Telehealth Behavioral Migraine Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of TeleBMM
研究概览
简要总结
This project aims to develop the protocol and obtain feasibility and acceptability information for Telehealth Behavioral Migraine Management in a single-arm pre-post pilot study. The investigator and study team aim to recruit 20 people with migraine from the Montefiore Headache Center in the Bronx New York. Participants will receive the 12-week protocol including a mobile app headache diary, an online patient manual with interactive vignettes, 4 50-minute telehealth sessions, and 3 15-minute check-ins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician diagnosis of migraine
- •Current self-reported symptoms meeting the International Classification for Headache Disorders -- 3 criteria for migraine
- •Self-reported between 4 and 20 headache days/month
- •Aged 18-65
- •Can read English
- •Capacity to consent
排除标准
- •Psychiatric illness that would interfere with study participation
- •Meeting criteria for probable medication overuse headache
研究组 & 干预措施
Telehealth Behavioral Migraine Management
Participants will receive weekly online education sessions in the following categories: Relaxation, Early Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, Biofeedback, and Relapse Prevention. Participants will receive four monthly 50-minute telehealth sessions with a doctoral psychology student in a clinical health psychology program covering these topics, and three check-ins to enhance adherence to behavior change strategies. Participants will complete a daily headache diary throughout the course of treatment.
干预措施: Telehealth Behavioral Migraine Management (Behavioral)
Education Modules
Participants will receive eight online weekly educational modules about migraine that will take you approximately 15 minutes to complete in the following categories: Relaxation, Early Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, \Biofeedback, and Relapse Prevention. Participants will complete a daily headache diary throughout the course of treatment.
干预措施: Education Modules (Behavioral)
结局指标
主要结局
Feasibility of TeleBMM
时间窗: Week 0 through Week 12
Feasibility of the study will be based on patient adherence to the protocol. The number of treatment components participants complete (out of 20) will be tabulated. It is hypothesized that at least half of the participants will attend all four study sessions and complete all three self-guided modules. Dropouts will be included in the analysis. Results will be summarized using basic descriptive statistics.
Acceptability - Patient-Rated Satisfaction
时间窗: Post-treatment survey at Week 12
Patient-rated satisfaction (acceptability) with the program will be based on responses to the overall satisfaction question on a satisfaction survey. Participants are asked to rate overall satisfaction with the Telehealth Behavioral Management Program on a Likert-type scale ranging from 0 ("Not at all satisfied") to 4 ("Very satisfied"). Acceptability was to have been evaluated both on completers and assuming that individuals who dropped out were not satisfied (i.e., "Not at all satisfied").
次要结局
- Change in Quality of Life (Migraine Specific)(Change from Pre-treatment (Week 0) to Post-treatment (Week 12))
- Change in Headache Frequency(Change from Week 0 to Week 12)