Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Penn Acoustic Neuroma Quality-of Life Scale (PANQOL)
研究概览
简要总结
The aim of this study is to determine, whether the 3RP is feasible, accepted and efficacious and durable when delivered via Skype to patients with neurofibromatosis type 2 (NF2) who are deaf or have severe hearing loss using Communication Access Realtime Translation (CART) and/or American Sign Language (ASL).
This will be a substudy of the IRB-approved protocol #2013P002605. It is the same study except it is looking at a particular sub-population: patients with NF2 who are hard of hearing.
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
- •Age 18 or older
- •Can read and speak English at or above the 6th grade level
- •Patients with NF2 who are deaf or have severe hearing loss.
排除标准
- •Severe active or untreated major mental illness that would interfere with study participation, to be determined at the discretion of the study investigator (e.g. untreated psychosis or suicidality)
- •Recent (within past 3 months) change in antidepressant medication
- •Use of formal relaxation training (including past participation in a mind-body program), currently or in the past 6 months.
- •Unable or unwilling to sign the informed consent documents
- •Unable or unwilling to complete psychological assessments online via the REDCap system.
- •Unable or unwilling to participate in an intervention delivered via videoconferencing with Skype.
- •Unwilling to use either CART or ASL for communication during the Skype groups.
研究组 & 干预措施
Stress Management Group 1
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
干预措施: Stress Management Group 1 (Behavioral)
Stress Management Group 2
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
干预措施: Stress Management Group 2 (Behavioral)
结局指标
主要结局
Penn Acoustic Neuroma Quality-of Life Scale (PANQOL)
时间窗: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32 and week 64)
The PANQOL measures quality of life specifically for patients with NF2.
Quality of Life (WHOQOL-BREF)
时间窗: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32 and week 64)
The WHOQOL-BREF comprises of 26 items which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.
次要结局
- Cognitive and Affective Mindfulness Scale (CAMS)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- The 14-Item Resiliency Scale (RS-14)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Perceived Stress Scale (PSS-10)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- The Gratitude Questionnaire (GQ-6)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Medical Outcomes Study (MOS) Social Support Survey(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Measure of Current Status (MOCS-A)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Patient Health Questionnaire (PHQ)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Life Orientation Test (LOT) Optimism Scale(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
研究者
Ana-Maria Vranceanu, PhD
Clinical Psychologist
Massachusetts General Hospital