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NCT Number: NCT07106593

Treatment for PTSD and Tinnitus

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.

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Key information

Conditions

PTSD - Post Traumatic Stress Disorder Combat Disorders Ear Diseases Hearing Disorders Mental Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Posttraumatic Stress Disorder (PTSD) Sensation Disorders Signs and Symptoms Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Tinnitus Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78240, United States

Location status: Recruiting

Location contact

Amanda Flores, BA

CONTACT

[email protected]

210-562-6726

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive processing therapy

Behavioral

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-t

Behavioral

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 outcomes

  1. PTSD Checklist

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

    Assessment of PTSD Symptoms

  2. Tinnitus Functional Index

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

    Assessment of Tinnitus-Related Distress

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Flores, BA

CONTACT

[email protected]

210-562-6726

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • University of Illinois at Urbana-Champaign

Registry information

Official study title

Treatment of TBI-Related Tinnitus and Comorbid PTSD: Examination of Neurobiological Markers Related to Symptom Improvement

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 6, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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