Network Dysregulation Among Individuals With Comorbid Tinnitus and PTSD

NCT03702166 | Completed Results DMC

• 2 other identifiers: HSC20180524H1KL2TR002646-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Stress Disorders, Post-Traumatic; Tinnitus

Outcome Measures

Primary Outcomes (4)

• Change in Score on Clinician Administered PTSD Scale for the DSM-5 (CAPS-5)

  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.

  Baseline and Week 15

• Change in Score on the PTSD Check List-5 (PCL-5)

  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.

  Baseline and Week 15

• Change in Score on the Tinnitus Functional Index (TFI)

  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 tinnitus interferes more with the subject. The total score is then divided by the number of questions answered to give a mean score. The mean score is multiplied by 10 to provide an overall TFI score within a 0-100 range, where a lower score indicates that the tinnitus does not interfere with the subjects well-being as much.

  Baseline and Week 15

• Tinnitus Acceptance Questionnaire (TAQ)

  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.

  Baseline and Week 15

Secondary Outcomes (2)

• Depression Symptom Index Suicide Subscale (DSI-SS)

  Baseline and Week 15

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline and Week 15

Study Arms (1)

Interventional CPT

OTHER

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)

Interventions

Cognitive Processing Therapy (CPT) BEHAVIORAL

CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions. CPT is delivered in three phases: education, processing, and challenging.

Also known as: CPT

Interventional CPT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Tinnitus

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: John Moring, PhD
• Organization: UT Health San Antonio

moringj@uthscsa.edu

(210) 562-6716

Study Officials

• John C Moring, PhD

  UT Health San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: John Moring, PhD

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 10, 2018
• Study Start: January 4, 2019
• Primary Completion: April 1, 2020
• Study Completion: August 11, 2020
• Last Updated: May 26, 2021
• Results First Posted: December 16, 2020

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study completion

Locations

US (1)