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
- 65
- 试验地点
- 2
- 主要终点
- Quality of Life (WHOQOL-BREF)
研究概览
简要总结
This study tests the efficacy of an 8-week, Skype-based, group resiliency training intervention (The Relaxation Response Resiliency Program) for improving psychological stress in patients with Neurofibromatosis. A control group will receive a general health education curriculum. The investigators hypothesize that patients will improve on measures of psychological stress as a result of the resiliency program.
A substudy (Unique Protocol ID: 2013P002605b) has been approved to test this study on a 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
- Supportive Care
- 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
- •Diagnosis of neurofibromatosis type 1, neurofibromatosis type 2, or schwannomatosis
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.
结局指标
主要结局
Quality of Life (WHOQOL-BREF)
时间窗: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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.
Satisfaction with Life (SWL)
时间窗: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
The Satisfaction with Life (SWL) scale is a reliable and valid 5-item self-report measure of global life satisfaction. Responses are made on a 7-point scale with higher scores reflecting higher life satisfaction.
次要结局
- Patient Health Quesionnaire (PHQ)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- The Pain Catastrophizing Scale (PCS)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Cognitive and Affective Mindfulness Scale (CAMS)(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))
- Interpersonal Reactivity Index (IRI)(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))
- The Gratitude Questionnaire (GQ-6)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Functional Assessment of Chronic Illness Therapy- Fatigue Scale (FACIT-Fatigue)(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))
- The 14-Item Resiliency Scale (RS-14)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Pain Numerical Rating Scale (Pain NRS)(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))
- Functional Assessment of Chronic Illness Therapy- Spirituality Scale (FACIT-Sp)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Brief Pain Inventory (BPI)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Posttraumatic Growth Inventory (PGI)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Distress Analogue Scales(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32). Also administered at mid-interevention, before each group session.)
- Epworth Sleepiness Scale (ESS)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
研究者
Ana-Maria Vranceanu, PhD
Dr.
Massachusetts General Hospital