Multisite Advancement of Research on Chronic Posttraumatic Headache
- Conditions
- Posttraumatic Headache
- Interventions
- Other: Telemedicine-based Cognitive Behavioral Therapy (TCBT)Other: Treatment as UsualBehavioral: Cognitive Behavioral Therapy for Posttraumatic Headache
- Registration Number
- NCT05620719
- Brief Summary
Posttraumatic headache (PTH) is a common and highly disabling consequence of traumatic brain injury (TBI) in U.S. military service members and veterans. Cognitive Behavioral Therapy for PTH has been shown to significantly improve disability outcomes in veterans with persistent PTH when delivered in-person. Telemedicine platforms can dramatically increase access to evidence-based care. However, whether CBT for PTH retains its effectiveness when delivered through a telemedicine platform has yet to be established. The purpose of this 3-arm randomized clinical trial is to compare Clinic-based Cognitive-Behavioral Therapy (CCBT) to Telemedicine-based Cognitive Behavioral Therapy (TCBT) and to treatment as usual (TAU) in 525 service members and veterans with chronic posttraumatic headaches (PTH) at 4 VA medical centers and 3 military treatment facilities across the U.S. Participants will be assessed for headache-related disability, headache experience, and psychiatric comorbidities across multiple time points.
- Detailed Description
Posttraumatic headache (PTH) is noticeably more common among military service members and veterans than among civilians, with an estimated 80-90% of veterans with TBI reporting new or exacerbated headaches. Unlike civilian PTH, military and veteran PTH is likely to become chronic and recalcitrant to most front-line interventions for primary headache (e.g., migraine, tension-type). Service members and veterans with PTH report significantly decreased productivity in work and home activities and high rates of military discharge and work absenteeism. Pharmacological treatments for chronic PTH have proven problematic (i.e., unwanted side effects; worsening of symptoms long term). However, prior to 2019, guidance for non-pharmacological treatment approaches for PTH was unclear. In 2019, the investigators completed a single-site randomized clinical trial comparing Clinic-based CBT for PTH to Treatment at Usual in 193 veterans with PTH. The study found that Clinic-based CBT for PTH led to a significant improvement in headache-related disability (as measured by the 6-Item Headache Impact Test; HIT-6) at follow-up. In contrast, headache disability scores for participants in the Treatment as Usual condition remained unchanged.
COVID-19 pandemic led to widespread recognition of the need for distance-technology platforms to add meaningful infrastructure for extended service delivery without the limitations of in-office care. Telehealth-based care can decrease the cost and increase the convenience of treatment leading some to suggest that telehealth may eventually become a first option for treating patients. Given the potential impact of CBT for PTH to improve the functioning of service members and veterans with PTH following TBI, it is important to determine whether the results of the single-site trial can be replicated across diverse geographic regions and whether CBT for PTH retains its efficacy in improving headache-related disability when delivered through telemedicine platforms.
The study has four aims.
Aim 1: Determine the efficacy of Clinic-based Cognitive-Behavioral Therapy (CCBT; using our manualized intervention) and Telemedicine-Based Cognitive Behavioral Therapy (TCBT; using our manualized intervention) for posttraumatic headache (PTH) compared to treatment as usual (TAU) across seven geographically-dispersed treatment sites.
Hypothesis 1A: There will be significantly greater improvement in PTH disability (measured by the Headache Impact Test-6; HIT-6) at 3-month follow-up among service members and veterans in CCBT compared to TAU.
Hypothesis 1B: There will be significantly greater improvement in PTH disability (measured by the HIT-6) at 3-month follow-up for service members/veterans who participate in TCBT compared to TAU.
Aim 2: Establish the non-inferiority of TCBT to CCBT in the treatment of PTH-related disability. This second aim will be pursued if either CCBT or TCBT is superior to TAU in Aim 1.
Hypothesis 2: TCBT will be non-inferior to CCBT on headache-related disability (measured by the HIT-6) at 3-month follow-up.
Aim 3: Assess contribution of heterogeneity treatment effects on PTH treatment outcome. A patient-level model to assess heterogeneity treatment effect (HTE) based on site, system, and patient-level factors including all participants across sites will be run and the degree of benefit conditional on the model predictors using procedures from the Predictive Approaches to Treatment Effect Heterogeneity statement (PATH) will be assessed.
Hypothesis 3: A prognostic model consisting of baseline predictors will adequately predict disability risk with good precision and calibration. Individuals predicted to be at high risk of disability will exhibit differential treatment response, with less expected benefit than individuals with less risk.
Aim 4: Solicit participant perspectives on their treatment experience and identify patient-centered treatment targets that might better reflect their response to treatment.
Hypothesis 4A: Patients will identify measurable treatment targets across multiple domains.
Hypothesis 4B: Patients will provide treatment insights that might better reflect their response to treatment.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 525
- Any veteran or active duty service member (DEERS-eligible; age 18 to 70 years) with mild or moderate TBI whose headache began or exacerbated within 3 months of a head or neck injury.
- Headache meets ICHD-3 A5.2 criterion for delayed-onset persistent headache attributable to mild or moderate TBI and PTH is ongoing at enrollment (most recent headache within the past 2 weeks).
- At least moderate to severe headache-related disability based on a HIT-6 score greater than 50.
- Participant is stable on headache medication at baseline assessment (i.e., no changes in medication prescriptions in the past 4 weeks; this includes botulinum toxin injections and devices like Cefaly).
- Participant has a phone where they can receive reminders and complete the on-line Headache Diaries.
- Participant speaks and reads/understands English well enough to fully participate in the intervention and to reliably complete assessment measures.
- Participant reports a significant change in headache symptoms within 4 weeks of screening or has another secondary headache that may account for symptoms.
- Participant has medication overuse headache based on Structured Diagnostic Headache Interview-Revised (Brief Version; SDIH-R) and clinical judgment.
- Participant has a psychiatric problem that warrants immediate treatment as indicated in the electronic health record, flagged study during testing, or confirmed by a clinician through screening or review of clinical notes.
- Participant demonstrates significant cognitive impairment that could impact treatment adherence/benefit.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telemedicine-based Cognitive Behavioral Therapy (TCBT) Telemedicine-based Cognitive Behavioral Therapy (TCBT) TCBT provides 8-sessions of CBT for posttraumatic headache using telemedicine technology rather than attending in-office sessions. Additionally, TCBT includes instructions for each session specific to the mechanics of a telehealth encounter (e.g., asking participant for name, location, and accessible phone number for location in case of technical failure or crisis). All TCBT participants must be enrolled at the MTF or VA from which they were recruited, and the treatment facility will be notified that they are receiving TCBT in case a crisis arises and needs to be managed by the site. Treatment As Usual Treatment as Usual Participants will continue to engage in clinical care as usual for 8 weeks. Research staff will call the TAU participants weekly to assess for adverse events. Research staff at each site will be trained on standardized assessment of usual care activities using forms adapted from our single-site trial. Clinic-based Cognitive Behavioral Therapy (CCBT) Cognitive Behavioral Therapy for Posttraumatic Headache CCBT provides CBT for posttraumatic headache through 8 face-to-face, in-clinic sessions.
- Primary Outcome Measures
Name Time Method Change in Headache Impact Test (HIT-6) Baseline to 3-month follow-up Headache-disability as measured by the Headache Impact Test. The HIT-6 is a 6-item measure of headache-disability. The measure uses a 5-point Likert scale to rate the frequency that the respondent experiences headache-relate disability across six domains of functioning. Total scores range from 36 to 78 with higher scores representing a higher level of headache-relate disability.
- Secondary Outcome Measures
Name Time Method Change in Patient Health Questionnaire-9 Baseline to 3-month follow-up Total score on the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is 9-item, self-report screener for current depressive symptoms. Each item is rated on a frequency scale ranging from 0 (Not at all) to 3 (Nearly Every day). The measure provides a total severity score that ranges from 0 to 27, with higher scores representing more severe depressive symptoms.
Change in Generalized Anxiety Disorder Screener-7 Baseline to 3-month follow-up Total score on the Generalized Anxiety Disorder Screener (GAD-7): The GAD-7 is 7-item, self-report screener for current anxiety symptoms. Each item is rated on a frequency scale ranging from 0 (Not at all) to 3 (Nearly Every day). The measure provides a total severity score that ranges from 0 to 21, with higher scores representing more severe anxiety symptoms.
Change in PTSD Checklist-5 Baseline to 3-month follow-up Scale measurements by the PTSD CheckList-5 (PCL-5). The PCL-5 is a 20-item, self-report measure of PTSD symptoms experienced in the past month. Each item is rated on a severity scale ranging from 0 (Not at all) to 4 (Extremely). The measure provides a total severity score that ranges from 0 to 80, with higher scores representing more PTSD symptoms.
Change in Standardized Headache Diary Baseline to 3-month follow-up Headache frequency, duration and intensity will be assessed using a smartphone-based daily headache self-monitoring diary developed by the HCoE. During treatment, participants will record their headache intensity twice daily, using a 0 to 10 scale, to assess: (a) days per week with a headache (ranging from 0 to 7); (b) weekly headache frequency (range from 0 to 10); (c) headache duration (\>= 0 hours); and (d) average peak headache intensity (range from 0 to 10).
Trial Locations
- Locations (8)
VA Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
VA Palo Alto Health Care System
🇺🇸Palo Alto, California, United States
Tripler Army Medical Center (Desmond Doss Health Clinic, Schofield Barracks)
🇺🇸Honolulu, Hawaii, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
Minneapolis VA Health Care System
🇺🇸Minneapolis, Minnesota, United States
Carl R. Darnall Army Medical Center (Fort Cavazos)
🇺🇸Killeen, Texas, United States
South Texas Veterans Health Care System
🇺🇸San Antonio, Texas, United States
Brooke Army Medical Center
🇺🇸San Antonio, Texas, United States