Single-Blind, Randomized, Controlled Pilot Trial of a Cognitive-Behavioral Therapy Digital Therapeutic Delivered Online for Post-Traumatic Headaches in Adults With History of Concussive Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- 6-Item Headache Impact Test™ (HIT-6™)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Head trauma resulting in concussive TBI can be due to blast or non-blast mechanisms
- •Head trauma resulting in concussive TBI can have occurred any time in the participant'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 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):
- •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., feeling dazed, 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-blast mechanisms
- •Head trauma resulting in concussive TBI can have occurred any time in the participant'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 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
排除标准
- •They experienced a moderate or severe TBI
- •Their secondary headache is better accounted for by the ICHD-3 diagnosis of 8.2 medication-overuse headache; must meet diagnostic criteria for at least 1 medication-overuse headache diagnosis (8.2.1-8.2.8)
- •They are currently engaged in psychotherapeutic treatment or have engaged in psychotherapeutic treatment within 8 weeks prior to trial enrollment (for more information regarding recent treatment in potential participants, see section '3.2 Study 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 may adversely affect patient safety, participation, or scientific validity of the data being 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)
研究组 & 干预措施
Active
This arm will receive access to an online program that will guide them through cognitive behavioral therapy program.
干预措施: AMMO PTH DTx (Device)
Sham comparator
Participants will obtain access to an online program with activities not including the cognitive behavioral therapy
干预措施: AMMO SHAM (Device)
结局指标
主要结局
6-Item Headache Impact Test™ (HIT-6™)
时间窗: 16 weeks
The HIT-6™ 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).
次要结局
- Determine the appropriate sample size for a future full clinical trial based on preliminary estimates of effect size for outcome measures(12 weeks)
- Post Traumatic Stress Disorder Checklist (DSM-5)(16 weeks)
- Traumatic Brain Injury Quality of Life Scale (TBI-QOL)(16 weeks)
- Patient Health Questionnaire-9(16 weeks)
- Insomnia Severity Index (ISI)(16 weeks)
- User Version of the Mobile Application Rating Scale(12 weeks)
- Mobile Agnew Relationship Measure(12 weeks)
- User Program Feedback Questionnaire(12 weeks)