Resiliency Training in Adolescents With NF1 and NF2

Resiliency Training in Adolescents With NF1 and NF2; A Randomized Controlled Trial Via Secure Live Video Conferencing to Improve Emotional, Social and Physical Function

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neurofibromatoses
• Intervention / Treatment: Behavioral: Stress and Symptom Management Program 1; Behavioral: Stress and Symptom Management Program 2

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02140
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Has a diagnosis of NF1 or NF2 and is between the ages of 12-17
• Is capable of completing and fully understanding the informed consent process/assent and the study procedures and assessments in English; has parental approval for participation
• English speaking and at least a 3rd grade self-reported and parent reported reading level
• Self reported/parent reported difficulties coping with stress and NF symptoms

Exclusion Criteria:

• Has major medical co-morbidity not NF related expected to worsen in the next 12 months
• Recent (within past 3 months) change in antidepressant medication
• Recent participation in cognitive behavioral therapy or relaxation therapy (within past 3 months)
• Has significant mental health diagnosis requiring immediate treatment (e.g., untreated bipolar disorder, psychotic disorder, active substance dependence)
• Unable or unwilling to complete assessments electronically via REDCap
• Unable or unwilling to participate in group videoconferencing sessions
• Unable or unwilling to participate along with at least 1 parent in a video screening session

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stress and Symptom Management Program 1	Behavioral: Stress and Symptom Management Program 1; 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.
Experimental: Stress and Symptom Management 2	Behavioral: Stress and Symptom Management Program 2; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Ana-Maria Vranceanu, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2019
• Primary Completion (Estimated): February 20, 2026
• Study Completion (Estimated): February 20, 2026

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 13, 2019

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Genetic Diseases, Inborn; Neoplasms by Histologic Type; Neurodegenerative Diseases; Neoplasms, Nerve Tissue; Heredodegenerative Disorders, Nervous System; Nerve Sheath Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Neurofibroma; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurofibromatoses
• Other Study ID Numbers: 2019P000625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No