Treatment for PTSD and Tinnitus

NCT ID: NCT07106593

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-08

Study Completion Date

2028-08-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CPT-CBTt

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

Group Type ACTIVE_COMPARATOR

Cognitive Processing Therapy

Intervention Type 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

Intervention Type 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.

CBTt-CPT

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

Group Type ACTIVE_COMPARATOR

Cognitive Processing Therapy

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois at Urbana-Champaign

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Moring, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amanda Flores, BA

Role: CONTACT

210-562-6726

Facility Contacts

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Amanda Flores, BA

Role: primary

210-562-6726

Other Identifiers

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HT9425-24-1-0988

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00001126

Identifier Type: -

Identifier Source: org_study_id

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