Examining a Novel Treatment for Persistent Headache After Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Enrollment rate
研究概览
简要总结
This study will test a new treatment, called Headache reprocessing, for persistent post-traumatic headache. The new treatment will be compared to a headache education intervention. The main objectives of the study are to examine the feasibility, safety, and clinical appropriateness of the new treatment.
详细描述
Persistent post-traumatic headache (PPTH) is a common, debilitating health condition affecting Veterans and civilians. Relative to other headache disorders, PPTH is especially severe and impairing. PPTH has no established first-line treatments at this time. This research seeks to develop a new behavioral treatment, called headache reprocessing, to target fear and avoidance behaviors and cognitions, and associated neural changes, that drive PPTH. This trial will test the feasibility, safety, and clinical appropriateness of Headache Reprocessing Therapy by comparing it to a headache education control condition in a randomized controlled trial. We will randomize 60 Veterans with PPTH to take part in this study. Headache reprocessing and the educational control intervention will be delivered in group format over eight sessions (one per week for eight weeks). This intervention has the potential to improve available treatment options for PPTH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Enrolled in healthcare at VA San Diego Healthcare System;
- •History of mild TBI (mTBI), or head injury that is below the diagnostic threshold for mTBI
- •Headache that had its lifetime onset or significantly worsened within 90 days of a concussive event
- •Headache has persisted for at least 90 days since its onset or worsening
- •No changes in past 3 months to medical management of headache or comorbid psychiatric symptoms, and no anticipated changes during the study interval
- •No current participation in psychological intervention for pain or headache
排除标准
- •History of moderate or severe traumatic brain injury
- •Uncontrolled bipolar, psychotic, or substance use disorder
- •Acute suicidality as determined by screening as "high risk" or has a history of suicide attempt within the past 1 year;
- •Other factors that would preclude participation in the study
研究组 & 干预措施
Headache reprocessing
Behavior therapy focused on sensations and avoidance behaviors
干预措施: Headache reprocessing (Behavioral)
Headache education
Education about ways to limit and manage headaches
干预措施: Headache education (Behavioral)
结局指标
主要结局
Enrollment rate
时间窗: Typically up to 3 months, from initial referral to decision to enroll or not
Number enrolled out of number approached
Attrition
时间窗: 12 weeks
% of randomized who are lost to follow-up before week 12
Attendance
时间窗: During the 8-week intervention
Percent of participants attending 80+% of sessions
Homework completion
时间窗: During the 8-week intervention
Percent of participants completing 80+% of homework
Credibility/Expectancy Questionnaire
时间窗: Week 12
Scale measuring how credible the intervention seemed to participants
Client Satisfaction Questionnaire
时间窗: Week 12
Scale measuring participant satisfaction with the intervention
Adverse events rated to the intervention
时间窗: Full study period (28 weeks)
Adverse events determined to be caused by the intervention
Change in Headache Impact Test-6 score
时间窗: Week 0 through Week 12
A widely-used scale measuring the impact that headaches have on daily life.
次要结局
未报告次要终点