Network Dysregulation Among Individuals With Comorbid Tinnitus and PTSD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Score on Clinician Administered PTSD Scale for the DSM-5 (CAPS-5)
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Change in Score on Clinician Administered PTSD Scale for the DSM-5 (CAPS-5)
时间窗: 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)
时间窗: 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.
Tinnitus Acceptance Questionnaire (TAQ)
时间窗: 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.
Change in Score on the Tinnitus Functional Index (TFI)
时间窗: 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.
次要结局
- Depression Symptom Index Suicide Subscale (DSI-SS)(Baseline and Week 15)
- Patient Health Questionnaire-9 (PHQ-9)(Baseline and Week 15)
研究者
John Moring
John Moring, PhD
The University of Texas Health Science Center at San Antonio