Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 2
- 主要终点
- Change in Physical Quality of Life
研究概览
简要总结
The aims of this study are to compare the effect and durability of two stress and symptom management programs tailored for patients with neurofibromatosis on quality of life and psychosocial functioning.
详细描述
The aims of this study are to compare the effect of two stress and symptom management programs tailored for patients with neurofibromatosis on quality of life and psychosocial functioning. We will also examine the degree to which treatment-dependent improvements in quality of life are mediated by improvements in depression, anxiety, distress, mindfulness, gratitude, social support, empathy, optimism, coping, pain intensity and pain interference.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a diagnosis of NF1, NF2, or Schwannomatosis
- •18 years of age or older
- •Is capable of completing and fully understanding the informed consent process, study procedures, and study assessments in English
- •At least 6th grade self-reported reading level
- •Self-reported difficulties coping with stress and NF-symptoms
- •Score of 6 or higher on Perceived Stress Scale 4-Item (PSS-4)
排除标准
- •Has major medical comorbidity not NF related expected to worsen in the next 12 months
- •Recent (within past 3 months) change in antidepressant medication
- •Recent (within past 3 months) participation in cognitive behavioral therapy or relaxation therapy
- •Has significant mental health diagnosis requiring immediate treatment (e.g., bipolar disorder, psychotic disorder, active substance use dependence)
- •Unable or unwilling to complete assessments electronically via REDCap
- •Unable or unwilling to participate in group videoconferencing sessions
结局指标
主要结局
Change in Physical Quality of Life
时间窗: 0 Weeks, 8 Weeks, 6 Months, 12 Months
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL
Change in Psychological Quality of Life
时间窗: 0 Weeks, 8 Weeks, 6 Months, 12 Months
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL
次要结局
- Pain Interference(0 Weeks, 8 Weeks, 6 Months, 12 Months)
- Stress(0 Weeks, 8 Weeks, 6 Months, 12 Months)
- Social Quality of Life(0 Weeks, 8 Weeks, 6 Months, 12 Months)
- Environmental Quality of Life(0 Weeks, 8 Weeks, 6 Months, 12 Months)
- Depression(0 Weeks, 8 Weeks, 6 Months, 12 Months)
- Coping Strategies(0 Weeks, 8 Weeks, 6 Months, 12 Months)
- Mindfulness(0 Weeks, 8 Weeks, 6 Months, 12 Months)
- Empathy(0 Weeks, 8 Weeks, 6 Months, 12 Months)
- Anxiety(0 Weeks, 8 Weeks, 6 Months, 12 Months)
- Gratitude(0 Weeks, 8 Weeks, 6 Months, 12 Months)
- Optimism(0 Weeks, 8 Weeks, 6 Months, 12 Months)
- Social Support(0 Weeks, 8 Weeks, 6 Months, 12 Months)
- Pain Intensity(0 Weeks, 8 Weeks, 6 Months, 12 Months)
研究者
Ana-Maria Vranceanu, PhD
Clinical Psychologist
Massachusetts General Hospital