Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing

Study Overview
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Brief Summary
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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
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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.

Official Title
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Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing

Conditions
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Neurofibromatoses, Neurofibromatosis 1, Neurofibromatosis 2, Schwannomatosis

Intervention / Treatment
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* Behavioral: Stress and Symptom Management Program 1
* Behavioral: Stress and Symptom Management Program 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress and Symptom Management Program 1<br>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. | Behavioral: Stress and Symptom Management Program 1<br>* 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.<br>* Other names: SMP2;|
| Experimental: Stress and Symptom Management Program 2<br>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. | Behavioral: Stress and Symptom Management Program 2<br>* 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.<br>* Other names: SMP2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Gratitude | Gratitude Questionnaire 6-Item (GQ-6); 6-42; higher scores indicate greater gratitude | 0 Weeks, 8 Weeks, 6 Months, 12 Months | 
| Optimism | Life Orientation Test-Revised (LOT-R); 0-40; higher scores indicate greater optimism | 0 Weeks, 8 Weeks, 6 Months, 12 Months | 
| 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 | 
| Mindfulness | Cognitive and Affective Mindfulness Scale (CAMS); 10-40; higher scores indicate greater mindfulness | 0 Weeks, 8 Weeks, 6 Months, 12 Months | 
| Empathy | Interpersonal Reactivity Index (IRI) Empathy Subscale; 7-Items; 0-28; higher scores indicate greater empathy | 0 Weeks, 8 Weeks, 6 Months, 12 Months | 
| Pain Intensity | Graded Chronic Pain Scale (GCPS); 0-100; higher scores indicate greater pain intensity | 0 Weeks, 8 Weeks, 6 Months, 12 Months | 
| Pain Interference | PROMIS Pain Interference; 8-40; higher scores indicate more pain interference | 0 Weeks, 8 Weeks, 6 Months, 12 Months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychiatry, Psychology, Psychosocial, Behavioral