Treatment for PTSD and Tinnitus
Treatment of TBI-Related Tinnitus and Comorbid PTSD: Examination of Neurobiological Markers Related to Symptom Improvement
2 other identifiers
interventional
160
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2025
CompletedFirst Posted
Study publicly available on registry
August 6, 2025
CompletedStudy Start
First participant enrolled
August 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
August 13, 2025
August 1, 2025
3 years
June 27, 2025
August 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
PTSD Checklist
Assessment of PTSD Symptoms
Baseline to 6-Month Follow-Up (approximately12 months)
Tinnitus Functional Index
Assessment of Tinnitus-Related Distress
Baseline to 6-Month Follow-Up (approximately12 months)
Study Arms (2)
CPT-CBTt
ACTIVE COMPARATORParticipants will receive Cognitive Processing Therapy for PTSD followed by Cognitive Behavioral Therapy for Tinnitus
CBTt-CPT
ACTIVE COMPARATORParticipants will receive Cognitive Behavioral Therapy for Tinnitus followed by Cognitive Processing Therapy for PTSD
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Adult male and female active duty military personnel and veterans seeking treatment for PTSD
- Diagnosis of PTSD
- Person has experienced at least one mild traumatic brain injury (concussion)
- Ability to speak and read English
- Stable on any psychotropic medications
- Meets criteria for chronic subjective and bothersome tinnitus
- Chronic tinnitus is at least possibly related to head injury
You may not qualify if:
- Currently receiving other talk therapies
- Severe hearing loss that would prevent the participant from benefiting from therapy
- Current severe suicidal ideation
- Psychiatric hospitalization in the last 12 months
- Moderate to severe substance use that would prevent the participant form benefiting from therapy
- Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization
- Significant cognitive impairment
- Moderate to severe brain damage
- Neurobiological disorders
- Temporomandibular joint disorders and/or Meniere's disease that cause acute pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78240, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Moring, PhD
The University of Texas Health Science Center at San Antonio
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2025
First Posted
August 6, 2025
Study Start
August 8, 2025
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
August 13, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Unending: Beginning immediately after publication with no end date.
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.