E-CBT DTx for Post Traumatic Headaches in Adults with History of TBI

Inclusion Criteria:

• Be aged ≥ 18 to ≤ 70 years

• Have a history of concussive TBI ≥ 3 months prior to enrollment:

• A concussive TBI is defined by having at least one of the following after a headtrauma (ACRM, 1993) oAny period of loss of consciousness; oAny loss of memory forevents immediately before or after the accident; oAny alteration in mental state atthe time of the accident (e.g., feeling dazed, disoriented, or confused); and oFocalneurological deficit(s) that may or may not be transient oThe injury must not exceedany of the following (ACRM, 1993):

• Loss of consciousness of approximately 30 minutes or less;

• After 30 minutes an initial GCS score of 13-15; and

• PTA not greater than 24 hours

• Head trauma resulting in concussive TBI can be due to blast or non-blastmechanisms

• Head trauma resulting in concussive TBI can have occurred any time in theparticipant's life: prior to military service, during deployment, in garrison,or after leaving military service

• Have a history of chronic PTH defined as: o Headache is reported to have developed (or worsened) after one of the following*:

• The injury to the head;

• Regaining of consciousness following the injury to the head; or

• Discontinuation of medication(s) impairing ability to sense or report headachefollowing the injury to the head

• Not better accounted for by another ICHD-3 diagnosis** o The headache persists for >3 months after its onset (ICHD, 2013)

• Have a HIT-6™ score of ≥ 56 to 78 indicative of substantial impact (56-59) or severeimpact (60-78) on functioning (Yang, Rendas-Baum, Varon, & Kosinski, 2011)

• Be able to provide written, informed consent in English and follow study-relatedinstructions

• Have ownership of or reliable access to a smartphone with a data plan or internetconnecting capabilities

• Be aged ≥ 18 to ≤ 70 years

• Have a history of concussive TBI ≥ 3 months prior to enrollment:

• A concussive TBI is defined by having at least one of the following after a headtrauma (ACRM, 1993):

• Any period of loss of consciousness;

• Any loss of memory for events immediately before or after the accident;

• Any alteration in mental state at the time of the accident (e.g., feelingdazed, disoriented, or confused); and

• Focal neurological deficit(s) that may or may not be transient

• The injury must not exceed any of the following (ACRM, 1993):

• Loss of consciousness of approximately 30 minutes or less;

• After 30 minutes an initial GCS score of 13-15; and

• PTA not greater than 24 hours

• Head trauma resulting in concussive TBI can be due to blast or non-blastmechanisms

• Head trauma resulting in concussive TBI can have occurred any time in theparticipant's life: prior to military service, during deployment, in garrison,or after leaving military service

• Have a history of chronic PTH defined as: o Headache is reported to have developed (or worsened) after one of the following*:

• The injury to the head;

• Regaining of consciousness following the injury to the head; or

• Discontinuation of medication(s) impairing ability to sense or report headachefollowing the injury to the head

• Not better accounted for by another ICHD-3 diagnosis** o The headache persists for >3 months after its onset (ICHD, 2013)

• Have a HIT-6™ score of ≥ 56 to 78 indicative of substantial impact (56-59) or severeimpact (60-78) on functioning (Yang, Rendas-Baum, Varon, & Kosinski, 2011)

• Be able to provide written, informed consent in English and follow study-relatedinstructions

• Have ownership of or reliable access to a smartphone with a data plan or internetconnecting capabilities

Exclusion Criteria:

• They experienced a moderate or severe TBI

• Their secondary headache is better accounted for by the ICHD-3 diagnosis of 8.2medication-overuse headache; must meet diagnostic criteria for at least 1medication-overuse headache diagnosis (8.2.1-8.2.8)

• They are currently engaged in psychotherapeutic treatment or have engaged inpsychotherapeutic treatment within 8 weeks prior to trial enrollment (for moreinformation regarding recent treatment in potential participants, see section '3.2Study Procedures,' sub-section 'Baseline Evaluation')

• They report change or discontinuation of headache prophylaxis in the past 4 weeks

• They report active psychotic or bipolar symptoms

• In the opinion of the investigator, they have other considerations that mayadversely affect patient safety, participation, or scientific validity of the databeing collected (including, but not limited to, active plan or intent for suicide,visual impairment, hand dysfunction or amputation, substantial cognitive impairment,life expectancy of less than 6 months)