Treatment for PTSD and Tinnitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Processing Therapy, CBT-t.
- Who it may be relevant to
- Registry conditions: PTSD - Post Traumatic Stress Disorder, Posttraumatic Stress Disorder (PTSD), Tinnitus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Treatment of TBI-Related Tinnitus and Comorbid PTSD: Examination of Neurobiological Markers Related to Symptom Improvement
Overview
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
- Behavioral 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. - 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 p
Primary outcome measures
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The University of Texas Health Science Center at San Antonio — San Antonio
Identifiers
NCT: NCT07106593 · STUDY00001126 · HT9425-24-1-0988