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RecruitingNCT07106593Updated Sep 25, 2026

Treatment for PTSD and Tinnitus

An interventional study of Cognitive Processing Therapy and CBT-t in PTSD - Post Traumatic Stress Disorder, Posttraumatic Stress Disorder (PTSD) and Tinnitus, sponsored by The University of Texas Health Science Center at San Antonio. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • PTSD - Post Traumatic Stress Disorder
  • Posttraumatic Stress Disorder (PTSD)
  • Tinnitus

Keywords

  • imaging
  • veterans
  • active duty
  • ptsd
  • tinnitus
  • treatment
  • cognitive processing therapy
  • cognitive behavioral therapy for tinnitus
  • military
  • psychotherapy
  • therapy
  • counseling
03

In context

Combat Disorders

200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.

This study's planned enrollment of 160 is above the median of 72 across 167 interventional studies indexed under Combat Disorders.

Browse Combat Disorders studies →

Lead sponsor

The University of Texas Health Science Center at San Antonio is the lead sponsor of 445 studies on the registry; 89 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 35 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Active comparator
    CPT-CBTt

    Participants will receive Cognitive Processing Therapy for PTSD followed by Cognitive Behavioral Therapy for Tinnitus

    Behavioral: Cognitive Processing Therapy · Behavioral: CBT-t

  • Active comparator
    CBTt-CPT

    Participants will receive Cognitive Behavioral Therapy for Tinnitus followed by Cognitive Processing Therapy for PTSD

    Behavioral: Cognitive Processing Therapy · Behavioral: CBT-t

Interventions

  • BehavioralCognitive Processing Therapy

    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.

  • BehavioralCBT-t

    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.

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What researchers measure

Primary outcomes

  1. PTSD Checklist

    Assessment of PTSD Symptoms

    Time frame: Baseline to 6-Month Follow-Up (approximately12 months)

  2. Tinnitus Functional Index

    Assessment of Tinnitus-Related Distress

    Time frame: Baseline to 6-Month Follow-Up (approximately12 months)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan

Time frame: Unending: Beginning immediately after publication with no end date.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07106593
Responsible party
Sponsor
First posted
Aug 6, 2025
Start date
Aug 8, 2025
Primary completion
Aug 2028 (estimated)
Completion
Aug 2028 (estimated)
Last update
Sep 25, 2026

Study contacts

Amanda Flores, BA
Contact
floresa13@uthscsa.edu
210-562-6726
John Moring, PhD
principal investigator · The University of Texas Health Science Center at San Antonio

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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