Clinical Trial: Cognitive-Behavior Therapy for Posttraumatic Headache
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Coalition to Alleviate PTSD: Randomized Clinical Trial of Cognitive-Behavior Therapy for Posttraumatic Headache
Brief Summary: The overall purpose of the study is to compare two talk therapies (Clinic-Based Cognitive Behavioral Therapy and Cognitive Processing Therapy-Cognitive Only) for the treatment of posttraumatic headache (PTHA) and co-morbid posttraumatic stress (PTS). The researchers hope to learn if a non-medication, cognitive-behavioral treatment can result in noticeable reductions in PTHA intensity/severity and frequency as well as PTS symptom severity.
Detailed Summary:
More than 100,000 military service members and veterans suffer from chronic headaches resulting from a traumatic brain injury (TBI) sustained during deployment. Although that population has seen a sharp increase in these posttraumatic headaches (PTHA), the condition is extraordinarily difficult to treat. There is very little evidence guiding its management.
Complicating things is the fact that those who have suffered a traumatic injury during deployment often have co-occurring symptoms of posttraumatic stress, which may worsen their headaches or make them more difficult to treat.
To better inform our understanding of how to help our suffering war veterans, we developed a study for the Consortium to Alleviate PTSD (CAP) addressing posttraumatic headache in war veterans with co-occurring symptoms of posttraumatic stress.
A key aim of the study will be to evaluate whether a leading psychological therapy for migraine headaches is effective with posttraumatic headaches. Investigators also seek to determine if treatment for PTHA likewise improves problems with PTSD, and whether treatment for PTSD simultaneously alleviates headaches.
To accomplish these aims, the study will have three arms, with participants placed randomly into one of three treatment conditions:
- Treatment as usual (e.g., receiving standard care for PTHA through the South Texas Veterans Health Care System's Polytrauma Rehabilitation Center in San Antonio);
- A gold standard, manualized cognitive-behavioral intervention for headache; or
- A gold-standard treatment for PTSD, called Cognitive Processing Therapy.
Sponsor: Wake Forest University Health Sciences
Current Primary Outcome: Headache-related disability scores on the Headache Impact Test 6 (HIT-6) [ Time Frame: Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Frequency of headache reported in daily diary records [ Time Frame: Twice daily for two weeks at baseline, twice daily during 6 weeks of treatment, and twice daily for two week periods at 3 and 6 months post-treatment ]Change in headache frequency over time (averaged over two-week intervals) from baseline, at the completion of 6 weeks of treatment, and at 3 and 6 months post-treatment. Participants will complete headache diaries twice daily (am and pm) via a secure online patient reporting website developed for this study and managed by study staff. A total of 168 daily diary entries will be collected during the study period
- Scores for symptoms of post-traumatic stress on the PTSD Checklist-5 (PCL-5) [ Time Frame: Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment ]Change in baseline post-traumatic stress scores will be assessed over time based on reports of post-traumatic stress symptoms on the PTSD-checklist (PCL-5) obtained at multiple time points: at the end of 6 weeks of treatment, and at 3 and 6 months post-treatment.
Original Secondary Outcome: Same as current
Information By: Wake Forest University Health Sciences
Dates:
Date Received: April 9, 2015
Date Started: May 2015
Date Completion: December 2018
Last Updated: November 1, 2016
Last Verified: November 2016
