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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stress and Symptom Management Program 1 | Experimental |
| |
| Stress and Symptom Management 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stress and Symptom Management Program 1 | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Health Quality of Life | World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL | 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 | 0 weeks, 8 weeks, 6 months,12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Social relationships Quality of Life | World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL | 0 weeks, 8 weeks, 6 months,12 months |
| Environmental Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana-Maria Vranceanu, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02140 | United States |
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| ID | Term |
|---|---|
| D017253 | Neurofibromatoses |
| ID | Term |
|---|---|
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
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| Stress and Symptom Management Program 2 | Behavioral | 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. |
|
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL
| 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 | 0 weeks, 8 weeks, 6 months, 12 months |
| Anxiety | Generalized Anxiety Disorder (GAD-7) Questionnaire; 0-21; Higher score indicates more symptoms of anxiety | 0 weeks, 8 weeks, 6 months, 12 months |
| Pain intensity | Numerical Rating Scale; 0-10; Higher score indicates more intense pain. | 0 weeks, 8 weeks, 6 months, 12 months |
| Pain interference | Pain Interference Index (PII); 0-36; Higher score indicates more pain interference | 0 weeks, 8 weeks, 6 months, 12 months |
| D009369 | Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D020752 | Neurocutaneous Syndromes |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |