Purpose

Evaluation of the overlap between tinnitus-related distress and symptoms of Post Traumatic Stress Disorder (PTSD), to identify functional covariance among resting-state networks among individuals with tinnitus and PTSD

Conditions

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • • Adult military Veterans (age 18-60) who deployed in support of combat operations post-9/11 seeking behavioral health treatment for PTSD and/or tinnitus
  • Diagnosis of PTSD determined by the Clinician-Administered PTSD Scale - Interview - Version 5 (CAPS-5)
  • Ability to speak and read English
  • Meets criteria for tinnitus and considers their tinnitus bothersome, as defined by a score on the Tinnitus Functional Index of 32 or greater

Exclusion Criteria

  • • Currently receiving evidence based treatment for PTSD
  • Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index- Suicidality Subscale and corroborated by a clinical risk assessment by a credentialed provider
  • Psychiatric hospitalization in the last 12 months
  • Current and severe alcohol use warranting immediate intervention based on clinical judgment
  • Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by the manic and psychosis modules of the MINI)
  • Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)
  • Neurobiological disorders
  • Meniere's disease, temporomandibular joint disorders
  • History of seizures
  • History of penetrating head trauma or neurosurgery
  • Metal objects implanted in the head, ferrous metal filings in the eye
  • Inflammation of the brain
  • Cardiac pacemaker
  • Implanted medical pump or cardiac lines
  • Heart disease
  • Currently taking certain types of medication for depression or seizures (tricyclic antidepressants or neuroleptics which lower seizure threshold)

Study Design

Phase
N/A
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Interventional CPT
This study will examine the effectiveness of Cognitive Processing Therapy (CPT) for the alleviation of PTSD and tinnitus-related distress among individuals with co-morbid PTSD and tinnitus.
  • Behavioral: Cognitive Processing Therapy (CPT)
    CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions (Resick, Monson, & Chard, 2017; Resick & Schnicke, 1993). CPT is delivered in three phases: education, processing, and challenging.
    Other names:
    • CPT

Recruiting Locations

UT Health San Antonio
San Antonio, Texas 78229
Contact:
Amanda Flores, BA
210-562-6726
floresa13@uthscsa.edu

More Details

NCT ID
NCT03702166
Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Amanda Flores, BA
210-562-6726
FloresA13@uthscsa.edu

Detailed Description

The purpose of this study is to characterize tinnitus and PTSD symptomatically, neurobiologically, and causally, applying causal modeling to psychometric and neurofunctional data. We will enroll 18 individuals with both tinnitus and PTSD. Participants will be asked to complete baseline assessments of subjective tinnitus distress, PTSD, depression, and resting-state fMRI at baseline. Individuals with comorbid tinnitus and PTSD who are eligible for the study will receive 12 sessions of Cognitive Processing Therapy (CPT) over a 6- to 15-week period. CPT is a trauma-focused treatment for PTSD that guides individuals on how to recognize and challenge thoughts that are erroneous and dysfunctional. One-month follow-up assessments of tinnitus-related distress, PTSD, depression, and anxiety will be conducted, along with resting-state functional magnetic resonance imaging (fMRI).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.