Study design for a randomized clinical trial of cognitive-behavioral therapy for posttraumatic headache.
Donald D McGeary, Donald B Penzien, Patricia A Resick, Cindy A McGeary, Carlos A Jaramillo, Blessen C Eapen, Stacey Young-McCaughan, Paul S Nabity, John C Moring, Timothy T Houle and 2 more
Article in Contemporary clinical trials communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05620719 (Project MARCH), which is not on this map. Cited by 3 papers.
0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.7field-weighted citation impact, top 17% of its field
1 · What the graph read from it
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
2 · The registry
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
NCT05620719 narecruitingnot on this mapstarted 2023, after this paper: background citation
Project MARCH: Multisite Advancement of Research on Chronic Posttraumatic Headache
TypeinterventionalSponsorThe University of Texas Health Science Center at San AntonioRan2023 to 2027Enrolled525ConditionsPosttraumatic HeadacheArmsCognitive Behavioral Therapy for Posttraumatic Headache, Treatment as Usual, Telemedicine-based Cognitive Behavioral Therapy (TCBT)
3 · Its place in the literature
Who cites it
3 citing papers in PubMed, 14 citations in OpenAlex.
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
5 · Who and what money
Authors and funding
12 authors at 7 institutions in 1 country.
Donald D McGearyDepartment of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center San Antonio, San Antonio, TX, USA.
Donald B PenzienDepartments of Psychiatry and Behavioral Medicine & Neurology, Wake Forest University, Winston-Salem, NC, USA.
Patricia A ResickDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.
Cindy A McGearyDepartment of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center San Antonio, San Antonio, TX, USA.
Carlos A JaramilloSouth Texas Veterans Health Care System, San Antonio, TX, USA.
Blessen C EapenGreater Los Angeles Veterans Health Care System, Los Angeles, CA, USA.
Stacey Young-McCaughanDepartment of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center San Antonio, San Antonio, TX, USA.
Paul S NabityDepartment of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center San Antonio, San Antonio, TX, USA.
John C MoringDepartment of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center San Antonio, San Antonio, TX, USA.
Timothy T HouleDepartment of Anaesthesia, Massachusetts General Hospital, Boston, MA, USA.
Terence M KeaneNational Center for PTSD, VA Boston Healthcare System, Boston, MA, USA.
Alan L PetersonDepartment of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center San Antonio, San Antonio, TX, USA.
The University of Texas Health Science Center at San Antonio · USSouth Texas Veterans Health Care System · USDuke University Hospital · USMassachusetts General Hospital · USNational Center for PTSD · USVA Greater Los Angeles Healthcare System · USWake Forest University · US
Funding
No grant is acknowledged in the PubMed record.
6 · The paper itself
Abstract
Posttraumatic headache (PTH) is a common debilitating condition arising from head injury and is highly prevalent among military service members and veterans with traumatic brain injury (TBI). Diagnosis and treatment for PTH is still evolving, and surprisingly little is known about the putative mechanisms that drive these headaches. This manuscript describes the design of a randomized clinical trial of two nonpharmacological (i.e., behavioral) interventions for posttraumatic headache. Design of this trial required careful consideration of PTH diagnosis and inclusion criteria, which was challenging due to the lack of standard clinical characteristics in PTH unique from other types of headaches. The treatments under study differed in clinical focus and dose (i.e., number of treatment sessions), but the trial was designed to balance the treatments as well as possible. Finally, while the primary endpoints for pain research can vary from assessments of pain intensity to objective and subjective functional measures, this trial of PTH interventions chose carefully to establish clinically relevant endpoints and to maximize the opportunity to detect significant differences between groups with two primary outcomes. All these issues are discussed in this manuscript.
Indexed as
AUDIT, Alcohol Use Disorders Identification Test-Self ReportB-IPF, Brief Inventory of Psychosocial FunctioningCAP, Consortium to Alleviate PTSDCAPS-5, Clinician-Administered PTSD Scale for DSM-5CBT, cognitive-behavioral therapyCCBT, clinic-based cognitive-behavioral therapy intervention for headacheCEQ, Credibility and Expectancy QuestionnaireCGRP, calcitonin gene-related peptideCPRS, Computerized Patient Record SystemCPT, Cognitive Processing TherapyCRIS, Community Reintegration of Injured Service MembersDoD, U.S. Department of DefenseDRRI-2-D, Deployment Risk and Resilience Inventory-2-Deployment EnvironmentDRRI-2-P, Deployment Risk and Resilience Inventory-Postbattle ExperiencesDSI-SS, Depressive Symptom Index-Suicide SubscaleGAD-7, Generalized Anxiety Disorder ScreenerGLM, general linear mixedHeadacheHIPAA, Health Insurance Portability and Accountability ActHIT-6, Headache Impact TestHMSE, Headache Management Self-Efficacy ScaleHSLC, Headache-Specific Locus of Control ScaleICHD-2, International Classification of Headache Disorders, 2nd EditionICHD-3, International Classification of Headache Disorders, 3rd EditionIRB, institutional review boardISI, Insomnia Severity IndexITT, intent to treatLEC-5, Life Events Checklist for DSM-5NIH, National Institutes of HealthNSI, Neurobehavioral Symptom InventoryOSU TBI-ID-SF, Ohio State University TBI Identification Method-Interview FormPCL-5, PTSD Checklist for DSM-5PHQ-15, Patient Health Questionnaire-15PHQ-9, Patient Health Questionnaire-9 ItemPolymorbidityPP, per protocolPRC, Polytrauma Rehabilitation CenterPROMIS, Patient-Reported Outcomes Measurement Information SystemPTCI, Posttraumatic Cognitions InventoryPTHA Study, posttraumatic headache and PTSD studyPTH, posttraumatic headachePTSDPTSD, posttraumatic stress disorderQDS, Quick Drinking ScreenRSES, Response to Stressful Experiences ScaleSDIH-R, Structured Diagnostic Interview for Headache-Revised, Brief VersionSITBI, Self-Injurious Thoughts and Behaviors Interview – Short FormSTOP, Snoring, Tired, Observed, Blood PressureTAU, treatment as usualTBI, traumatic brain injuryTraumatic brain injuryVA, U.S. Department of Veterans AffairsVeteransVHCS, Veterans Health Care SystemVR-12, Veterans RAND 12-Item Health Survey
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.
Study design for a randomized clinical trial of cognitive-behavioral therapy for posttraumatic headache. · full record | Socratic