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Treatment for PTSD and Tinnitus

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07106593
Enrollment
160
Registered
2025-08-06
Start date
2025-08-08
Completion date
2028-08-31
Last updated
2025-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Sponsors

University of Illinois at Urbana-Champaign
CollaboratorOTHER
The University of Texas Health Science Center at San Antonio
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Participants will either receive Cognitive Processing Therapy (CPT) for PTSD first followed by Cognitive Behavioral Therapy for Tinnitus (CBT-t) for tinnitus; or vice versa: Cognitive Behavioral Therapy for Tinnitus (CBT-t) for tinnitus first followed by Cognitive Processing Therapy (CPT) for PTSD.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PTSD ChecklistBaseline to 6-Month Follow-Up (approximately12 months)Assessment of PTSD Symptoms
Tinnitus Functional IndexBaseline to 6-Month Follow-Up (approximately12 months)Assessment of Tinnitus-Related Distress

Countries

United States

Contacts

Primary ContactAmanda Flores, BA
floresa13@uthscsa.edu210-562-6726

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026