Treatment for PTSD and Tinnitus

Not Applicable

Recruiting

• Conditions: PTSD - Post Traumatic Stress Disorder; Posttraumatic Stress Disorder (PTSD); Tinnitus

• Registration Number: NCT07106593
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief 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.

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 Timeline

• Study First Submitted: 2025-06-27
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-05
• Study First Posted: 2025-08-06
• Study Start: 2025-08-08
• Last Update Submitted: 2025-08-08
• Last Update Posted: 2025-08-13
• Primary Completion: 2028-08
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
PTSD Checklist	Baseline to 6-Month Follow-Up (approximately12 months)	Assessment of PTSD Symptoms
Tinnitus Functional Index	Baseline to 6-Month Follow-Up (approximately12 months)	Assessment of Tinnitus-Related Distress

Trial Locations

Locations (1)

The University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States