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Multisite Advancement of Research on Chronic Posttraumatic Headache

Primary Purpose

Posttraumatic Headache

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Posttraumatic Headache
Treatment as Usual
Telemedicine-based Cognitive Behavioral Therapy (TCBT)
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Headache focused on measuring Cognitive Behavioral Therapy, Telehealth, Veterans, Military Service Members, Chronic Pain, Headaches

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Any veteran or active duty service member (age 18 to 70 years) with mTBI 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 were they can receive reminders and complete the on-line Sleep Diaries. To participate in telemedicine study arm, participants must: Have access to high-speed internet or 4G/5G phone service and be able to connect from a location that affords privacy. Have phone or computer equipment to run the virtual video connect platform OR be willing to use study-provided equipment for the duration of the study. 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 is unable to read or speak English at a 6th grade level. 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.

Sites / Locations

  • South Texas Veterans Health Care SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Clinic-based Cognitive Behavioral Therapy (CCBT)

Telemedicine-based Cognitive Behavioral Therapy (TCBT)

Treatment As Usual

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
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.

Full Information

First Posted
November 1, 2022
Last Updated
August 29, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Brooke Army Medical Center, C.R.Darnall Army Medical Center, Desmond Doss Health Clinic, Schofield Barracks, Minneapolis Veterans Affairs Medical Center, South Texas Veterans Health Care System, VA Palo Alto Health Care System, Walter Reed National Military Medical Center, Harvard University, University of California, Los Angeles, United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT05620719
Brief Title
Multisite Advancement of Research on Chronic Posttraumatic Headache
Official Title
Project MARCH: Multisite Advancement of Research on Chronic Posttraumatic Headache
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Brooke Army Medical Center, C.R.Darnall Army Medical Center, Desmond Doss Health Clinic, Schofield Barracks, Minneapolis Veterans Affairs Medical Center, South Texas Veterans Health Care System, VA Palo Alto Health Care System, Walter Reed National Military Medical Center, Harvard University, University of California, Los Angeles, United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Headache
Keywords
Cognitive Behavioral Therapy, Telehealth, Veterans, Military Service Members, Chronic Pain, Headaches

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
525 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinic-based Cognitive Behavioral Therapy (CCBT)
Arm Type
Active Comparator
Arm Description
CCBT provides CBT for posttraumatic headache through 8 face-to-face, in-clinic sessions.
Arm Title
Telemedicine-based Cognitive Behavioral Therapy (TCBT)
Arm Type
Active Comparator
Arm 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.
Arm Title
Treatment As Usual
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Posttraumatic Headache
Other Intervention Name(s)
CCBT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Other Intervention Name(s)
TAU or TPU
Intervention Description
Participants will continue to engage in medical care as usual for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Telemedicine-based Cognitive Behavioral Therapy (TCBT)
Intervention Description
Participants assigned to TCBT will receive 8 sessions of cognitive behavioral therapy using telemedicine rather than face-to face office visits.
Primary Outcome Measure Information:
Title
Change in Headache Impact Test (HIT-6)
Description
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.
Time Frame
Baseline to 3-month follow-up
Secondary Outcome Measure Information:
Title
Change in Standardized Headache Diary
Description
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).
Time Frame
Baseline to 3-month follow-up
Title
Change in Patient Health Questionnaire-9
Description
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.
Time Frame
Baseline to 3-month follow-up
Title
Change in Generalized Anxiety Disorder Screener-7
Description
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.
Time Frame
Baseline to 3-month follow-up
Title
Change in PTSD Checklist-5
Description
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.
Time Frame
Baseline to 3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any veteran or active duty service member (age 18 to 70 years) with mTBI 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 were they can receive reminders and complete the on-line Sleep Diaries. To participate in telemedicine study arm, participants must: Have access to high-speed internet or 4G/5G phone service and be able to connect from a location that affords privacy. Have phone or computer equipment to run the virtual video connect platform OR be willing to use study-provided equipment for the duration of the study. 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 is unable to read or speak English at a 6th grade level. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole A Brackins, MS
Phone
210-450-8076
Email
brackins@uthscsa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Fermin A Carrizales
Phone
210-562-6724
Email
carrizalesF@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald D McGeary, PhD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Texas Veterans Health Care System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Carrizales
Email
carrizalesf@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Rebecca Tapia, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27929328
Citation
Arcaya MC, Lowe SR, Asad AL, Subramanian SV, Waters MC, Rhodes J. Association of posttraumatic stress disorder symptoms with migraine and headache after a natural disaster. Health Psychol. 2017 May;36(5):411-418. doi: 10.1037/hea0000433. Epub 2016 Dec 8.
Results Reference
background
PubMed Identifier
18186994
Citation
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.
Results Reference
background
PubMed Identifier
31341715
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.
Results Reference
background
PubMed Identifier
27428679
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.
Results Reference
background
PubMed Identifier
27084376
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.
Results Reference
background
PubMed Identifier
26688427
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.
Results Reference
background
PubMed Identifier
14651415
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.
Results Reference
background
PubMed Identifier
11556941
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.
Results Reference
background
PubMed Identifier
20633738
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.
Results Reference
background
PubMed Identifier
16788394
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.
Results Reference
background
PubMed Identifier
18388841
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.
Results Reference
background
PubMed Identifier
22303839
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.
Results Reference
background
PubMed Identifier
23017210
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.
Results Reference
background
PubMed Identifier
33490706
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.
Results Reference
background
PubMed Identifier
30506568
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.
Results Reference
background
PubMed Identifier
28860853
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.
Results Reference
background
PubMed Identifier
17257236
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.
Results Reference
background
PubMed Identifier
16717171
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.
Results Reference
background
PubMed Identifier
20553333
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.
Results Reference
background

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Multisite Advancement of Research on Chronic Posttraumatic Headache

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