NCT07106593 · The University of Texas Health Science Center at San Antonio
Treatment for PTSD and Tinnitus
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Cognitive 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.
BEHAVIORAL
CBT-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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- San Antonio, Texas
Collaborators
University of Illinois at Urbana-Champaign
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 13, 2025 · Source of record for eligibility and locations