Digital Phenotyping to Monitor a CBT Pain Prevention Intervention for Women With Chronic Life Stress Undergoing Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Numeric Pain Rating
研究概览
简要总结
This study investigates a Cognitive Behavioral Therapy (CBT) intervention for women who are undergoing elective surgery. The objective is to provide a toolkit of stress management techniques to decrease pain and opioid use following surgery.
详细描述
The Investigators are doing this research to understand whether a pre-surgery virtual cognitive behavioral therapy (CBT) group intervention combined with an activity tracker can reduce pain and opioid use in women with chronic stress undergoing elective spine surgery.
Participants will be randomly divided in two groups and one of the groups will be invited to attend four weekly virtual CBT group sessions designed to improve reactions to stress, increase motivation for physical activity, develop tools for managing pain, and utilize mindfulness techniques. Two optional sessions will be available following surgery. Individuals randomized to usual care will not attend the online sessions but will continue to wear the activity tracker to provide information about their physical activity as well as the use of an App to track their pain and medication use.
The ultimate goal of this research is to enhance stress management and coping skills to help patients better manage pain after surgery and reduce their need for opioid medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Female Gender
- •Patients own a compatible smartphone (iPhone or Android) or tablet and can download the Fitbit app on their device
- •Planned elective spine surgery
排除标准
- •Cognitive impairment (judged to interfere with study participation)
- •Male gender
- •Non-English speaking
- •Pain conditions requiring urgent surgery
- •A diagnosis of cancer
- •A present psychiatric condition (e.g. DSM diagnosis of schizophrenia, delusional disorder, psychotic disorder or dissociative disorder) that would be judged to interfere with the study
- •Visual impairment or motor impairment that would interfere with study participation
结局指标
主要结局
Numeric Pain Rating
时间窗: At Baseline and weekly until 90 days.
Research Subjects will be asked to rate their pain on a scale from 0-10.
次要结局
- Activity Tracking (Digital Phenotyping)(At Baseline and weekly until 90 days.)
- Pain Medication Usage(At Baseline and weekly until 90 days.)
研究者
Linda S Aglio
Anesthesiologist, Associate Professor
Brigham and Women's Hospital