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| Name | Class |
|---|---|
| Uniformed Services University of the Health Sciences | FED |
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The AMMO digital therapeutic (DTx) study will provide an online based program for participants with migraines after head injury to follow for 12 weeks. This study aims to see if using cognitive behavioral therapy aimed at military service members in an online self administered platform is effective therapy in the relief of migraines compared. The study will use a single blind online comparative program to test the effect.
The AMMO digital therapeutic (DTx) will be a novel intervention for PTH following concussive TBI, therefore this project is a pilot trial designed to test this new treatment. This pilot is a single-blind, randomized, controlled, interventional trial of current and former military personnel along with civilians with a history of concussive TBI and current PTH. The pilot trial will be conducted via online portal accessible by smartphone, tablet, or computer with remote interaction between participants and study staff. The pilot trial will include up to 100 participants randomized to either the active intervention or a comparison condition at a 1:1 ratio, and will provide preliminary data to determine the sample size of a future full clinical trial. Participants will complete a 12 week intervention period followed by a follow-up assessment 4 weeks after intervention is complete. Participants randomized to the comparison group will be provided access to the open label after end of 16 week follow-up.
In addition, updates to the DTx to improve usability and acceptability will be made if necessary based on feedback from the pilot trial, then applied to the final DTx used in a future, larger, clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | This arm will receive access to an online program that will guide them through cognitive behavioral therapy program. |
|
| Sham comparator | Sham Comparator | Participants will obtain access to an online program with activities not including the cognitive behavioral therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMMO PTH DTx | Device | An online cognitive behavioral therapy program accessed through a online program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-Item Headache Impact Testâ„¢ (HIT-6â„¢) | The HIT-6â„¢ is a brief standardized headache screening tool and questionnaire, derived from the original 54-item Headache Impact Test. It has been found to have good psychometric properties in assessing headache impact among patients in clinical practice and research (Bjorner, Kosinski, & Ware, 2003; Kosinski et al., 2003). | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the appropriate sample size for a future full clinical trial based on preliminary estimates of effect size for outcome measures | Use of Headache Impact Test and number of headache days per month to compare arms. This data will identify any changes to sample size in future studies. | 12 weeks |
| Post Traumatic Stress Disorder Checklist (DSM-5) |
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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 head trauma (ACRM, 1993) oAny period of loss of consciousness; oAny loss of memory for events immediately before or after the accident; oAny alteration in mental state at the time of the accident (e.g., feeling dazed, disoriented, or confused); and oFocal neurological deficit(s) that may or may not be transient oThe 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
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 headache following 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 severe impact (60-78) on functioning (Yang, Rendas-Baum, Varon, & Kosinski, 2011)
Be able to provide written, informed consent in English and follow study-related instructions
Have ownership of or reliable access to a smartphone with a data plan or internet connecting 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 head trauma (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
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 headache following 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 severe impact (60-78) on functioning (Yang, Rendas-Baum, Varon, & Kosinski, 2011)
Be able to provide written, informed consent in English and follow study-related instructions
Have ownership of or reliable access to a smartphone with a data plan or internet connecting capabilities
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 100% Remote Recruitment: Center for Neurscience and Regenerative Medicine | Bethesda | Maryland | 20817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29674307 | Background | Berry K, Salter A, Morris R, James S, Bucci S. Assessing Therapeutic Alliance in the Context of mHealth Interventions for Mental Health Problems: Development of the Mobile Agnew Relationship Measure (mARM) Questionnaire. J Med Internet Res. 2018 Apr 19;20(4):e90. doi: 10.2196/jmir.8252. | |
| 27287964 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 7, 2025 | Sep 16, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D051298 | Post-Traumatic Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| AMMO SHAM | Device | Online activities not including CBT in the AMMO online program. |
|
The PCL-5 is a self-report questionnaire designed to assess symptoms of PTSD (Blevins, Weathers, Davis, Witte, & Domino, 2015). The PCL-5 takes approximately 5-10 minutes to complete. |
| 16 weeks |
| Traumatic Brain Injury Quality of Life Scale (TBI-QOL) | The TBI-QOL is a self-report questionnaire composed of 22 item banks (Tulsky et al., 2016). It was developed to measure multiple domains of life for patients living with TBI, including physical, mental, cognitive, and social. The TBI-QOL takes approximately 30 minutes to complete. | 16 weeks |
| Patient Health Questionnaire-9 | The PHQ-9 is a self-report assessment for depressive symptoms (Kroenke, Spitzer, & Williams, 2001). Each item is scored on a scale of 0 to 3 providing a summary score that ranges from 0 to 27, with higher scores representing more severe depression. On the PHQ-9 a total score <5 is considered minimal depression, and scores of 5 to 9, 10 to 14, 15 to 19, and 20 to 27 are considered mild, moderate, moderately severe, and severe depression, respectively. | 16 weeks |
| Insomnia Severity Index (ISI) | The ISI is a self-report questionnaire designed to assess the presence and severity of primary insomnia sleep disorder and is empirically-validated in general and military populations (Bastien et al., 2001; Jenkins et al., 2015; Morin, Belleville, Belanger, & Ivers, 2011). | 16 weeks |
| User Version of the Mobile Application Rating Scale | Adapted from the Mobile Application Rating Scale (MARS), the uMARS is a 26-item self-report questionnaire designed to assess the quality, functionality, and aesthetics of a mobile application and its information (Stoyanov, Hides, Kavanagh, & Wilson, 2016). There is an additional open-text question for further comments on the users' opinions of the application. The uMARS takes approximately 15 minutes to complete. This measure will be optional for participants to complete. | 12 weeks |
| Mobile Agnew Relationship Measure | The mARM is an adaptation of a valid and reliable assessment of therapeutic alliance in face-to-face therapy (Berry, Salter, Morris, James, & Bucci, 2018). The 25-item questionnaire has been adjusted for use with digital health interventions, specifically for mental health. The mARM takes approximately 5 minutes to complete. | 12 weeks |
| User Program Feedback Questionnaire | Brief questionnaire utilizing Likert Scales related to gathering user feedback on personal experience with ease and accessibility of app utilization. | 12 weeks |
| Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and Validation of the User Version of the Mobile Application Rating Scale (uMARS). JMIR Mhealth Uhealth. 2016 Jun 10;4(2):e72. doi: 10.2196/mhealth.5849. |
| 21532953 | Background | Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601. |
| 26085301 | Background | Jenkins MM, Colvonen PJ, Norman SB, Afari N, Allard CB, Drummond SP. Prevalence and Mental Health Correlates of Insomnia in First-Encounter Veterans with and without Military Sexual Trauma. Sleep. 2015 Oct 1;38(10):1547-54. doi: 10.5665/sleep.5044. |
| 11438246 | Background | Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4. |
| 25931184 | Background | Tulsky DS, Kisala PA, Victorson D, Carlozzi N, Bushnik T, Sherer M, Choi SW, Heinemann AW, Chiaravalloti N, Sander AM, Englander J, Hanks R, Kolakowsky-Hayner S, Roth E, Gershon R, Rosenthal M, Cella D. TBI-QOL: Development and Calibration of Item Banks to Measure Patient Reported Outcomes Following Traumatic Brain Injury. J Head Trauma Rehabil. 2016 Jan-Feb;31(1):40-51. doi: 10.1097/HTR.0000000000000131. |
| 11556941 | 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. |
| 26606250 | Background | Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25. |
| 14651411 | Background | Kosinski M, Bjorner JB, Ware JE Jr, Batenhorst A, Cady RK. The responsiveness of headache impact scales scored using 'classical' and 'modern' psychometric methods: a re-analysis of three clinical trials. Qual Life Res. 2003 Dec;12(8):903-12. doi: 10.1023/a:1026111029376. |
| 14651417 | Background | Bjorner JB, Kosinski M, Ware JE Jr. Using item response theory to calibrate the Headache Impact Test (HIT) to the metric of traditional headache scales. Qual Life Res. 2003 Dec;12(8):981-1002. doi: 10.1023/a:1026123400242. |
| D009422 | Nervous System Diseases |