Stress Disorders, Post-Traumatic, Tinnitus
Conditions
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).
Interventions
BEHAVIORALCognitive Processing Therapy (CPT)
CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions. CPT is delivered in three phases: education, processing, and challenging.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Score on Clinician Administered PTSD Scale for the DSM-5 (CAPS-5) | 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. |
| Change in Score on the PTSD Check List-5 (PCL-5) | 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. |
| Change in Score on the Tinnitus Functional Index (TFI) | 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 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression Symptom Index Suicide Subscale (DSI-SS) | 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. |
| Patient Health Questionnaire-9 (PHQ-9) | 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 0-27, where a lower score indicates minimal depression and a higher score indicates severe depression. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Cognitive Processing Therapy (CPT): CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions. CPT is delivered in three phases: education, processing, and challenging. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Interventional CPT |
|---|---|
| Age, Continuous | 45.3 Years STANDARD_DEVIATION 9.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 5 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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.
Time frame: Baseline and Week 15
Population: Baseline scores pre-treatment included 10 subjects, post-treatment scores included only 8 subjects who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interventional CPT | Change in Score on Clinician Administered PTSD Scale for the DSM-5 (CAPS-5) | Pre-treatment at baseline | 33.10 score on a scale | Standard Deviation 7.5 |
| Interventional CPT | Change in Score on Clinician Administered PTSD Scale for the DSM-5 (CAPS-5) | Post-treatment at 15 weeks | 16.13 score on a scale | Standard Deviation 14.49 |
p-value: 0.01t-test, 1 sided
Primary
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.
Time frame: Baseline and Week 15
Population: Baseline at pre-treatment included 10 subjects, post-treatment included only 8 subjects who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interventional CPT | Change in Score on the PTSD Check List-5 (PCL-5) | Pre-treatment at baseline | 42.7 score on a scale | Standard Deviation 12.25 |
| Interventional CPT | Change in Score on the PTSD Check List-5 (PCL-5) | Post-treatment at 15 weeks | 17.75 score on a scale | Standard Deviation 18.91 |
Primary
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.
Time frame: Baseline and Week 15
Population: Baseline scores pre-treatment included 10 subjects, post-treatment scores included only 8 subjects who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interventional CPT | Change in Score on the Tinnitus Functional Index (TFI) | Pre-treatment at baseline | 65.16 score on a scale | Standard Deviation 15.97 |
| Interventional CPT | Change in Score on the Tinnitus Functional Index (TFI) | Post-treatment at week 15 | 41.95 score on a scale | Standard Deviation 24.42 |
p-value: 0.038t-test, 1 sided
Primary
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.
Time frame: Baseline and Week 15
Population: Baseline scores pre-treatment included 10 subjects, post-treatment scores included only 8 subjects who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interventional CPT | Tinnitus Acceptance Questionnaire (TAQ) | Pre-treatment at baseline | 35.10 score on a scale | Standard Deviation 8.28 |
| Interventional CPT | Tinnitus Acceptance Questionnaire (TAQ) | Post-treatment at 15 weeks | 46.88 score on a scale | Standard Deviation 13.65 |
Secondary
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.
Time frame: Baseline and Week 15
Population: Baseline scores pre-treatment included 10 subjects, post-treatment scores included only 8 subjects who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interventional CPT | Depression Symptom Index Suicide Subscale (DSI-SS) | Pre-treatment at baseline | 14.10 score on a scale | Standard Deviation 6.59 |
| Interventional CPT | Depression Symptom Index Suicide Subscale (DSI-SS) | Post-treatment at 15 weeks | 7.38 score on a scale | Standard Deviation 4.98 |
p-value: 0.031t-test, 1 sided
Secondary
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.
Time frame: Baseline and Week 15
Population: Baseline scores pre-treatment included 10 subjects, post-treatment scores included only 8 subjects who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interventional CPT | Patient Health Questionnaire-9 (PHQ-9) | Pre-treatment at baseline | 14.10 score on a scale | Standard Deviation 6.59 |
| Interventional CPT | Patient Health Questionnaire-9 (PHQ-9) | Post-treatment at 15 weeks | 7.38 score on a scale | Standard Deviation 4.98 |