Study Results
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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RECRUITING
NA
160 participants
INTERVENTIONAL
2025-08-08
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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CPT-CBTt
Participants will receive Cognitive Processing Therapy for PTSD followed by Cognitive Behavioral Therapy for Tinnitus
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.
CBTt-CPT
Participants will receive Cognitive Behavioral Therapy for Tinnitus followed by Cognitive Processing Therapy for PTSD
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Illinois at Urbana-Champaign
OTHER
The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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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