PTSD Clinical Trial - Cognitive-Behavior Therapy for Posttraumatic

Status Completed

Clinical Trial 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.

Clinical Trial Description

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:

1. 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);

2. A gold standard, manualized cognitive-behavioral intervention for headache; or

3. A gold-standard treatment for PTSD, called Cognitive Processing Therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02419131
Study type	Interventional
Source	The University of Texas Health Science Center at San Antonio
Contact
Status	Completed
Phase	N/A
Start date	May 1, 2015
Completion date	October 10, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Cognitive-Behavior Therapy for Posttraumatic Headache

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms