An interventional study of Behavioral Headache Therapy and Cognitive Processing Therapy in Post-traumatic Headache and PTSD, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Treatment
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.
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:
188 studies on the registry are indexed under Post-Traumatic Headache; 51 are open to participants now.
This study's enrollment of 193 is above the median of 44 across 166 interventional studies indexed under Post-Traumatic Headache.
Browse Post-Traumatic Headache studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A standard, manualized behavioral intervention for primary headache disorders
Behavioral: Behavioral Headache Therapy
A gold-standard treatment for PTSD, called Cognitive Processing Therapy
Behavioral: Cognitive Processing Therapy
Treatment as usual, receiving standard care for PTHA
Behavioral: Treatment as Usual
A standard, manualized behavioral intervention for primary headache disorders
A gold-standard treatment for PTSD, called Cognitive Processing Therapy
Treatment as usual, receiving standard care for PTHA
Headache-related Disability Scores on the Headache Impact Test 6 (HIT-6)
Baseline headache-related disability will be assessed over time based on headache-related disability scores on the HIT-6 obtained at multiple time points: at the end of 6 weeks of treatment, and at 3 and 6 months post-treatment. The Headache Impact Test (HIT-6) is a questionnaire for measuring the impact of headache. A total of six questions are completed by the patient. They focus on daily activities such as work, education, home situation and leisure time. The HIT-6 gives a general overview of the impact of headache, including pain intensity, impairment and other items. Each of the six questions of the HIT-6 receives a score from 6-13. The final HIT-6 score can range from 36 to 78. A higher score indicates more disability due to headache.
Time frame: Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment
Scores for Symptoms of Post-traumatic Stress on the PTSD Checklist-5 (PCL-5)
Post-traumatic stress scores will be assessed over time. The PTSD Checklist for DSM-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. Respondents are asked to rate how bothered they have been by each of 20 items in the past month on a 5- point. Likert scale ranging from 0-4. Items are summed to provide a total severity score (range = 0-80). A higher score indicates more PTSD. 0 = Not at all 1 = A little bit 2 = Moderately 3 = Quite a bit 4 = Extremely
Time frame: Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment
| Milestone | Behavioral Headache Therapy | Cognitive Processing Therapy | Treatment as Usual |
|---|---|---|---|
| Started | 65 | 64 | 64 |
| Completed | 55 | 48 | 57 |
| Not completed | 10 | 16 | 7 |
| Withdrew: Did not receive treatment after randomization | 10 | 16 | 7 |
| Milestone | Behavioral Headache Therapy | Cognitive Processing Therapy | Treatment as Usual |
|---|---|---|---|
| Started | 55 | 48 | 57 |
| Completed 3-month follow-up | 31 | 21 | 40 |
| Completed 6-month follow-up | 32 | 23 | 40 |
| Completed post-treatment follow-up | 33 | 23 | 48 |
| Completed all follow-up | 23 | 21 | 36 |
| Included in analysis | 65 | 64 | 64 |
| Completed | 33 | 23 | 48 |
| Not completed | 22 | 25 | 9 |
| Withdrew: Withdrawn or lost to follow-up | 22 | 25 | 9 |
Baseline headache-related disability will be assessed over time based on headache-related disability scores on the HIT-6 obtained at multiple time points: at the end of 6 weeks of treatment, and at 3 and 6 months post-treatment. The Headache Impact Test (HIT-6) is a questionnaire for measuring the impact of headache. A total of six questions are completed by the patient. They focus on daily activities such as work, education, home situation and leisure time. The HIT-6 gives a general overview of the impact of headache, including pain intensity, impairment and other items. Each of the six questions of the HIT-6 receives a score from 6-13. The final HIT-6 score can range from 36 to 78. A higher score indicates more disability due to headache.
| score on a scale | Behavioral Headache Therapy | Cognitive Processing Therapy | Treatment as Usual |
|---|---|---|---|
| Baseline | 66.1 ± 5.4 | 66.1 ± 5.1 | 65.2 ± 6.4 |
| Post-treatment | 61.9 ± 6.3 | 63.3 ± 6.9 | 64.2 ± 6.6 |
| 3-Month Follow-up | 61.3 ± 8.0 | 64.8 ± 7.2 | 64.1 ± 7.1 |
| 6-Month Follow-up | 60.9 ± 8.8 | 63.3 ± 7.1 | 64.1 ± 7.3 |
Post-traumatic stress scores will be assessed over time. The PTSD Checklist for DSM-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. Respondents are asked to rate how bothered they have been by each of 20 items in the past month on a 5- point. Likert scale ranging from 0-4. Items are summed to provide a total severity score (range = 0-80). A higher score indicates more PTSD. 0 = Not at all 1 = A little bit 2 = Moderately 3 = Quite a bit 4 = Extremely
| score on a scale | Behavioral Headache Therapy | Cognitive Processing Therapy | Treatment as Usual |
|---|---|---|---|
| Baseline | 47.7 ± 14.7 | 48.6 ± 14.6 | 49.0 ± 13.3 |
| Post-Treatment | 36.5 ± 19.7 | 30.0 ± 20.9 | 41.6 ± 17.1 |
| 3-Month Follow-up | 30.2 ± 18.2 | 29.9 ± 20.0 | 43.0 ± 16.5 |
| 6-Month Follow-up | 30.3 ± 20.0 | 32.9 ± 21.0 | 41.0 ± 16.1 |
Collected over Baseline to 6-month post-treatment follow-up for a total of approximately 7 months (+/- 2 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Behavioral Headache Therapy | 0/65 (0%) | 0/65 (0%) | 0/65 (0%) |
| Cognitive Processing Therapy | 0/64 (0%) | 0/64 (0%) | 2/64 (3.1%) |
| Treatment as Usual | 0/64 (0%) | 0/64 (0%) | 0/64 (0%) |
| Event | Behavioral Headache Therapy | Cognitive Processing Therapy | Treatment as Usual |
|---|---|---|---|
| HospitalizationPsychiatric disorders | 0/65 | 0/64 | 0/64 |
| Event | Behavioral Headache Therapy | Cognitive Processing Therapy | Treatment as Usual |
|---|---|---|---|
| Worsening PTSD symptomsPsychiatric disorders | 0/65 | 2/64 | 0/64 |
| Age, Continuous(years) | Behavioral Headache Therapy | Cognitive Processing Therapy | Treatment as Usual | Total |
|---|---|---|---|---|
| Mean | 39.7 ± 8.4 | 39.7 ± 8.4 | 39.7 ± 8.4 | 39.7 ± 8.4 |
| Sex: Female, Male(Participants) | Behavioral Headache Therapy | Cognitive Processing Therapy | Treatment as Usual | Total |
|---|---|---|---|---|
| Female | 9 | 6 | 10 | 25 |
| Male | 56 | 58 | 53 | 167 |
| Race/Ethnicity, Customized(Participants) | Behavioral Headache Therapy | Cognitive Processing Therapy | Treatment as Usual | Total |
|---|---|---|---|---|
| Ethnicity — Hispanic | 27 | 28 | 26 | 81 |
| Ethnicity — Non-Hispanic | 37 | 36 | 37 | 110 |
| Race(Participants) | Behavioral Headache Therapy | Cognitive Processing Therapy | Treatment as Usual | Total |
|---|---|---|---|---|
| American Indian | 0 | 1 | 4 | 5 |
| Asian | 2 | 1 | 4 | 7 |
| Black/African American | 7 | 14 | 13 | 34 |
| Native Hawaiian | 2 | 2 | 2 | 6 |
| White | 43 | 34 | 33 | 110 |
| Other | 11 | 11 | 7 | 29 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Data sharing as per CAP (Consortium to Alleviate PTSD) established protocol.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio