Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-27 @ 1:31 AM
Study NCT ID:
NCT07106593
Status:
RECRUITING
Last Update Posted:
2025-08-13
First Post:
2025-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment for PTSD and Tinnitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003130', 'term': 'Combat Disorders'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D014012', 'term': 'Tinnitus'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Participants will either receive Cognitive Processing Therapy (CPT) for PTSD first followed by Cognitive Behavioral Therapy for Tinnitus (CBT-t) for tinnitus; or vice versa: Cognitive Behavioral Therapy for Tinnitus (CBT-t) for tinnitus first followed by Cognitive Processing Therapy (CPT) for PTSD.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2025-06-27', 'studyFirstSubmitQcDate': '2025-08-05', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PTSD Checklist', 'timeFrame': 'Baseline to 6-Month Follow-Up (approximately12 months)', 'description': 'Assessment of PTSD Symptoms'}, {'measure': 'Tinnitus Functional Index', 'timeFrame': 'Baseline to 6-Month Follow-Up (approximately12 months)', 'description': 'Assessment of Tinnitus-Related Distress'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['imaging', 'veterans', 'active duty', 'ptsd', 'tinnitus', 'treatment', 'cognitive processing therapy', 'cognitive behavioral therapy for tinnitus', 'military', 'psychotherapy', 'therapy', 'counseling'], 'conditions': ['PTSD - Post Traumatic Stress Disorder', 'Posttraumatic Stress Disorder (PTSD)', 'Tinnitus']}, 'descriptionModule': {'briefSummary': 'In this study, researchers are examining the best sequence of interventions for posttraumatic stress disorder (PTSD) and tinnitus. Participants will either receive psychotherapy for PTSD first (Cognitive Processing Therapy; CPT), followed by treatment for tinnitus (Cognitive Behavioral Therapy for Tinnitus; CBT-t); or vice-versa. We also aim to identify changes in brain functioning after receiving therapy.', 'detailedDescription': 'After consenting to this study, study participants will be asked to speak with a study staff member about stressful or traumatic experiences, complete hearing assessments and questionnaires about exposure to traumatic events, PTSD symptoms, mental and physical health problems, such as depression and substance use, head injuries, and tinnitus. Participants who are able and willing may be asked to provide functional magnetic resonance imaging (MRI) scans before and after treatment. Participants will receive treatment for tinnitus and posttraumatic stress disorder (PTSD) in one of two ways: Cognitive Processing Therapy (CPT) first and then Cognitive Behavioral Therapy for Tinnitus (CBT-t) OR CBT-t first, followed by CPT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult male and female active duty military personnel and veterans seeking treatment for PTSD\n* Diagnosis of PTSD\n* Person has experienced at least one mild traumatic brain injury (concussion)\n* Ability to speak and read English\n* Stable on any psychotropic medications\n* Meets criteria for chronic subjective and bothersome tinnitus\n* Chronic tinnitus is at least possibly related to head injury\n\nExclusion Criteria:\n\n* Currently receiving other talk therapies\n* Severe hearing loss that would prevent the participant from benefiting from therapy\n* Current severe suicidal ideation\n* Psychiatric hospitalization in the last 12 months\n* Moderate to severe substance use that would prevent the participant form benefiting from therapy\n* Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization\n* Significant cognitive impairment\n* Moderate to severe brain damage\n* Neurobiological disorders\n* Temporomandibular joint disorders and/or Meniere's disease that cause acute pain"}, 'identificationModule': {'nctId': 'NCT07106593', 'briefTitle': 'Treatment for PTSD and Tinnitus', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'Treatment of TBI-Related Tinnitus and Comorbid PTSD: Examination of Neurobiological Markers Related to Symptom Improvement', 'orgStudyIdInfo': {'id': 'STUDY00001126'}, 'secondaryIdInfos': [{'id': 'HT9425-24-1-0988', 'type': 'OTHER_GRANT', 'domain': 'DoD CDMRP Traumatic Brain Injury and Psychological Health Research Program 2023'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CPT-CBTt', 'description': 'Participants will receive Cognitive Processing Therapy for PTSD followed by Cognitive Behavioral Therapy for Tinnitus', 'interventionNames': ['Behavioral: Cognitive Processing Therapy', 'Behavioral: CBT-t']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CBTt-CPT', 'description': 'Participants will receive Cognitive Behavioral Therapy for Tinnitus followed by Cognitive Processing Therapy for PTSD', 'interventionNames': ['Behavioral: Cognitive Processing Therapy', 'Behavioral: CBT-t']}], 'interventions': [{'name': 'Cognitive Processing Therapy', 'type': 'BEHAVIORAL', 'description': 'CPT (Resick, Monson, \\& Chard, 2024) consists of 12 50-minute sessions conducted over a 6- to 12-week period (Resick, Monson, \\& Chard, 2008). The three phases of CPT include psychoeducation, processing, and challenging beliefs and assumptions related to the trauma, oneself, and the world.', 'armGroupLabels': ['CBTt-CPT', 'CPT-CBTt']}, {'name': 'CBT-t', 'type': 'BEHAVIORAL', 'description': 'The standard CBT-t protocol is gathered from the Progressive Tinnitus Management (PTM) program, and includes psychoeducation about how tinnitus can develop. CBT-t includes using behavioral principles to help manage tinnitus reactions, including the use of sounds: soothing sounds, background sound, and interesting sound. CBT-t teaches relaxation exercises, scheduling pleasant activities, and learn how to modify thoughts related to tinnitus. Therapists will also provide basic education on how to protect hearing health among participants in order to prevent worsening of tinnitus and to prevent exacerbation of any hearing loss.', 'armGroupLabels': ['CBTt-CPT', 'CPT-CBTt']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amanda Flores, BA', 'role': 'CONTACT', 'email': 'FloresA13@uthscsa.edu', 'phone': '210-562-6726'}], 'facility': 'The University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Amanda Flores, BA', 'role': 'CONTACT', 'email': 'floresa13@uthscsa.edu', 'phone': '210-562-6726'}], 'overallOfficials': [{'name': 'John Moring, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center at San Antonio'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Unending: Beginning immediately after publication with no end date.', 'ipdSharing': 'YES', 'description': 'At the conclusion of this study, participants who signed the consent to have their data placed in the STRONG STAR Repository will be maintained under the UTHSCSA IRB-approved Repository protocol. For participants who decline participation in the STRONG STAR Repository, at the conclusion of the study their data will be de-identified and the data maintained in the Repository without identifiers. The IRB approved STRONG STAR Repository is a large comprehensive database of information, biological specimens and neuroimages related to the identification, assessment, and treatment of posttraumatic stress disorder (PTSD), insomnia, pain, and related behavioral health conditions. No biospecimen data is being collected in this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Illinois at Urbana-Champaign', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}