Treatment for PTSD and Tinnitus

The University of Texas System (UT)

Status: Enrolling

Conditions: Posttraumatic Stress Disorder (PTSD); PTSD - Post Traumatic Stress Disorder; Tinnitus

Treatments: Behavioral: Cognitive Processing Therapy; Behavioral: CBT-t

Study type: Interventional

Funder types: Other

Identifiers

NCT07106593

STUDY00001126

HT9425-24-1-0988 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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160 participants in 2 patient groups

CPT-CBTt

Active Comparator group

Description:

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

Treatment:

Behavioral: CBT-t

Behavioral: Cognitive Processing Therapy

CBTt-CPT

Active Comparator group

Description:

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

Treatment:

Behavioral: CBT-t

Behavioral: Cognitive Processing Therapy