Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing

December 18, 2025 updated by: Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

228

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Other Names:
  • SMP2
Experimental: 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.
Behavioral: 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.
Other Names:
  • SMP2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Physical Quality of Life
Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
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
Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
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
Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
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
Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
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
Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
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
Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
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
Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
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
Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
Gratitude Questionnaire 6-Item (GQ-6); 6-42; higher scores indicate greater gratitude
0 Weeks, 8 Weeks, 6 Months, 12 Months
Optimism
Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
Life Orientation Test-Revised (LOT-R); 0-40; higher scores indicate greater optimism
0 Weeks, 8 Weeks, 6 Months, 12 Months
Coping Strategies
Time Frame: 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
0 Weeks, 8 Weeks, 6 Months, 12 Months
Mindfulness
Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
Cognitive and Affective Mindfulness Scale (CAMS); 10-40; higher scores indicate greater mindfulness
0 Weeks, 8 Weeks, 6 Months, 12 Months
Empathy
Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
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
Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
Graded Chronic Pain Scale (GCPS); 0-100; higher scores indicate greater pain intensity
0 Weeks, 8 Weeks, 6 Months, 12 Months
Pain Interference
Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
PROMIS Pain Interference; 8-40; higher scores indicate more pain interference
0 Weeks, 8 Weeks, 6 Months, 12 Months
Stress
Time Frame: 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
0 Weeks, 8 Weeks, 6 Months, 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Ana-Maria Vranceanu, PhD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

December 6, 2017

First Submitted That Met QC Criteria

January 19, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Estimated)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017P000143
  • W81XWH-17-1-0121 (Other Grant/Funding Number: United States Department of Defense)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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