Neurofibromatoses
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALStress and Symptom Management Program 1
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.
BEHAVIORALStress and Symptom Management Program 2
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.
Sponsors
Massachusetts General Hospital
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Health Quality of Life | 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 | 0 weeks, 8 weeks, 6 months,12 months | World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social relationships Quality of Life | 0 weeks, 8 weeks, 6 months,12 months | World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL |
| Environmental Quality of Life | 0 weeks, 8 weeks, 6 months, 12 months | World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL |
| Depression | 0 weeks, 8 weeks, 6 months, 12 months | Patient Health Questionnaire (PHQ-9) Adolescent Version; 0-27; Higher score indicates more symptoms of depression |
| Anxiety | 0 weeks, 8 weeks, 6 months, 12 months | Generalized Anxiety Disorder (GAD-7) Questionnaire; 0-21; Higher score indicates more symptoms of anxiety |
| Pain intensity | 0 weeks, 8 weeks, 6 months, 12 months | Numerical Rating Scale; 0-10; Higher score indicates more intense pain. |
| Pain interference | 0 weeks, 8 weeks, 6 months, 12 months | Pain Interference Index (PII); 0-36; Higher score indicates more pain interference |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAna-Maria Vranceanu, PhD
Massachusetts General Hospital
Outcome results
None listed