Neurofibromatoses, Neurofibromatosis 1, Neurofibromatosis 2, Schwannomatosis
Conditions
Keywords
Psychiatry, Psychology, Psychosocial, Behavioral
Brief summary
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.
Detailed description
The aims of this study are to compare the effect of two stress and symptom management programs tailored for patients 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, anxiety, distress, mindfulness, gratitude, social support, empathy, optimism, coping, pain intensity and pain interference.
Interventions
BEHAVIORALStress and Symptom Management Program 1
The Stress and Symptom Management Program 1 (SMP1) introduces and reinforces stress and symptom management skills. The program consists of 8 weekly sessions (90 minutes each), delivered through live videoconferencing.
BEHAVIORALStress and Symptom Management Program 2
The Stress and Symptom Management Program 2 (SMP2) introduces and reinforces stress and symptom management skills. The program consists of 8 weekly sessions (90 minutes each), delivered through live videoconferencing.
Sponsors
United States Department of Defense
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical 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 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 |
|---|---|---|
| Depression | 0 Weeks, 8 Weeks, 6 Months, 12 Months | Patient Health Questionnaire 9-Item (PHQ-9); 0-27; higher score indicates more symptoms of depression |
| Anxiety | 0 Weeks, 8 Weeks, 6 Months, 12 Months | Generalized Anxiety Disorder 7-Item (GAD-7); 0-21; higher score indicates more symptoms of anxiety |
| Social Support | 0 Weeks, 8 Weeks, 6 Months, 12 Months | Medical Outcome Study Social Support Survey (MOS); 18-90; higher scores indicate greater perceived social support |
| Gratitude | 0 Weeks, 8 Weeks, 6 Months, 12 Months | Gratitude Questionnaire 6-Item (GQ-6); 6-42; higher scores indicate greater gratitude |
| Optimism | 0 Weeks, 8 Weeks, 6 Months, 12 Months | Life Orientation Test-Revised (LOT-R); 0-40; higher scores indicate greater optimism |
| Social 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 |
| Mindfulness | 0 Weeks, 8 Weeks, 6 Months, 12 Months | Cognitive and Affective Mindfulness Scale (CAMS); 10-40; higher scores indicate greater mindfulness |
| Empathy | 0 Weeks, 8 Weeks, 6 Months, 12 Months | Interpersonal Reactivity Index (IRI) Empathy Subscale; 7-Items; 0-28; higher scores indicate greater empathy |
| Pain Intensity | 0 Weeks, 8 Weeks, 6 Months, 12 Months | Graded Chronic Pain Scale (GCPS); 0-100; higher scores indicate greater pain intensity |
| Pain Interference | 0 Weeks, 8 Weeks, 6 Months, 12 Months | PROMIS Pain Interference; 8-40; higher scores indicate more pain interference |
| Stress | 0 Weeks, 8 Weeks, 6 Months, 12 Months | Perceived Stress Scale 10-Item (PSS-10); 0-21; higher scores indicate greater levels of perceived stress |
| Coping Strategies | 0 Weeks, 8 Weeks, 6 Months, 12 Months | Measure of Current Status Part A (MOCS-A); 0-52; higher scores indicate greater perceived ability to cope |
| 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 |
Countries
United States
Outcome results
None listed