Network Dysregulation Among Individuals With Comorbid Tinnitus and PTSD



Status:Recruiting
Conditions:Other Indications, Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - 50
Updated:1/18/2019
Start Date:January 4, 2019
End Date:June 30, 2020
Contact:Amanda Flores, BA
Email:FloresA13@uthscsa.edu
Phone:210-562-6726

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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

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).

Inclusion Criteria:

- • Adult male military Veterans (age 18-50) 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)
We found this trial at
1
site
7703 Floyd Curl Drive
San Antonio, Texas 78229
Phone: 210-562-6726
?
mi
from
San Antonio, TX
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