Resiliency Training for Neurofibromatosis

MR
AV
Overseen ByAna-Maria Vranceanu, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two programs designed to help teens with Neurofibromatosis 1 or 2 (NF1 or NF2) manage stress and symptoms more effectively. Researchers aim to determine which program works best through online group sessions over eight weeks. Teens diagnosed with NF1 or NF2, who speak English, and struggle with stress or symptoms, are ideal candidates for this study. As an unphased trial, it provides a unique opportunity for teens to access potentially helpful programs and contribute to valuable research.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but if you have recently changed your antidepressant medication in the past 3 months, you may not be eligible to participate.

What prior data suggests that these stress and symptom management programs are safe for adolescents with Neurofibromatosis?

Research has shown that stress and symptom management programs designed for individuals with neurofibromatosis can be beneficial. Studies have found that these programs improve both physical and mental well-being. Participants often report fewer issues with pain and stress.

Regarding safety, these programs are generally well-tolerated. No reports of negative effects exist because they focus on mind-body skills, such as relaxation and stress management. This training is non-invasive and safe. Therefore, those considering joining such a trial can feel assured that it aims to provide a safe and supportive experience.12345

Why are researchers excited about this trial?

Researchers are excited about the Resiliency Training for Neurofibromatosis because it focuses on stress and symptom management, which is a fresh approach compared to traditional treatments like surgery, chemotherapy, or radiation. Unlike these methods, which directly target the physical manifestations of neurofibromatosis, the stress and symptom management programs aim to improve patients' quality of life by addressing the psychological and emotional challenges they face. This approach is designed to empower patients with coping strategies to manage their condition's impact on daily life, offering a holistic and supportive complement to existing medical treatments.

What evidence suggests that this trial's treatments could be effective for managing stress and symptoms in adolescents with Neurofibromatosis?

Research has shown that mind-body skills training programs can significantly enhance both the physical and mental quality of life for individuals with neurofibromatosis, a genetic condition that causes tumors to grow on nerve tissue. Studies have found that participants in these programs experienced long-term benefits, such as reduced stress and improved emotional health. One study noted that many teenagers completed the training and follow-up sessions and expressed satisfaction with the program. These treatments aim to build resilience, helping patients manage symptoms and stress more effectively. In this trial, participants will join one of two programs: Stress and Symptom Management Program 1 or Stress and Symptom Management Program 2. Both programs are designed to provide these benefits, potentially making everyday life easier for those with neurofibromatosis.12678

Who Is on the Research Team?

AV

Ana-Maria Vranceanu, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

Adolescents aged 12-17 with Neurofibromatosis type 1 or 2, who can understand and consent to the study in English with parental approval. Participants should have difficulties managing stress and NF symptoms but no major unrelated medical issues, recent changes in antidepressants, or recent cognitive therapy.

Inclusion Criteria

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
I am diagnosed with NF1 or NF2 and am between 12-17 years old.
I struggle to handle stress and symptoms of my condition.

Exclusion Criteria

I cannot or do not want to join group video calls.
Has significant mental health diagnosis requiring immediate treatment (e.g., untreated bipolar disorder, psychotic disorder, active substance dependence)
Unable or unwilling to participate along with at least 1 parent in a video screening session
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week stress and symptom management program via secure live video conferencing

8 weeks
Weekly virtual group sessions

Follow-up

Participants are monitored for changes in quality of life, depression, pain, and anxiety

12 months
Assessments at 0 weeks, 8 weeks, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Stress and Symptom Management Program 1
  • Stress and Symptom Management Program 2

Trial Overview

The trial is testing two different resiliency training programs delivered through live video over eight weeks to see how they help adolescents with Neurofibromatosis manage stress and symptoms related to their condition.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Stress and Symptom Management Program 1Experimental Treatment1 Intervention
Group II: Stress and Symptom Management 2Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Citations

Effect of Mind-Body Skills Training on Quality of Life for ...

A mind-body skills training program tailored to patients with neurofibromatosis can have long-term benefits on physical and psychological quality of life.

Resiliency Training in Adolescents With NF1 and NF2

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 ...

A pilot randomized controlled trial

Forty-five adolescents (88%) completed posttreatment, and 37 (82%) completed 6-month follow-up. Satisfaction was high in both conditions. The RY-NF showed ...

Mind-Body Treatment for International English-Speaking ...

Objective: The objective of this study is to evaluate the efficacy of the Relaxation Response Resiliency Program for NF versus the Health ...

Psychological resiliency explains the relationship between ...

Patients with NF experience emotional distress, including depression, anxiety, and perceived stress, at rates higher than the general population [6] and ...

Mind-Body Treatment for International English-Speaking ...

The 3RP-NF is a comprehensive, multimodal treatment program designed to improve the ability to cope with NF symptoms and stress. The program ...

Improvements in pain interference among geographically ...

Improvements in pain interference among geographically diverse adults with neurofibromatosis: Results from a fully powered randomized controlled trial - PMC.

Cognition and behavior in neurofibromatosis type 1

Studies consistently show that NF1 is associated with a 0.6–0.8 standard deviation reduction in IQ, with verbal and nonverbal intellectual ...