Treatment of TBI-Related Tinnitus and Comorbid PTSD: Examination of Neurobiological Markers Related to Symptom Improvement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- PTSD Checklist
研究概览
简要总结
In this study, researchers are examining the best sequence of interventions for posttraumatic stress disorder (PTSD) and tinnitus. Participants will either receive psychotherapy for PTSD first (Cognitive Processing Therapy; CPT), followed by treatment for tinnitus (Cognitive Behavioral Therapy for Tinnitus; CBT-t); or vice-versa. We also aim to identify changes in brain functioning after receiving therapy.
详细描述
After consenting to this study, study participants will be asked to speak with a study staff member about stressful or traumatic experiences, complete hearing assessments and questionnaires about exposure to traumatic events, PTSD symptoms, mental and physical health problems, such as depression and substance use, head injuries, and tinnitus. Participants who are able and willing may be asked to provide functional magnetic resonance imaging (MRI) scans before and after treatment. Participants will receive treatment for tinnitus and posttraumatic stress disorder (PTSD) in one of two ways: Cognitive Processing Therapy (CPT) first and then Cognitive Behavioral Therapy for Tinnitus (CBT-t) OR CBT-t first, followed by CPT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female active duty military personnel and veterans seeking treatment for PTSD
- •Diagnosis of PTSD
- •Person has experienced at least one mild traumatic brain injury (concussion)
- •Ability to speak and read English
- •Stable on any psychotropic medications
- •Meets criteria for chronic subjective and bothersome tinnitus
- •Chronic tinnitus is at least possibly related to head injury
排除标准
- •Currently receiving other talk therapies
- •Severe hearing loss that would prevent the participant from benefiting from therapy
- •Current severe suicidal ideation
- •Psychiatric hospitalization in the last 12 months
- •Moderate to severe substance use that would prevent the participant form benefiting from therapy
- •Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization
- •Significant cognitive impairment
- •Moderate to severe brain damage
- •Neurobiological disorders
- •Temporomandibular joint disorders and/or Meniere's disease that cause acute pain
研究组 & 干预措施
CPT-CBTt
Participants will receive Cognitive Processing Therapy for PTSD followed by Cognitive Behavioral Therapy for Tinnitus
干预措施: Cognitive Processing Therapy (Behavioral)
CPT-CBTt
Participants will receive Cognitive Processing Therapy for PTSD followed by Cognitive Behavioral Therapy for Tinnitus
干预措施: CBT-t (Behavioral)
CBTt-CPT
Participants will receive Cognitive Behavioral Therapy for Tinnitus followed by Cognitive Processing Therapy for PTSD
干预措施: Cognitive Processing Therapy (Behavioral)
CBTt-CPT
Participants will receive Cognitive Behavioral Therapy for Tinnitus followed by Cognitive Processing Therapy for PTSD
干预措施: CBT-t (Behavioral)
结局指标
主要结局
PTSD Checklist
时间窗: Baseline to 6-Month Follow-Up (approximately12 months)
Assessment of PTSD Symptoms
Tinnitus Functional Index
时间窗: Baseline to 6-Month Follow-Up (approximately12 months)
Assessment of Tinnitus-Related Distress
次要结局
未报告次要终点