Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-28 @ 7:59 PM
Study NCT ID:
NCT05422768
Status:
UNKNOWN
Last Update Posted:
2023-05-12
First Post:
2022-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PTSD Clinical Team Research Clinic (PCT Research Clinic)
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-05-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2022-02-16', 'studyFirstSubmitQcDate': '2022-06-14', 'lastUpdatePostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in PCL Measures Pre to Post-Intervention and by Intervention Type', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'The Posttraumatic Checklist-5 (PCL) was used to assess self-reported symptoms of PTSD using items consistent with the Diagnostic and Statistical Manual - Fifth Edition. PCL-5 scores can range from 0 to 80 with higher score indicating more PTSD symptoms.'}, {'measure': 'Change in PHQ Measures Pre to Post-Intervention and by Intervention Type', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'The Patient Health Questionnaire (PHQ) was used to assess symptoms of major depression. PHQ scores range from 0 to 27 with higher scores indicating greater depression symptoms.'}, {'measure': 'Change in PTCI Measures Pre to Post-Intervention and by Intervention Type', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'The Posttraumatic Cognitions Inventory (PTCI) was used to assess trauma-related thoughts and beliefs. PTCI can range from 33-252 with higher scores indicating more distress.'}, {'measure': 'Mean and Standard Deviation of Demographic information by Intervention Type', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'The demographic information analyzed includes age, sex, race, ethnicity, religion, service era, service connection, service connection percentage, diagnoses, Emergency Department (ED) visits, Inpatient Psychiatric Unit (IPU) visits, Substance Abuse Residential Rehabilitation Treatment Program (SARRTP) visits.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PTSD'], 'conditions': ['PTSD']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'U.S. Congress. House Report 114-102: National Defense Authorization Act for Fiscal Year 2016; 2015. https://www.congress.gov/congressional-report/114th-congress/house-report/102/1'}, {'pmid': '21757481', 'type': 'RESULT', 'citation': 'Bachi K, Terkel J, Teichman M. Equine-facilitated psychotherapy for at-risk adolescents: the influence on self-image, self-control and trust. Clin Child Psychol Psychiatry. 2012 Apr;17(2):298-312. doi: 10.1177/1359104511404177. Epub 2011 Jul 14.'}, {'pmid': '26897999', 'type': 'RESULT', 'citation': 'Ferruolo DM. Psychosocial Equine Program for Veterans. Soc Work. 2016 Jan;61(1):53-60. doi: 10.1093/sw/swv054.'}, {'pmid': '32034416', 'type': 'RESULT', 'citation': 'Arnon S, Fisher PW, Pickover A, Lowell A, Turner JB, Hilburn A, Jacob-McVey J, Malajian BE, Farber DG, Hamilton JF, Hamilton A, Markowitz JC, Neria Y. Equine-Assisted Therapy for Veterans with PTSD: Manual Development and Preliminary Findings. Mil Med. 2020 Jun 8;185(5-6):e557-e564. doi: 10.1093/milmed/usz444.'}, {'pmid': '33644617', 'type': 'RESULT', 'citation': 'Marchand WR, Andersen SJ, Smith JE, Hoopes KH, Carlson JK. Equine-Assisted Activities and Therapies for Veterans With Posttraumatic Stress Disorder: Current State, Challenges and Future Directions. Chronic Stress (Thousand Oaks). 2021 Feb 15;5:2470547021991556. doi: 10.1177/2470547021991556. eCollection 2021 Jan-Dec.'}, {'pmid': '30839068', 'type': 'RESULT', 'citation': 'Shelef A, Brafman D, Rosing T, Weizman A, Stryjer R, Barak Y. Equine Assisted Therapy for Patients with Post Traumatic Stress Disorder: A Case Series Study. Mil Med. 2019 Oct 1;184(9-10):394-399. doi: 10.1093/milmed/usz036.'}, {'pmid': '30497951', 'type': 'RESULT', 'citation': 'Burton LE, Qeadan F, Burge MR. Efficacy of equine-assisted psychotherapy in veterans with posttraumatic stress disorder. J Integr Med. 2019 Jan;17(1):14-19. doi: 10.1016/j.joim.2018.11.001. Epub 2018 Nov 16.'}, {'pmid': '30973147', 'type': 'RESULT', 'citation': 'Malinowski K, Yee C, Tevlin JM, Birks EK, Durando MM, Pournajafi-Nazarloo H, Cavaiola AA, McKeever KH. The Effects of Equine Assisted Therapy on Plasma Cortisol and Oxytocin Concentrations and Heart Rate Variability in Horses and Measures of Symptoms of Post-Traumatic Stress Disorder in Veterans. J Equine Vet Sci. 2018 May;64:17-26. doi: 10.1016/j.jevs.2018.01.011. Epub 2018 Feb 12.'}, {'pmid': '29502529', 'type': 'RESULT', 'citation': 'Johnson RA, Albright DL, Marzolf JR, Bibbo JL, Yaglom HD, Crowder SM, Carlisle GK, Willard A, Russell CL, Grindler K, Osterlind S, Wassman M, Harms N. Effects of therapeutic horseback riding on post-traumatic stress disorder in military veterans. Mil Med Res. 2018 Jan 19;5(1):3. doi: 10.1186/s40779-018-0149-6.'}, {'pmid': '29635563', 'type': 'RESULT', 'citation': "Steele E, Wood DS, J Usadi E, Applegarth DM. TRR's Warrior Camp: An Intensive Treatment Program for Combat Trauma in Active Military and Veterans of All Eras. Mil Med. 2018 Mar 1;183(suppl_1):403-407. doi: 10.1093/milmed/usx153."}, {'type': 'RESULT', 'citation': 'Duncan CR, Critchley S, & Marland J. Can Praxis: A model of equine assisted learning (EAL) for PTSD. Canadian Military Journal. 2014; 14(2):64-69.'}, {'pmid': '24458903', 'type': 'RESULT', 'citation': 'Lanning BA, Krenek N. Guest Editorial: Examining effects of equine-assisted activities to help combat veterans improve quality of life. J Rehabil Res Dev. 2013;50(8):vii-xiii. doi: 10.1682/JRRD.2013.07.0159. No abstract available.'}, {'type': 'RESULT', 'citation': 'Lanning BA, Wilson AL, Krenek N, & Beaujean AA. Using therapeutic riding as an intervention for combat Veterans: An international classification of functioning, disability, and health (ICF) approach. Occupational Therapy in Mental Health. 2017; 33(3):259-278. https://doi.org/10.1080/0164212X.2017.1283282'}, {'pmid': '31996299', 'type': 'RESULT', 'citation': 'Sylvia L, West E, Blackburn AM, Gupta C, Bui E, Mahoney T, Duncan G, Wright EC, Lejeune S, Spencer TJ. Acceptability of an adjunct equine-assisted activities and therapies program for veterans with posttraumatic stress disorder and/or traumatic brain injury. J Integr Med. 2020 Mar;18(2):169-173. doi: 10.1016/j.joim.2020.01.005. Epub 2020 Jan 21.'}, {'pmid': '30907609', 'type': 'RESULT', 'citation': 'Wharton T, Whitworth J, Macauley E, Malone M. Pilot testing a manualized equine-facilitated cognitive processing therapy (EF-CPT) intervention for PTSD in veterans. Psychiatr Rehabil J. 2019 Sep;42(3):268-276. doi: 10.1037/prj0000359. Epub 2019 Mar 25.'}, {'pmid': '24963599', 'type': 'RESULT', 'citation': 'Cerulli C, Minganti C, De Santis C, Tranchita E, Quaranta F, Parisi A. Therapeutic horseback riding in breast cancer survivors: a pilot study. J Altern Complement Med. 2014 Aug;20(8):623-9. doi: 10.1089/acm.2014.0061. Epub 2014 Jun 25.'}, {'pmid': '29742908', 'type': 'RESULT', 'citation': 'Fields B, Bruemmer J, Gloeckner G, Wood W. Influence of an Equine-Assisted Activities Program on Dementia-Specific Quality of Life. Am J Alzheimers Dis Other Demen. 2018 Aug;33(5):309-317. doi: 10.1177/1533317518772052. Epub 2018 May 9.'}]}, 'descriptionModule': {'briefSummary': 'Part of the IRB\\_00136053 study was to look at the effectiveness of Warrior Renew and Warrior Renew+EAL interventions. Furthermore, demographic information on Veteran participants will be analyzed.', 'detailedDescription': 'EAL is one of a group of equine-assisted services (EAS), which are aimed at providing benefits for humans, including addressing emotional, mental and social components of functioning. In recent years, the use of EAS has grown rapidly in Europe and the United States in general and is being increasingly used for active-duty military and veteran Veteran populations. As we have previously reviewed, there is evidence that EAS, such as EAL, can contribute to reduction of PTSD and other psychological symptoms as well as enhancing well-being via improvements in resilience, life satisfaction, trust, self-image, and self-control, as well as quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The Veterans who were referred to PTSD team were contacted to see if they wanted to participate in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* referred to PTSD team\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05422768', 'briefTitle': 'PTSD Clinical Team Research Clinic (PCT Research Clinic)', 'organization': {'class': 'FED', 'fullName': 'VA Salt Lake City Health Care System'}, 'officialTitle': 'PTSD Clinical Team Research Clinic (PCT Research Clinic)', 'orgStudyIdInfo': {'id': 'IRB_00136053'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Warrior Renew', 'description': 'Warrior Renew is a program for military sexual trauma (MST).', 'interventionNames': ['Behavioral: Warrior Renew']}, {'label': 'Warrior Renew + EAL', 'description': 'Warrior Renew and EAL are combined into one program for military sexual trauma (MST).', 'interventionNames': ['Behavioral: Warrior Renew + EAL']}], 'interventions': [{'name': 'Warrior Renew', 'type': 'BEHAVIORAL', 'description': 'Warrior Renew is a program for military sexual trauma (MST).', 'armGroupLabels': ['Warrior Renew']}, {'name': 'Warrior Renew + EAL', 'type': 'BEHAVIORAL', 'description': 'Warrior Renew and EAL are combined into one program for military sexual trauma (MST).', 'armGroupLabels': ['Warrior Renew + EAL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84148', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'VA Salt Lake City Health Care System', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Erika Roberge, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Salt Lake City Veterans' Administration Medical Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Salt Lake City Health Care System', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}