PTSD - Post Traumatic Stress DisorderNCT07106593
Treatment for PTSD and Tinnitus
A study testing Cognitive Processing Therapy and CBT-t in people with PTSD - Post Traumatic Stress Disorder and Posttraumatic Stress Disorder (PTSD), run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder, Posttraumatic Stress Disorder (PTSD), Tinnitus
- What is being tested?
- Cognitive Processing Therapy and CBT-t
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2025to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Significant cognitive impairment
- Moderate to severe brain damage
- Neurobiological disorders
- Temporomandibular joint disorders and/or Meniere's disease that cause acute pain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78240
Amanda Flores, BA, 210-562-6726, FloresA13@uthscsa.edu
About this study
Official title: Treatment of TBI-Related Tinnitus and Comorbid PTSD: Examination of Neurobiological Markers Related to Symptom Improvement
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.
Read the detailed description
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.
- Being tested
- Cognitive Processing Therapy, CBT-t
- Keywords
- imaging, veterans, active duty, ptsd, tinnitus, treatment, cognitive processing therapy, cognitive behavioral therapy for tinnitus, military, psychotherapy, therapy, counseling
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing TherapyBehavioural
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.
CBT-tBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CPT-CBTt | Active comparator | Participants will receive Cognitive Processing Therapy for PTSD followed by Cognitive Behavioral Therapy for Tinnitus Receives: Behavioral: Cognitive Processing Therapy; Behavioral: CBT-t |
| CBTt-CPT | Active comparator | Participants will receive Cognitive Behavioral Therapy for Tinnitus followed by Cognitive Processing Therapy for PTSD Receives: Behavioral: Cognitive Processing Therapy; Behavioral: CBT-t |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist
Assessment of PTSD Symptoms
Measured: Baseline to 6-Month Follow-Up (approximately12 months)
Tinnitus Functional Index
Assessment of Tinnitus-Related Distress
Measured: Baseline to 6-Month Follow-Up (approximately12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start8 Aug 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Responsible party
- Sponsor
- Investigators
- John Moring, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106593
- Sponsor's protocol ID
- STUDY00001126
- Other IDs
- HT9425-24-1-0988
- Status last verified
- Sep 2026
- First submitted
- 27 Jun 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of TBI-Related Tinnitus and Comorbid PTSD: Examination of Neurobiological Markers Related to Symptom Improvement
- ClinicalTrials.gov ID
- NCT07106593
- Acronym / sponsor ID
- STUDY00001126
- Keywords
- imaging, veterans, active duty, ptsd, tinnitus, treatment, cognitive processing therapy, cognitive behavioral therapy for tinnitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CPT-CBTt | Active comparator | Behavioral: Cognitive Processing Therapy, Behavioral: CBT-tParticipants will receive Cognitive Processing Therapy for PTSD followed by Cognitive Behavioral Therapy for Tinnitus |
| CBTt-CPT | Active comparator | Behavioral: Cognitive Processing Therapy, Behavioral: CBT-tParticipants will receive Cognitive Behavioral Therapy for Tinnitus followed by Cognitive Processing Therapy for PTSD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Processing TherapyCPT (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. | Behavioural | CBTt-CPT, CPT-CBTt |
| CBT-tThe 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. | Behavioural | CBTt-CPT, CPT-CBTt |
Primary outcome
PTSD Checklist
Time frame: Baseline to 6-Month Follow-Up (approximately12 months)
Assessment of PTSD Symptoms
Tinnitus Functional Index
Time frame: Baseline to 6-Month Follow-Up (approximately12 months)
Assessment of Tinnitus-Related Distress
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Moring, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Processing Therapy and CBT-t in people with PTSD - Post Traumatic Stress Disorder and Posttraumatic Stress Disorder (PTSD), run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Flores, BA (210-562-6726, floresa13@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist (time frame: Baseline to 6-Month Follow-Up (approximately12 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.