NCT02387177已完成不适用
Resiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Quality of life (WHO-QOLBREFadol)
研究概览
简要总结
The aim of this research is to adapt the NF-specific adult version of the Skype 3RP for use with adolescents, and to test its feasibility, acceptability, and preliminary effect in improving quality of life, and in decreasing stress and psychological distress.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be between the ages of 12 and 17
- •Can read and speak English at or above the 6th grade level
- •Diagnosis of neurofibromatosis type 1 or neurofibromatosis type 2 by a specialized medical provider
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 participate in an intervention delivered via videoconferencing with Skype
研究组 & 干预措施
Stress Management Group 1
Experimental
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
Experimental
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
Quality of life (WHO-QOLBREFadol)
时间窗: Change between Baseline (week0), Post-intervention (Week8) and Follow Up (Week 36)
Measures quality of life
次要结局
- Generalized Anxiety Disorder 7-item (GAD-7) scale(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))
- Pain Interference Index (PII)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Measure of Current Status (MOCS) Part A(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- The Pain Catastrophizing Scale - Child Version (PCS-C)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Patient Health Questionnaire for Adolescents (PHQ-A)(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))
- Epworth Sleepiness Scale-Revised for Children (ESS)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Gratitude Questionnaire Six-Item Form (GQ-6)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Child and Adolescent Mindfulness Measure (CAMM)(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))
- Satisfaction with life adolescent(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being Scale (FACIT-Sp)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- MOS (Support/Empathy)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Quality of Life (WHOQOL-BREF)(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
研究点 (2)
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