Neurofibromatosis 1 Clinical Trial
Official title:
Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing
The aims of this study are to compare the effect and durability of two stress and symptom management programs tailored for patients with neurofibromatosis on quality of life and psychosocial functioning.
Status | Recruiting |
Enrollment | 224 |
Est. completion date | January 30, 2022 |
Est. primary completion date | January 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Has a diagnosis of NF1, NF2, or Schwannomatosis - 18 years of age or older - Is capable of completing and fully understanding the informed consent process, study procedures, and study assessments in English - At least 6th grade self-reported reading level - Self-reported difficulties coping with stress and NF-symptoms - Score of 6 or higher on Perceived Stress Scale 4-Item (PSS-4) Exclusion Criteria: - Has major medical comorbidity not NF related expected to worsen in the next 12 months - Recent (within past 3 months) change in antidepressant medication - Recent (within past 3 months) participation in cognitive behavioral therapy or relaxation therapy - Has significant mental health diagnosis requiring immediate treatment (e.g., bipolar disorder, psychotic disorder, active substance use dependence) - Unable or unwilling to complete assessments electronically via REDCap - Unable or unwilling to participate in group videoconferencing sessions |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Physical 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 | |
Primary | Change in Psychological 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 | |
Secondary | Social 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 | |
Secondary | Environmental 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 | |
Secondary | Depression | Patient Health Questionnaire 9-Item (PHQ-9); 0-27; higher score indicates more symptoms of depression | 0 Weeks, 8 Weeks, 6 Months, 12 Months | |
Secondary | Anxiety | Generalized Anxiety Disorder 7-Item (GAD-7); 0-21; higher score indicates more symptoms of anxiety | 0 Weeks, 8 Weeks, 6 Months, 12 Months | |
Secondary | Social Support | Medical Outcome Study Social Support Survey (MOS); 18-90; higher scores indicate greater perceived social support | 0 Weeks, 8 Weeks, 6 Months, 12 Months | |
Secondary | Gratitude | Gratitude Questionnaire 6-Item (GQ-6); 6-42; higher scores indicate greater gratitude | 0 Weeks, 8 Weeks, 6 Months, 12 Months | |
Secondary | Optimism | Life Orientation Test-Revised (LOT-R); 0-40; higher scores indicate greater optimism | 0 Weeks, 8 Weeks, 6 Months, 12 Months | |
Secondary | Coping Strategies | Measure of Current Status Part A (MOCS-A); 0-52; higher scores indicate greater perceived ability to cope | 0 Weeks, 8 Weeks, 6 Months, 12 Months | |
Secondary | Mindfulness | Cognitive and Affective Mindfulness Scale (CAMS); 10-40; higher scores indicate greater mindfulness | 0 Weeks, 8 Weeks, 6 Months, 12 Months | |
Secondary | Empathy | Interpersonal Reactivity Index (IRI) Empathy Subscale; 7-Items; 0-28; higher scores indicate greater empathy | 0 Weeks, 8 Weeks, 6 Months, 12 Months | |
Secondary | Pain Intensity | Graded Chronic Pain Scale (GCPS); 0-100; higher scores indicate greater pain intensity | 0 Weeks, 8 Weeks, 6 Months, 12 Months | |
Secondary | Pain Interference | PROMIS Pain Interference; 8-40; higher scores indicate more pain interference | 0 Weeks, 8 Weeks, 6 Months, 12 Months | |
Secondary | Stress | Perceived Stress Scale 10-Item (PSS-10); 0-21; higher scores indicate greater levels of perceived stress | 0 Weeks, 8 Weeks, 6 Months, 12 Months |
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