NCT03873610

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

December 15, 2019

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

6.2 years

First QC Date

March 12, 2019

Last Update Submit

December 19, 2025

Conditions

Neurofibromatoses

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Social relationships Quality of Life

    0 weeks, 8 weeks, 6 months,12 months

  • Environmental Quality of Life

    0 weeks, 8 weeks, 6 months, 12 months

  • Depression

    0 weeks, 8 weeks, 6 months, 12 months

  • Anxiety

    0 weeks, 8 weeks, 6 months, 12 months

  • Pain intensity

    0 weeks, 8 weeks, 6 months, 12 months

  • +1 more secondary outcomes

Study Arms (2)

Stress and Symptom Management Program 1

EXPERIMENTAL
Behavioral: Stress and Symptom Management Program 1

Stress and Symptom Management 2

EXPERIMENTAL
Behavioral: Stress and Symptom Management Program 2

Interventions

Stress and Symptom Management Program 1BEHAVIORAL

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.

Stress and Symptom Management Program 1
Stress and Symptom Management Program 2BEHAVIORAL

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.

Stress and Symptom Management 2

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02140, United States

Location

MeSH Terms

Conditions

Neurofibromatoses

Condition Hierarchy (Ancestors)

NeurofibromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplastic Syndromes, HereditaryNeurocutaneous SyndromesNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ana-Maria Vranceanu, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 13, 2019

Study Start

December 15, 2019

Primary Completion

February 20, 2026

Study Completion

February 20, 2026

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)