Recruiting

CPT & CBT-t

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT07106593

Conditions

PTSD - Post Traumatic Stress Disorder

Posttraumatic Stress Disorder (PTSD)

Tinnitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Processing Therapy

CBT-t

Study Details

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.

Conditions

PTSD - Post Traumatic Stress Disorder

Posttraumatic Stress Disorder (PTSD)

Tinnitus

Study ID

NCT07106593

Start date

Aug 8, 2025

Status verified date

Aug, 2025

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: CPT-CBTt

Participants will receive Cognitive Processing Therapy for PTSD followed by Cognitive Behavioral Therapy for Tinnitus

active comparator: CBTt-CPT

Participants will receive Cognitive Behavioral Therapy for Tinnitus followed by Cognitive Processing Therapy for PTSD

Interventions

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.

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 measure

  • PTSD Checklist [ Time Frame: Baseline to 6-Month Follow-Up (approximately12 months) ]
  • Tinnitus Functional Index [ Time Frame: Baseline to 6-Month Follow-Up (approximately12 months) ]

Central Contacts and Locations

Central contacts

Amanda Flores, BA

210-562-6726floresa13@uthscsa.edu

Locations

The University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Amanda Flores, BA

210-562-6726FloresA13@uthscsa.edu

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Aug 13, 2025

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2025-08-13.