Behavior Therapy vs Education for Persistent Headache After Mild TBI

Официальное название

Examining a Novel Treatment for Persistent Headache After Mild Traumatic Brain Injury

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Headache reprocessing
  Behavior therapy focused on sensations and avoidance behaviors
• Поведенческое Headache education
  Education about ways to limit and manage headaches

Первичные конечные точки

• Enrollment rate [Срок оценки: Typically up to 3 months, from initial referral to decision to enroll or not]
• Attrition [Срок оценки: 12 weeks]
• Attendance [Срок оценки: During the 8-week intervention]
• Homework completion [Срок оценки: During the 8-week intervention]
• Credibility/Expectancy Questionnaire [Срок оценки: Week 12]
• Client Satisfaction Questionnaire [Срок оценки: Week 12]
• Adverse events rated to the intervention [Срок оценки: Full study period (28 weeks)]
• Change in Headache Impact Test-6 score [Срок оценки: Week 0 through Week 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• VA San Diego Healthcare System, San Diego, CA — San Diego

Идентификаторы

NCT: NCT07229391 · NURP-008-25S · 1IK2RD001566-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗