Treatment for PTSD and Tinnitus

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: CPT-CBTtActive comparator 2 interventions
Group B: CBTt-CPTActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

PTSD Checklist

Assessment of PTSD Symptoms

Time frame
Baseline to 6-Month Follow-Up (approximately12 months)
2

Tinnitus Functional Index

Assessment of Tinnitus-Related Distress

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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The University of Texas Health Science Center at San Antonio

Lead sponsor

University of Illinois at Urbana-Champaign

Collaborator