The University of Texas Health Science Center at San Antonio
Who can join
Adults 18 to 60, any sex, with Stress Disorders, Post-Traumatic or Tinnitus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Score on Clinician Administered PTSD Scale for the DSM-5 (CAPS-5)Primary· Baseline and Week 15
The CAPS-5 is structured interview that assesses the DSM-5 criteria for PTSD. Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms. Total scores range from 0-80 with a lower score indicating less symptoms of PTSD. Subscales were not utilized in analyses.
Pre-treatment at baseline
Group
Value
95% CI
Interventional CPT
33.10
± 7.50
Post-treatment at 15 weeks
Group
Value
95% CI
Interventional CPT
16.13
± 14.49
Change in Score on the PTSD Check List-5 (PCL-5)Primary· Baseline and Week 15
The PCL-5 is a 20-item self-report measure designed to assess PTSD symptoms. The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past month (for baseline and follow up assessments) as a result of a specific life event. Each item of the PCL-5 is scored on a five point scale ranging from 0 ("not at all") to 4 ("extremely). Possible total score range is 0-80, with a lower score indicating less PTSD symptoms. Subscales were not utilized in analyses.
Pre-treatment at baseline
Group
Value
95% CI
Interventional CPT
42.7
± 12.25
Post-treatment at 15 weeks
Group
Value
95% CI
Interventional CPT
17.75
± 18.91
Change in Score on the Tinnitus Functional Index (TFI)Primary· Baseline and Week 15
The TFI has 25 items that are used to calculate eight subscales that address the intrusiveness of tinnitus, the sense of control the patient has, cognitive interference, sleep disturbance, auditory issues, relaxation issues, quality of life, and emotional distress related to tinnitus. The same 25 items are used to calculate the total score, which was used for the purpose of this study. For the total score, the 25 scale items are scored 0-10 (those scored as a percentage are converted to a score of 1-10). Scores are totaled giving a potential range of 0-250 with a higher score indicating that t
Pre-treatment at baseline
Group
Value
95% CI
Interventional CPT
65.16
± 15.97
Post-treatment at week 15
Group
Value
95% CI
Interventional CPT
41.95
± 24.42
Tinnitus Acceptance Questionnaire (TAQ)Primary· Baseline and Week 15
The TAQ captures the extent to which individuals accept their tinnitus, and attempts to avoid or control tinnitus, as well as a patient's ability to pursue valued life activities and meaningful goals regardless of tinnitus. 12 questions are scored from 0 = Never true to 6= Always true. Total scores on the TAQ range from 0-72, with a lower score indicating higher acceptance of symptoms.
Pre-treatment at baseline
Group
Value
95% CI
Interventional CPT
35.10
± 8.28
Post-treatment at 15 weeks
Group
Value
95% CI
Interventional CPT
46.88
± 13.65
Depression Symptom Index Suicide Subscale (DSI-SS)Secondary· Baseline and Week 15
The DSI-SS will be used to assess current suicidal ideation. The DSI-SS is a 4-item self-report measure of suicidal ideation that focuses on ideation, plans, perceived control over ideation, and impulses for suicide. Each item is rated on a 4 point scale, and the scores totaled for a potential range of 4-16, where a higher score indicates more severe degrees of suicide ideation.
Pre-treatment at baseline
Group
Value
95% CI
Interventional CPT
14.10
± 6.59
Post-treatment at 15 weeks
Group
Value
95% CI
Interventional CPT
7.38
± 4.98
Patient Health Questionnaire-9 (PHQ-9)Secondary· Baseline and Week 15
The PHQ-9 is a widely used and well-validated instrument for measuring the severity of depressive symptoms. It consists of 9 items that assess both affective and somatic symptoms related to depression and depressive disorders that correspond to the diagnostic criteria for Major Depressive Disorder, outlined by the Diagnostic and Statistical Manual of Mental Disorders- 5th Edition (DSM-V, 2013). Each question is rated with a score of 0-3:
0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. Scores are the total for the nine questions with a possible range of 0-2
Pre-treatment at baseline
Group
Value
95% CI
Interventional CPT
14.10
± 6.59
Post-treatment at 15 weeks
Group
Value
95% CI
Interventional CPT
7.38
± 4.98
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline to 15 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio
Last refreshed: 26 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03702166.