Multisite Advancement of Research on Chronic Posttraumatic Headache

Posttraumatic Headache Clinical Trial

Official title:

Project MARCH: Multisite Advancement of Research on Chronic Posttraumatic Headache

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05620719
• Other study ID #: HSC20220592H
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2023
• Est. completion date: August 2025

Study information

• Verified date: February 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Nicole A Brackins, MS
• Phone: 210-450-8076
• Email: brackins[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 3 VA medical centers and 4 military treatment facilities across the U.S. Participants will be assessed for headache-related disability, headache experience, and psychiatric comorbidities across multiple time points.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 525
• Est. completion date: August 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 A5.2.2.1 criterion for delayed-onset persistent headache attributable to mild 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.

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.

Related Conditions & MeSH terms

• Headache
• Post-Traumatic Headache
• Posttraumatic Headache

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Posttraumatic Headache
CBT for Posttraumatic Headaches consists of 8 sessions of cognitive behavioral therapy that focus on (1) discussions and exercises that increase awareness of what may be related to headaches, (2) relaxation techniques to manage physiological stress, and (3) problem-solving techniques to manage common stressors. Sessions are delivered weekly and can last between 45 to 75 minutes based on clinical content and patient response to the material.

Other:
• Treatment as Usual
Participants will continue to engage in medical care as usual for 8 weeks.
• Telemedicine-based Cognitive Behavioral Therapy (TCBT)
Participants assigned to TCBT will receive 8 sessions of cognitive behavioral therapy using telemedicine rather than face-to face office visits.

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Tripler Army Medical Center (Desmond Doss Health Clinic, Schofield Barracks)	Honolulu	Hawaii
United States	Carl R. Darnall Army Medical Center (Fort Cavazos)	Killeen	Texas
United States	Minneapolis VA Health Care System	Minneapolis	Minnesota
United States	VA Palo Alto Health Care System	Palo Alto	California
United States	Brooke Army Medical Center	San Antonio	Texas
United States	South Texas Veterans Health Care System	San Antonio	Texas

Sponsors (11)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Brooke Army Medical Center, C.R.Darnall Army Medical Center, Desmond Doss Health Clinic, Schofield Barracks, Harvard University, Minneapolis Veterans Affairs Medical Center, South Texas Veterans Health Care System, United States Department of Defense, University of California, Los Angeles, VA Palo Alto Health Care System, Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (19)

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Cameron IM, Crawford JR, Lawton K, Reid IC. Psychometric comparison of PHQ-9 and HADS for measuring depression severity in primary care. Br J Gen Pract. 2008 Jan;58(546):32-6. doi: 10.3399/bjgp08X263794. — View Citation

Dave A, Ganesh A, Adil MM, Tsao JW. Practice Current: How do you diagnose and treat post-concussive headache? Neurol Clin Pract. 2019 Jun;9(3):263-270. doi: 10.1212/CPJ.0000000000000656. — View Citation

Eckner JT, Seifert T, Pescovitz A, Zeiger M, Kutcher JS. Is Migraine Headache Associated With Concussion in Athletes? A Case-Control Study. Clin J Sport Med. 2017 May;27(3):266-270. doi: 10.1097/JSM.0000000000000346. — View Citation

Holtkamp MD, Grimes J, Ling G. Concussion in the Military: an Evidence-Base Review of mTBI in US Military Personnel Focused on Posttraumatic Headache. Curr Pain Headache Rep. 2016 Jun;20(6):37. doi: 10.1007/s11916-016-0572-x. — View Citation

Jaramillo CA, Eapen BC, McGeary CA, McGeary DD, Robinson J, Amuan M, Pugh MJ. A cohort study examining headaches among veterans of Iraq and Afghanistan wars: Associations with traumatic brain injury, PTSD, and depression. Headache. 2016 Mar;56(3):528-39. doi: 10.1111/head.12726. Epub 2015 Dec 21. — View Citation

Kosinski M, Bayliss MS, Bjorner JB, Ware JE Jr, Garber WH, Batenhorst A, Cady R, Dahlof CG, Dowson A, Tepper S. A six-item short-form survey for measuring headache impact: the HIT-6. Qual Life Res. 2003 Dec;12(8):963-74. doi: 10.1023/a:1026119331193. — View Citation

Kroenke K, Spitzer RL, Williams JB, Lowe B. The Patient Health Questionnaire Somatic, Anxiety, and Depressive Symptom Scales: a systematic review. Gen Hosp Psychiatry. 2010 Jul-Aug;32(4):345-59. doi: 10.1016/j.genhosppsych.2010.03.006. Epub 2010 May 7. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. — View Citation

Lew HL, Lin PH, Fuh JL, Wang SJ, Clark DJ, Walker WC. Characteristics and treatment of headache after traumatic brain injury: a focused review. Am J Phys Med Rehabil. 2006 Jul;85(7):619-27. doi: 10.1097/01.phm.0000223235.09931.c0. — View Citation

Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093. — View Citation

McGeary DD, McGeary CA, Gatchel RJ, Allison S, Hersh A. Assessment of research quality of telehealth trials in pain management: a meta-analysis. Pain Pract. 2013 Jun;13(5):422-31. doi: 10.1111/j.1533-2500.2012.00601.x. Epub 2012 Sep 27. — View Citation

McGeary DD, McGeary CA, Gatchel RJ. A comprehensive review of telehealth for pain management: where we are and the way ahead. Pain Pract. 2012 Sep;12(7):570-7. doi: 10.1111/j.1533-2500.2012.00534.x. Epub 2012 Feb 5. — View Citation

McGeary DD, Penzien DB, Resick PA, McGeary CA, Jaramillo CA, Eapen BC, Young-McCaughan S, Nabity PS, Moring JC, Houle TT, Keane TM, Peterson AL. Study design for a randomized clinical trial of cognitive-behavioral therapy for posttraumatic headache. Contemp Clin Trials Commun. 2021 Jan 6;21:100699. doi: 10.1016/j.conctc.2021.100699. eCollection 2021 Mar. — View Citation

Minen M, Jinich S, Vallespir Ellett G. Behavioral Therapies and Mind-Body Interventions for Posttraumatic Headache and Post-Concussive Symptoms: A Systematic Review. Headache. 2019 Feb;59(2):151-163. doi: 10.1111/head.13455. Epub 2018 Dec 1. — View Citation

Roper LS, Nightingale P, Su Z, Mitchell JL, Belli A, Sinclair AJ. Disability from posttraumatic headache is compounded by coexisting posttraumatic stress disorder. J Pain Res. 2017 Aug 21;10:1991-1996. doi: 10.2147/JPR.S129808. eCollection 2017. — View Citation

Schwedt TJ, Dodick DW, Hentz J, Trentman TL, Zimmerman RS. Occipital nerve stimulation for chronic headache--long-term safety and efficacy. Cephalalgia. 2007 Feb;27(2):153-7. doi: 10.1111/j.1468-2982.2007.01272.x. — View Citation

Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. — View Citation

Theeler BJ, Flynn FG, Erickson JC. Headaches after concussion in US soldiers returning from Iraq or Afghanistan. Headache. 2010 Sep;50(8):1262-72. doi: 10.1111/j.1526-4610.2010.01700.x. Epub 2010 Jun 10. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Headache Impact Test (HIT-6)	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.	Baseline to 3-month follow-up
Secondary	Change in Standardized Headache Diary	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).	Baseline to 3-month follow-up
Secondary	Change in Patient Health Questionnaire-9	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.	Baseline to 3-month follow-up
Secondary	Change in Generalized Anxiety Disorder Screener-7	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.	Baseline to 3-month follow-up
Secondary	Change in PTSD Checklist-5	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.	Baseline to 3-month follow-up