Deciding whether PTSD therapy or tinnitus therapy should come first for people with both conditions.
Treatment of TBI-Related Tinnitus and Comorbid PTSD: Examination of Neurobiological Markers Related to Symptom Improvement
This project will try giving either PTSD therapy first then tinnitus therapy, or tinnitus therapy first then PTSD therapy, in veterans and active-duty adults with PTSD and bothersome chronic tinnitus to see which order helps more.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT07106593 on ClinicalTrials.gov |
What this trial studies
Adults with PTSD and chronic, bothersome tinnitus—often following a head injury—are enrolled and assigned to receive Cognitive Processing Therapy (CPT) and Cognitive Behavioral Therapy for Tinnitus (CBT-t) in one of two sequences: CPT first then CBT-t, or CBT-t first then CPT. Before and after treatment participants complete hearing exams and questionnaires about trauma exposure, PTSD symptoms, mood, substance use, head injury history, and tinnitus impact. Eligible and willing participants may also have functional MRI scans before and after treatment to measure changes in brain function. The study compares symptom and imaging changes to determine whether the order of therapies affects outcomes.
Who should consider this trial
Good fit: Adult active-duty military personnel or veterans with diagnosed PTSD, a history of at least one mild traumatic brain injury, and chronic bothersome tinnitus who can read and speak English and are stable on psychotropic medications.
Not a fit: People with severe hearing loss, recent psychiatric hospitalization, severe suicidal ideation, uncontrolled substance use, active manic or psychotic episodes, significant cognitive impairment, or moderate-to-severe brain damage are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this work could tell clinicians which treatment order reduces PTSD and tinnitus symptoms more and improve care planning for veterans and active-duty patients with both conditions.
How similar studies have performed: Cognitive Processing Therapy for PTSD and CBT for tinnitus each have evidence when used alone, but using one then the other to treat both conditions together is less well studied and relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * 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
Where this trial is running
San Antonio, Texas
- The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: John Moring, PhD — The University of Texas Health Science Center at San Antonio
- Study coordinator: Amanda Flores, BA
- Email: floresa13@uthscsa.edu
- Phone: 210-562-6726
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.