Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing

Not Applicable

• Conditions: Neurofibromatosis 1; Schwannomatosis; Neurofibromatoses; Neurofibromatosis 2
• Interventions: Behavioral: Stress and Symptom Management Program 1; Behavioral: Stress and Symptom Management Program 2

• Registration Number: NCT03406208
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2018-01-19
• Study First Posted: 2018-01-23
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-08
• Primary Completion: 2022-01-30
• Study Completion: 2022-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stress and Symptom Management Program 1	Stress 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.
Stress and Symptom Management Program 2	Stress 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Pain Interference	0 Weeks, 8 Weeks, 6 Months, 12 Months	PROMIS Pain Interference; 8-40; higher scores indicate more pain interference
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
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 9-Item (PHQ-9); 0-27; higher score indicates more symptoms of depression
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
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
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
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 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
Pain Intensity	0 Weeks, 8 Weeks, 6 Months, 12 Months	Graded Chronic Pain Scale (GCPS); 0-100; higher scores indicate greater pain intensity

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States