': ['Mindfulness based cog psychotherapy arm']}, {'name': 'Cognitive psychotherapy', 'type': 'BEHAVIORAL', 'description': 'Participants in this arm will attend a weekly group meeting to practice cognitive psychotherapy. They will also practice \\>= 4 time a week on their own. Additionally, participants in this arm will practice various practical skills, such as how to plan a satisfactory day using their own definition of a satisfactory day. Participants will follow this schedule for 20 weeks.', 'armGroupLabels': ['Cognitive psychotherapy arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14183', 'city': 'Stockholm', 'state': 'Huddinge', 'country': 'Sweden', 'facility': 'Karolinska Institutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Astrid M Grensman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Bikash Dev Acharya, MSc Psyc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Stockholm', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Astrid Grensman, MD', 'oldOrganization': 'Karolinska Institutet, Center for Family and Community Medicine'}}}}