Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-28 @ 4:48 PM
Study NCT ID:
NCT01348750
Status:
COMPLETED
Last Update Posted:
2011-05-05
First Post:
2011-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healing Touch & Guided Imagery for Posttraumatic Stress Disorder Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014110', 'term': 'Touch'}, {'id': 'D019018', 'term': 'Imagery, Psychotherapy'}], 'ancestors': [{'id': 'D012677', 'term': 'Sensation'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'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': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-04', 'studyFirstSubmitDate': '2011-05-03', 'studyFirstSubmitQcDate': '2011-05-04', 'lastUpdatePostDateStruct': {'date': '2011-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '17-item PTSD Checklist (Military)is used to determine the effect of the intervention', 'timeFrame': 'After 6 treatments of healing touch and guided imagery'}], 'secondaryOutcomes': [{'measure': 'Depression (Beck Depression Inventory)', 'timeFrame': 'After 6 treatments of healing touch and guided imagery'}, {'measure': 'Quality of Life (SF36)', 'timeFrame': 'After 6 treatments of healing touch and guided imagery'}, {'measure': 'Hostility (Cook-Medley Hostility Inventory)', 'timeFrame': 'After 6 treatments of healing touch and guided'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PTSD', 'Healing Touch', 'Guided Imagery', 'Military', 'Complementary Medicine'], 'conditions': ['Post-Traumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled 2 year trial at Camp Pendleton, CA to determine whether a complementary medicine intervention (Healing Touch with Guided Imagery, HT+GI) reduces Posttraumatic Stress Disorder (PTSD) symptoms as compared to treatment as usual (TAU) in returning combat-exposed active duty military with significant PTSD symptoms. Secondary aims will evaluate the effect of HT and GI on measures of depression, hostility, and general health status in this population.', 'detailedDescription': 'The study enrolled 123 active duty subjects from the Marine Corps Base Camp Pendleton in Southern California with at least one or more symptoms of PTSD .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female or male subjects 18 years or older\n2. Post-deployment from a combat zone\n3. Identified by post-deployment health re-assessment to have PTSD symptoms\n4. Referred by Camp Pendleton\n5. Subjects who are willing to sign a consent\n6. Subjects who are willing to participate for the length of the study\n\nExclusions:\n\n1. Female subjects who are now pregnant or nursing\n2. Subjects who are receiving healing touch or using guided imagery from other sources\n3. Subjects who have any major health condition that may interfere with participating in this study'}, 'identificationModule': {'nctId': 'NCT01348750', 'briefTitle': 'Healing Touch & Guided Imagery for Posttraumatic Stress Disorder Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Scripps Center for Integrative Medicine'}, 'officialTitle': 'Healing Touch and Guided Imagery Intervention in Post-deployment Military Personnel With Posttraumatic Stress Disorder Symptoms', 'orgStudyIdInfo': {'id': 'PTSD_HSC07_4684'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group A', 'description': 'This group receives 6 Healing Touch \\& Guided Imagery treatments in addition to standard medical care.', 'interventionNames': ['Other: Healing Touch & Guided Imagery']}, {'type': 'NO_INTERVENTION', 'label': 'Group B', 'description': 'This group receives standard medical care but NO Healing Touch and Guided Imagery.'}], 'interventions': [{'name': 'Healing Touch & Guided Imagery', 'type': 'OTHER', 'description': 'Healing Touch (HT) is an energy based approach to health and healing. It uses light touch to influence the energy field that surrounds the body, and the energy centers which control the flow of energy to the physical body.\n\nHT complements traditional health care and is used together with other approaches to health and healing.\n\nGuided Imagery (GI) is a form of focused relaxation used to create harmony between the mind and body. Positive mental imagery can promote relaxation, reduce stress and improve mood as well as alter heart rate, blood pressure and breathing.', 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Center for Integrative Medicine', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Erminia M Guarneri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scripps Center for Integrative Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scripps Center for Integrative Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Marine Corps Base Camp Pendleton', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Erminia M. Guarneri, MD, Medical Director', 'oldOrganization': 'Scripps Center for Integrative Medicine'}}}}