Back to resultsNetwork Dysregulation Among Individuals With Comorbid Tinnitus and PTSD
Primary Purpose
Stress Disorders, Post-Traumatic, Tinnitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Processing Therapy (CPT)
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic
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)
Sites / Locations
- UT Health San Antonio
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Interventional CPT
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Depression Symptom Index Suicide Subscale (DSI-SS)
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.
Patient Health Questionnaire-9 (PHQ-9)
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 0-27, where a lower score indicates minimal depression and a higher score indicates severe depression.
Full Information
NCT ID
NCT03702166
First Posted
October 8, 2018
Last Updated
May 4, 2021
Sponsor
The University of Texas Health Science Center at San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT03702166
Brief Title
Network Dysregulation Among Individuals With Comorbid Tinnitus and PTSD
Official Title
Network Dysregulation Among Individuals With Comorbid Tinnitus and PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
August 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Tinnitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional CPT
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy (CPT)
Other Intervention Name(s)
CPT
Intervention Description
CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions. CPT is delivered in three phases: education, processing, and challenging.
Primary Outcome Measure Information:
Title
Change in Score on Clinician Administered PTSD Scale for the DSM-5 (CAPS-5)
Description
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.
Time Frame
Baseline and Week 15
Title
Change in Score on the PTSD Check List-5 (PCL-5)
Description
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.
Time Frame
Baseline and Week 15
Title
Change in Score on the Tinnitus Functional Index (TFI)
Description
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.
Time Frame
Baseline and Week 15
Title
Tinnitus Acceptance Questionnaire (TAQ)
Description
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.
Time Frame
Baseline and Week 15
Secondary Outcome Measure Information:
Title
Depression Symptom Index Suicide Subscale (DSI-SS)
Description
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.
Time Frame
Baseline and Week 15
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
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 0-27, where a lower score indicates minimal depression and a higher score indicates severe depression.
Time Frame
Baseline and Week 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C Moring, PhD
Organizational Affiliation
UT Health San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Health San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Summary results will be shared on ClinicalTrials.gov and will also be shared in publication at study completion.
IPD Sharing Time Frame
Study completion
Learn more about this trial
Network Dysregulation Among Individuals With Comorbid Tinnitus and PTSD
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