Post-traumatic Headache, PTSD
Conditions
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 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.
Interventions
BEHAVIORALBehavioral Headache Therapy
A standard, manualized behavioral intervention for primary headache disorders
BEHAVIORALCognitive Processing Therapy
A gold-standard treatment for PTSD, called Cognitive Processing Therapy
BEHAVIORALTreatment as Usual
Treatment as usual, receiving standard care for PTHA
Sponsors
Wake Forest University
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* adult (ages 18 - 70 years old) * U.S. military Veterans with military service during Operations Enduring Freedom (OEF), Iraqi Freedom (OIF), and New Dawn (OND) * have sustained a traumatic head injury * have been diagnosed or report symptoms consistent with chronic (\> 3 months) posttraumatic headache attributed to a traumatic injury sustained as part of military service. We are focusing on chronic PTHA due to the very low likelihood of headache remission after 3 months, the disability associated with chronic PTHA, and the high prevalence of chronic versus acute PTHA in this Veteran population. A positive PTHA diagnosis will be indicated for individuals with de novo headache onset within 3 months of a concussion or exacerbation of pre-existing headache symptoms (increased frequency, duration, or intensity) within 3 months of traumatic injury. This is consistent with the existing ICHD-III criteria for PTHA inclusion will be based on either a pre-existing diagnosis of chronic PTHA documented in the Veteran's medical record by a PRC/PSC provider or a Neurologist (e.g., ICD-10 code G44.329) or through screening with one of our PRC/PSC co-PIs if the Veteran reports symptoms consistent with chronic PTHA but has never had it documented in her/his medical record. * Participants taking headache medication with a stable pattern of use for the prior 6 week period (including no prescribed changes in medical regimen). * Participants must have some posttraumatic stress (PTS) symptoms based on a cut-off score of at least 25 or above on the PTSD CheckList -Version (PCL-5), which all participants will complete as part of their screening. * Participants must also report on the Clinician Administered PTSD Scale (CAPS-5) an exposure to a traumatic event (Criterion A), at least one intrusion symptom (Criterion B), and at least one avoidance symptom (Criterion C). There is some evidence suggesting 40% comorbidity between PTSD and new onset headache, so it is reasonable to assume that at least half of all PTHA participants recruited for this study will have PTHA and comorbid PTS symptoms. The inclusion of PTS symptoms in this sample is vital based on reports indicating that PTS symptoms and PTSD actually increase vulnerability to PTHA and chronic headache in military populations
Exclusion criteria
* there has been a recent and significant change in the nature of headache symptoms over the last 6 weeks prior to their screening (as determined by the investigators) * Participants currently in CPT or prolonged exposure for PTSD. * Participant has medication overuse headache as defined by the Structured Diagnostic Headache Interview-Revised (Brief Version; SDIHR). * the participant is unable to read or speak English at a 6th grade level * they have had a psychiatric hospitalization in the last 12 months * they currently meet a psychiatric diagnosis of substance abuse \[based on Alcohol Use Disorders Identification Test (AUDIT) assessment during screening\] * they are pregnant or plan to become pregnant during the trial (due to concerns about pregnancy-induced headache that may obscure findings) * if a psychiatric problem is present that warrants immediate treatment based upon clinical judgment * if they demonstrate significant cognitive impairment that could impact treatment adherence/benefit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache-related Disability Scores on the Headache Impact Test 6 (HIT-6) | Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment | 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. |
| Scores for Symptoms of Post-traumatic Stress on the PTSD Checklist-5 (PCL-5) | Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment | 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 |
Countries
United States
Participant flow
Pre-assignment details
Subjects who were consented and randomized, but did not continue to therapy
Participants by arm
| Arm | Count |
|---|---|
| Behavioral Headache Therapy A standard, manualized behavioral intervention for primary headache disorders
Behavioral Headache Therapy: A standard, manualized behavioral intervention for primary headache disorders | 65 |
| Cognitive Processing Therapy A gold-standard treatment for PTSD, called Cognitive Processing Therapy
Cognitive Processing Therapy: A gold-standard treatment for PTSD, called Cognitive Processing Therapy | 64 |
| Treatment as Usual Treatment as usual, receiving standard care for PTHA
Treatment as Usual: Treatment as usual, receiving standard care for PTHA | 64 |
| Total | 193 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Consent and Randomization | Did not receive treatment after randomization | 10 | 16 | 7 |
| Randomization and Treatment | Withdrawn or lost to follow-up | 22 | 25 | 9 |
Baseline characteristics
| Characteristic | Behavioral Headache Therapy | Cognitive Processing Therapy | Treatment as Usual | Total |
|---|---|---|---|---|
| Age, Continuous | 39.7 years STANDARD_DEVIATION 8.4 | 39.7 years STANDARD_DEVIATION 8.4 | 39.7 years STANDARD_DEVIATION 8.4 | 39.7 years STANDARD_DEVIATION 8.4 |
| Race American Indian | 0 Participants | 1 Participants | 4 Participants | 5 Participants |
| Race Asian | 2 Participants | 1 Participants | 4 Participants | 7 Participants |
| Race Black/African American | 7 Participants | 14 Participants | 13 Participants | 34 Participants |
| Race Native Hawaiian | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Race Other | 11 Participants | 11 Participants | 7 Participants | 29 Participants |
| Race White | 43 Participants | 34 Participants | 33 Participants | 110 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic | 27 Participants | 28 Participants | 26 Participants | 81 Participants |
| Race/Ethnicity, Customized Ethnicity Non-Hispanic | 37 Participants | 36 Participants | 37 Participants | 110 Participants |
| Sex: Female, Male Female | 9 Participants | 6 Participants | 10 Participants | 25 Participants |
| Sex: Female, Male Male | 56 Participants | 58 Participants | 53 Participants | 167 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 64 | 0 / 64 |
| other Total, other adverse events | 0 / 65 | 2 / 64 | 0 / 64 |
| serious Total, serious adverse events | 0 / 65 | 0 / 64 | 0 / 64 |
Outcome results
Primary
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
Population: Intent-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Headache Therapy | Headache-related Disability Scores on the Headache Impact Test 6 (HIT-6) | Baseline | 66.1 score on a scale | Standard Deviation 5.4 |
| Behavioral Headache Therapy | Headache-related Disability Scores on the Headache Impact Test 6 (HIT-6) | Post-treatment | 61.9 score on a scale | Standard Deviation 6.3 |
| Behavioral Headache Therapy | Headache-related Disability Scores on the Headache Impact Test 6 (HIT-6) | 3-Month Follow-up | 61.3 score on a scale | Standard Deviation 8 |
| Behavioral Headache Therapy | Headache-related Disability Scores on the Headache Impact Test 6 (HIT-6) | 6-Month Follow-up | 60.9 score on a scale | Standard Deviation 8.8 |
| Cognitive Processing Therapy | Headache-related Disability Scores on the Headache Impact Test 6 (HIT-6) | 6-Month Follow-up | 63.3 score on a scale | Standard Deviation 7.1 |
| Cognitive Processing Therapy | Headache-related Disability Scores on the Headache Impact Test 6 (HIT-6) | Baseline | 66.1 score on a scale | Standard Deviation 5.1 |
| Cognitive Processing Therapy | Headache-related Disability Scores on the Headache Impact Test 6 (HIT-6) | 3-Month Follow-up | 64.8 score on a scale | Standard Deviation 7.2 |
| Cognitive Processing Therapy | Headache-related Disability Scores on the Headache Impact Test 6 (HIT-6) | Post-treatment | 63.3 score on a scale | Standard Deviation 6.9 |
| Treatment as Usual | Headache-related Disability Scores on the Headache Impact Test 6 (HIT-6) | 6-Month Follow-up | 64.1 score on a scale | Standard Deviation 7.3 |
| Treatment as Usual | Headache-related Disability Scores on the Headache Impact Test 6 (HIT-6) | Post-treatment | 64.2 score on a scale | Standard Deviation 6.6 |
| Treatment as Usual | Headache-related Disability Scores on the Headache Impact Test 6 (HIT-6) | 3-Month Follow-up | 64.1 score on a scale | Standard Deviation 7.1 |
| Treatment as Usual | Headache-related Disability Scores on the Headache Impact Test 6 (HIT-6) | Baseline | 65.2 score on a scale | Standard Deviation 6.4 |
Comparison: Sample size based on 2-tailed specified joint superiority testing of 2 primary outcomes at α = .025 and power of 0.80 to detect an effect size (d) of 0.52 for both primary outcomes (representing a clinically significant change of 2.8 points on the HIT-6). The primary analysis set was intention to treat (ITT). multiple imputation accounted for missing data in ITT. Missing outcome scores at posttreatment, 3-month, and 6-month follow-ups were multiply imputed (m = 100) using multilevel models.p-value: <0.00195% CI: [-5.4, -1.4]Mixed Models Analysis
Comparison: See previous section for powerp-value: 0.2195% CI: [-3.7, 0.8]Mixed Models Analysis
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Headache Therapy | Scores for Symptoms of Post-traumatic Stress on the PTSD Checklist-5 (PCL-5) | Baseline | 47.7 score on a scale | Standard Deviation 14.7 |
| Behavioral Headache Therapy | Scores for Symptoms of Post-traumatic Stress on the PTSD Checklist-5 (PCL-5) | Post-Treatment | 36.5 score on a scale | Standard Deviation 19.7 |
| Behavioral Headache Therapy | Scores for Symptoms of Post-traumatic Stress on the PTSD Checklist-5 (PCL-5) | 3-Month Follow-up | 30.2 score on a scale | Standard Deviation 18.2 |
| Behavioral Headache Therapy | Scores for Symptoms of Post-traumatic Stress on the PTSD Checklist-5 (PCL-5) | 6-Month Follow-up | 30.3 score on a scale | Standard Deviation 20 |
| Cognitive Processing Therapy | Scores for Symptoms of Post-traumatic Stress on the PTSD Checklist-5 (PCL-5) | 6-Month Follow-up | 32.9 score on a scale | Standard Deviation 21 |
| Cognitive Processing Therapy | Scores for Symptoms of Post-traumatic Stress on the PTSD Checklist-5 (PCL-5) | Baseline | 48.6 score on a scale | Standard Deviation 14.6 |
| Cognitive Processing Therapy | Scores for Symptoms of Post-traumatic Stress on the PTSD Checklist-5 (PCL-5) | 3-Month Follow-up | 29.9 score on a scale | Standard Deviation 20 |
| Cognitive Processing Therapy | Scores for Symptoms of Post-traumatic Stress on the PTSD Checklist-5 (PCL-5) | Post-Treatment | 30.0 score on a scale | Standard Deviation 20.9 |
| Treatment as Usual | Scores for Symptoms of Post-traumatic Stress on the PTSD Checklist-5 (PCL-5) | 6-Month Follow-up | 41.0 score on a scale | Standard Deviation 16.1 |
| Treatment as Usual | Scores for Symptoms of Post-traumatic Stress on the PTSD Checklist-5 (PCL-5) | Post-Treatment | 41.6 score on a scale | Standard Deviation 17.1 |
| Treatment as Usual | Scores for Symptoms of Post-traumatic Stress on the PTSD Checklist-5 (PCL-5) | 3-Month Follow-up | 43.0 score on a scale | Standard Deviation 16.5 |
| Treatment as Usual | Scores for Symptoms of Post-traumatic Stress on the PTSD Checklist-5 (PCL-5) | Baseline | 49.0 score on a scale | Standard Deviation 13.3 |
Comparison: Same sample size calculation as HIT-6 analyses, powered to detect a difference of 8.2 points on the PCL-5 total score.p-value: 0.0495% CI: [-12.7, -0.3]Mixed Models Analysis
Comparison: See above.p-value: 0.0195% CI: [-15.9, -1.9]Mixed Models Analysis