Treatment for Migraine and Mood (TEAM-M): A Randomized Controlled Trial of a Mindfulness-based Training Program
概览
- 阶段
- 不适用
- 干预措施
- MBCT-Telephone
- 疾病 / 适应症
- Migraine
- 发起方
- Amanda Shallcross
- 入组人数
- 145
- 试验地点
- 3
- 主要终点
- Percentage of Treatment Session Adherence
- 状态
- 进行中（未招募）
- 最后更新
- 11天前
概览
简要总结
The researchers propose a three-arm pilot study of Mindfulness-Based Cognitive Therapy (MBCT) delivered via telephone (MBCT-T), video (MBCT-V) or Enhanced Usual Care (EUC).
详细描述
This study aims to set the stage for a future definitive large-scale Phase III trial in patients with migraine and depressive symptoms. This pilot is aimed at evaluating the feasibility and acceptability of the Telephone and Video MBCT and EUC in people with migraine (defined by the International Classification of Headache Disorders - 3) and depressive symptoms (defined by empirical cut-offs on the Patient Health Questionnaire - 9).
研究者
Amanda Shallcross
Associate Professor of Medicine
The Cleveland Clinic
入排标准
入选标准
- •Currently meets ICHD-3 criteria for migraine using the American Migraine Prevalence and Prevention Diagnostic Module
- •Self-reported 4-20 headache days per month
- •Score between 5-19 on the PHQ-8
- •Ability to read and speak English
- •Capacity to consent
- •≥1 year of migraine
排除标准
- •Meeting ICHD-3 criteria for persistent headache attributed to traumatic injury to the head (post- traumatic headache) on the American Migraine Prevalence and Prevention Diagnostic Module
- •Changes in anti-depressant medication within 6 weeks of intake
- •Starting or changing a migraine preventive treatment (i.e., oral medication, injection, preventive medicine, neuromodulatory device) within 12 weeks of intake
- •Changes in acute migraine treatment started within 4 weeks of enrollment
- •Comorbid psychiatric illness or clinical features that would interfere with participant's ability to participate in or receive benefit from the MBCT-T intervention, including but not limited to: active suicidal ideation; current or recent history (in the last six months) of psychosis or mania; borderline, histrionic or narcissistic personality disorder; cognitive impairment; sensory disabilities;, discomfort participating in a group-based intervention, drug use
- •Prior history of engaging in formal mindfulness-based interventions including: MBSR, MBCT, Acceptance and Commitment therapy, Dialectical Behavior Therapy
- •Current daily meditation practice
- •Unwilling to maintain stable current acute or preventive medication dosages for study duration
- •Any condition that would prevent being a suitable candidate for the group intervention
- •Medication overuse headache with migraine treatment
研究组 & 干预措施
MBCT-Telephone
8 weekly classes delivered via telephone.
干预措施: MBCT-Telephone
MBCT-Video
8 weekly classes delivered via video.
干预措施: MBCT-Video
Enhanced Usual Care (EUC)
8 weekly online modules delivered via web portal.
干预措施: Enhanced Usual Care (EUC)
结局指标
主要结局
Percentage of Treatment Session Adherence
时间窗: Week 8
Treatment Session Adherence is a measure of treatment feasibility. This measure will be assessed through electronic monitoring of the attendance logs of each treatment session. The number of treatment sessions attended will be recorded. A treatment arm will be considered feasible if participants attended/read 75% of sessions on average.
Client Satisfaction Questionnaire - 8 (CSQ-8)
时间窗: Week 8
The CSQ-8 assesses treatment acceptability. The CSQ-8 is an 8-item self-report measure designed to assess satisfaction with mental health services. Response options are coded on a 4-point scale and summed to produce a total score ranging from 8-32. The measure has consistently demonstrated excellent reliability and validity, and is commonly used in behavioral treatment trials. For the purposes of this study, a CSQ-8 score \> 24 is considered acceptable.
次要结局
- Change in Migraine-Specific Quality of Life Questionnaire v 2.1 (MSQ)(Month 0 to Month 3)
- Change in Quick Inventory of Depressive Symptomatology - Self-Report 16 (QIDS-SR16)(Month 0 to Month 3)
- Change in Headache Disability Inventory (HDI)(Month 0 to Month 3)