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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
200
The Stress and Symptom Management Program 1 introduces and reinforces stress and symptom management for adolescents with NF. The program consists of 8 weekly 45 minute sessions, delivered through videoconferencing.
The Stress and Symptom Management Program 2 introduces and reinforces stress and symptom management for adolescents with NF. The program consists of 8 weekly 45 minute sessions, delivered through videoconferencing.
Massachusetts General Hospital
Boston, Massachusetts, United States
Change in Physical Health Quality of Life
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL
Time frame: 0 weeks, 8 weeks, 6 months,12 months
Change in Psychological Health Quality of Life
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL
Time frame: 0 weeks, 8 weeks, 6 months,12 months
Social relationships Quality of Life
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL
Time frame: 0 weeks, 8 weeks, 6 months,12 months
Environmental Quality of Life
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL
Time frame: 0 weeks, 8 weeks, 6 months, 12 months
Depression
Patient Health Questionnaire (PHQ-9) Adolescent Version; 0-27; Higher score indicates more symptoms of depression
Time frame: 0 weeks, 8 weeks, 6 months, 12 months
Anxiety
Generalized Anxiety Disorder (GAD-7) Questionnaire; 0-21; Higher score indicates more symptoms of anxiety
Time frame: 0 weeks, 8 weeks, 6 months, 12 months
Pain intensity
Numerical Rating Scale; 0-10; Higher score indicates more intense pain.
Time frame: 0 weeks, 8 weeks, 6 months, 12 months
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Pain interference
Pain Interference Index (PII); 0-36; Higher score indicates more pain interference
Time frame: 0 weeks, 8 weeks, 6 months, 12 months