N/A
N=10
Network Dysregulation Among Individuals With Comorbid Tinnitus and PTSD
Stress Disorders, Post-Traumatic · Tinnitus
Bottom Line
View on ClinicalTrials.gov: NCT03702166 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Change in Score on Clinician Administered PTSD Scale for the DSM-5 (CAPS-5) — 33.10; 16.13 score on a scale — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Processing Therapy (CPT) (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Score on Clinician Administered PTSD Scale for the DSM-5 (CAPS-5) |
33.10; 16.13 | 0.01 sig |
| PRIMARY Change in Score on the PTSD Check List-5 (PCL-5) |
42.7; 17.75 | — |
| PRIMARY Change in Score on the Tinnitus Functional Index (TFI) |
65.16; 41.95 | 0.038 sig |
| PRIMARY Tinnitus Acceptance Questionnaire (TAQ) |
35.10; 46.88 | — |
| SECONDARY Depression Symptom Index Suicide Subscale (DSI-SS) |
14.10; 7.38 | 0.031 sig |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) |
14.10; 7.38 | — |
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
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)
Data sourced from ClinicalTrials.gov (NCT03702166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.