Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT03525093
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2018-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hypnotherapy to Improve Coping With Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006990', 'term': 'Hypnosis'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'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': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-30', 'studyFirstSubmitDate': '2018-04-23', 'studyFirstSubmitQcDate': '2018-05-14', 'lastUpdatePostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived Stress on Visual Analogue Scale', 'timeFrame': '5 weeks', 'description': 'Visual Analogue Scale of perceived stress in the last week, 0-100 mm (0=no stress; 100 = extreme stress)'}], 'secondaryOutcomes': [{'measure': 'Perceived Stress on Visual Analogue Scale', 'timeFrame': '12 weeks', 'description': 'Visual Analogue Scale of perceived stress in the last week, 0-100 mm (0=no stress; 100 = extreme stress)'}, {'measure': 'Cohens Perceived Stress Scale 10 Items', 'timeFrame': '5 weeks, 12 weeks', 'description': 'Cohen S, Kamarck T, and Mermelstein R, "A global measure of perceived stress," Journal of Health and Social Behavior, vol. 24, no. 4, pp. 385-396, 1983.'}, {'measure': 'Stress reduction on Likert Scale', 'timeFrame': '5 weeks, 12 weeks', 'description': 'Stress rating on a Likert Scale'}, {'measure': 'Allgemeine Depressionsskala (ADS-K)', 'timeFrame': '5 weeks, 12 weeks', 'description': 'Hautzinger M, Bailer M, Hofmeister D, Keller F. (2012). Allgemeine Depressionsskala (ADS) (2. Aufl.). Göttingen: Hogrefe.'}, {'measure': 'General Self Efficacy Scale (Schwarzer)', 'timeFrame': '5 weeks, 12 weeks', 'description': 'Schwarzer R, Jerusalem M. (Hrsg.). Skalen zur Erfassung von Lehrer- und Schülermerkmalen: Dokumentation der psychometrischen Verfahren im Rahmen der Wissenschaftlichen Begleitung des Modellversuchs Selbstwirksame Schulen. Berlin: Freie Universität Berlin, 1999.'}, {'measure': 'SF 36 Quality of Life', 'timeFrame': '5 weeks, 12 weeks', 'description': 'Bullinger M, Kirchberger I: SF-36: Fragebogen zum Gesundheitszustand, Hogrefe, Göttingen, Germany, 1998.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress, Psychological']}, 'referencesModule': {'references': [{'pmid': '38708017', 'type': 'DERIVED', 'citation': 'Siewert J, Teut M, Brinkhaus B, Fisch S, Kummer S. The relevance of outcome expectations in group hypnosis for stress reduction: a secondary analysis of a multicenter randomized controlled trial. Front Psychol. 2024 Apr 19;15:1363037. doi: 10.3389/fpsyg.2024.1363037. eCollection 2024.'}, {'pmid': '33187503', 'type': 'DERIVED', 'citation': 'Fisch S, Trivakovic-Thiel S, Roll S, Keller T, Binting S, Cree M, Brinkhaus B, Teut M. Group hypnosis for stress reduction and improved stress coping: a multicenter randomized controlled trial. BMC Complement Med Ther. 2020 Nov 13;20(1):344. doi: 10.1186/s12906-020-03129-6.'}]}, 'descriptionModule': {'briefSummary': 'This prospective controlled study aims to test a 5 week group hypnosis training as intervention to improve coping with perceived psychological stress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy or health-stable participants between 18 and 65 years with increased perceived stress for at least 3 months\n* Perceived stress in the last week on the visual analog scale\\> 40 mm (VAS 0 - 100 mm)\n* Ability to consent and sign declaration of consent\n\nExclusion Criteria:\n\n* Current or planned participation in a stress management exercise within the next 17 weeks\n* Current use of psychotherapeutic treatment\n* Presence of moderate or severe acute or chronic disease\n* Presence of an acute or chronic mental disorder\n* Participation in a study within the last 2 months prior to enrollment\n* Lack of understanding of the German language'}, 'identificationModule': {'nctId': 'NCT03525093', 'briefTitle': 'Hypnotherapy to Improve Coping With Stress', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'A Hypnotherapeutic Group Training to Improve Coping With Perceived Stress - a Prospective Controlled Interventional Multicenter Trial', 'orgStudyIdInfo': {'id': 'HYPNOSTRESS2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hypnosis + health education', 'description': '5 sessions of group hypnosis, each 90 minutes; plus CDs/MP3 recordings to train at home plus health education booklet on coping with stress', 'interventionNames': ['Behavioral: Hypnosis']}, {'type': 'OTHER', 'label': 'Health education alone', 'description': 'Patients receive a health education booklet to improve coping with stress', 'interventionNames': ['Behavioral: Health education']}], 'interventions': [{'name': 'Hypnosis', 'type': 'BEHAVIORAL', 'description': '5 session of group hypnosis, each 90 minutes, to reduce subjective levels of stress, improve coping with stress. Additional audiotapes of hypnosis sessions as homework.\n\nParticipants receive a health education booklet on improving coping with stress.', 'armGroupLabels': ['Hypnosis + health education']}, {'name': 'Health education', 'type': 'BEHAVIORAL', 'description': 'Participants receive a health education booklet on improving coping with stress.', 'armGroupLabels': ['Health education alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité University Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Benno Brinkhaus', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}