Resiliency Training in Adolescents With NF1 and NF2; A Randomized Controlled Trial Via Secure Live Video Conferencing to Improve Emotional, Social and Physical Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 2
- 主要终点
- Change in Physical Health Quality of Life
研究概览
简要总结
This randomized controlled trial for resiliency training in adolescents with Neurofibromatosis 1 and Neurofibromatosis 2 via secure live video to determine the efficacy two stress and symptom management programs. Both programs are 8 week group programs.
详细描述
Neurofibromatosis (NFs) are rare genetic conditions with cure. Adolescents with NF experience more symptoms of depression and anxiety, higher levels of stress associated with coping with NF symptoms, lower levels of self esteem, difficulties with social skills and social support, high rates of learning disabilities, and more pain as compared with the general population norms.
The aims of this study are to compare the effect of two stress and symptom management programs tailored for adolescents 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, 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
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has a diagnosis of NF1 or NF2 and is between the ages of 12-17
- •Is capable of completing and fully understanding the informed consent process/assent and the study procedures and assessments in English; has parental approval for participation
- •English speaking and at least a 3rd grade self-reported and parent reported reading level
- •Self reported/parent reported difficulties coping with stress and NF symptoms
排除标准
- •Has major medical co-morbidity not NF related expected to worsen in the next 12 months
- •Recent (within past 3 months) change in antidepressant medication
- •Recent participation in cognitive behavioral therapy or relaxation therapy (within past 3 months)
- •Has significant mental health diagnosis requiring immediate treatment (e.g., untreated bipolar disorder, psychotic disorder, active substance dependence)
- •Unable or unwilling to complete assessments electronically via REDCap
- •Unable or unwilling to participate in group videoconferencing sessions
- •Unable or unwilling to participate along with at least 1 parent in a video screening session
研究组 & 干预措施
Stress and Symptom Management Program 1
干预措施: Stress and Symptom Management Program 1 (Behavioral)
Stress and Symptom Management 2
干预措施: Stress and Symptom Management Program 2 (Behavioral)
结局指标
主要结局
Change in Physical Health 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 Health 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
- Environmental Quality of Life(0 weeks, 8 weeks, 6 months, 12 months)
- Social relationships Quality of Life(0 weeks, 8 weeks, 6 months,12 months)
- Depression(0 weeks, 8 weeks, 6 months, 12 months)
- Anxiety(0 weeks, 8 weeks, 6 months, 12 months)
- Pain intensity(0 weeks, 8 weeks, 6 months, 12 months)
- Pain interference(0 weeks, 8 weeks, 6 months, 12 months)
研究者
Ana-Maria Vranceanu, PhD
Principle Investigator
Massachusetts General Hospital