Multisite Advancement of Research on Chronic Posttraumatic Headache

The University of Texas System (UT)

Status: Enrolling

Conditions: Posttraumatic Headache

Treatments: Behavioral: Cognitive Behavioral Therapy for Posttraumatic Headache; Other: Treatment as Usual; Other: Telemedicine-based Cognitive Behavioral Therapy (TCBT)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05620719

HSC20220592H

Details and patient eligibility

About

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.

*VA Palo Alto Health Care System is temporarily randomizing into TAU and TCBT only.

Full 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.

Enrollment: 525 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 or study physician clinical judgement confirms stability; 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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525 participants in 3 patient groups

Clinic-based Cognitive Behavioral Therapy (CCBT)

Active Comparator group

Description:

CCBT provides CBT for posttraumatic headache through 8 face-to-face, in-clinic sessions.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Posttraumatic Headache

Telemedicine-based Cognitive Behavioral Therapy (TCBT)

Active Comparator group

Description:

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:

Other: Telemedicine-based Cognitive Behavioral Therapy (TCBT)

Treatment As Usual

Active Comparator group

Description:

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.

Treatment:

Other: Treatment as Usual