Clinical trial NCT03702166: Network Dysregulation Among Individuals With Comorbid Tinnitus and PTSD
Official title: Network Dysregulation Among Individuals With Comorbid Tinnitus and PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Tinnitus
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2018-10-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

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 30 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Score on Clinician Administered PTSD Scale for the DSM-5 (CAPS-5)
timeFrame: Baseline and Week 15
measure: Change in Score on the PTSD Check List-5 (PCL-5)
timeFrame: Baseline and Week 15
measure: Change in Score on the Tinnitus Functional Index (TFI)
timeFrame: Baseline and Week 15
measure: Tinnitus Acceptance Questionnaire (TAQ)
timeFrame: Baseline and Week 15
Secondary outcomes:
measure: Depression Symptom Index Suicide Subscale (DSI-SS)
timeFrame: Baseline and Week 15
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline and Week 15
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
Study officials:
affiliation: UT Health San Antonio
name: John C Moring, PhD
role: PRINCIPAL_INVESTIGATOR
References: