Network Dysregulation Among Individuals With Comorbid Tinnitus and PTSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03702166
Recruitment Status : Not yet recruiting
First Posted : October 10, 2018
Last Update Posted : November 29, 2018
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

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

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Tinnitus Behavioral: Cognitive Processing Therapy (CPT) Not Applicable

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 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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Network Dysregulation Among Individuals With Comorbid Tinnitus and PTSD
Estimated Study Start Date : January 4, 2019
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Interventional CPT
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)
CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions (Resick, Monson, & Chard, 2017; Resick & Schnicke, 1993). CPT is delivered in three phases: education, processing, and challenging.
Other Name: CPT

Primary Outcome Measures :
  1. Change in Score on Clinician Administered PTSD Scale for the DSM-5 (CAPS-5) [ Time Frame: Change from Baseline to Week 15 ]
    The CAPS-5 is structured interview that assesses the DSM-5 criteria for PTSD (Weathers et al., 2013). 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.

  2. Change in Score on the PTSD Check List-5 (PCL-5) [ Time Frame: Change from Baseline to Week 15 ]
    The PCL-5 (Weathers, et al., 2010) is a 20-item self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5 (The Diagnostic and Statistical Manual of Mental Disorders). 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).

  3. Change in Score on the Tinnitus Functional Index (TFI) [ Time Frame: Change from Baseline to Week 15 ]
    The TFI (Henry et al., 2014) has 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.

  4. Tinnitus Acceptance Questionnaire (TAQ) [ Time Frame: Change from Baseline to Week 15 ]
    The TAQ (Westin et al., 2008) 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.

Secondary Outcome Measures :
  1. Depression Symptom Index Suicide Subscale (DSI-SS) [ Time Frame: Change from Baseline to Week 15 ]
    The DSI-SS (Metalsky & Joiner, 1997) 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.

  2. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Change from Baseline to Week 15 ]
    The PHQ-9 (Kroenke, Spitzer, & Williams, 2001) 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).

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes

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)

Responsible Party: The University of Texas Health Science Center at San Antonio Identifier: NCT03702166     History of Changes
Other Study ID Numbers: HSC20180524H
1KL2TR002646-01 ( U.S. NIH Grant/Contract )
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders