Multisite Advancement of Research on Chronic Posttraumatic Headache

NCT05620719 | Recruiting DMC

• 1 other identifier: HSC20220592H
• Study Type: interventional
• Target: 525
• Locations: 1 country
• Sites: 8

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

Conditions

Posttraumatic Headache

Keywords

Cognitive Behavioral Therapy; Telehealth; Veterans; Military Service Members; Chronic Pain; Headaches

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Standardized Headache Diary

  Baseline to 3-month follow-up

• Change in Patient Health Questionnaire-9

  Baseline to 3-month follow-up

• Change in Generalized Anxiety Disorder Screener-7

  Baseline to 3-month follow-up

• Change in PTSD Checklist-5

  Baseline to 3-month follow-up

Study Arms (3)

Clinic-based Cognitive Behavioral Therapy (CCBT)

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavioral Therapy for Posttraumatic Headache

Telemedicine-based Cognitive Behavioral Therapy (TCBT)

ACTIVE COMPARATOR

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.

Other: Telemedicine-based Cognitive Behavioral Therapy (TCBT)

Treatment As Usual

ACTIVE COMPARATOR

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.

Other: Treatment as Usual

Interventions

Cognitive Behavioral Therapy for Posttraumatic Headache BEHAVIORAL

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.

Also known as: CCBT

Clinic-based Cognitive Behavioral Therapy (CCBT)

Treatment as Usual OTHER

Participants will continue to engage in medical care as usual for 8 weeks.

Also known as: TAU or TPU

Treatment As Usual

Telemedicine-based Cognitive Behavioral Therapy (TCBT) OTHER

Participants assigned to TCBT will receive 8 sessions of cognitive behavioral therapy using telemedicine rather than face-to face office visits.

Telemedicine-based Cognitive Behavioral Therapy (TCBT)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (8)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

RECRUITING

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

RECRUITING

Tripler Army Medical Center (Desmond Doss Health Clinic, Schofield Barracks)

Honolulu, Hawaii, 96819, United States

RECRUITING

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

WITHDRAWN

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417, United States

RECRUITING

Carl R. Darnall Army Medical Center (Fort Cavazos)

Killeen, Texas, 76544, United States

RECRUITING

South Texas Veterans Health Care System

San Antonio, Texas, 78229, United States

RECRUITING

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

RECRUITING

Related Publications (19)

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  PMID: 31341715 BACKGROUND

• 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.

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• 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.

  PMID: 27084376 BACKGROUND

• 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.

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• 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.

  PMID: 14651415 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 20633738 BACKGROUND

• 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.

  PMID: 16788394 BACKGROUND

• 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.

  PMID: 18388841 BACKGROUND

• 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.

  PMID: 22303839 BACKGROUND

• 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.

  PMID: 23017210 BACKGROUND

• 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.

  PMID: 33490706 BACKGROUND

• 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.

  PMID: 30506568 BACKGROUND

• 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.

  PMID: 28860853 BACKGROUND

• 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.

  PMID: 17257236 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 20553333 BACKGROUND

MeSH Terms

Conditions

Post-Traumatic Headache; Chronic Pain; Headache

Interventions

Cognitive Behavioral Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Donald D McGeary, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole A Brackins, MS

CONTACT

210-450-8076; brackins@uthscsa.edu

Fermin A Carrizales

CONTACT

210-562-6724; carrizalesF@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Independent evaluators will complete posttreatment and follow-up assessments with each participant. They will instruct participants not to share which treatment group they were assigned. The Principle Investigator will remain blind to treatment randomization outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 17, 2022
• Study Start: August 24, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)