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Resiliency Training for Neurofibromatosis

N/A

Waitlist Available

Led By Ana-Maria Vranceanu, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a diagnosis of NF1 or NF2 and is between the ages of 12-17

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 weeks, 8 weeks, 6 months,12 months

Awards & highlights

Study Summary

This trial is testing two stress and symptom management programs for adolescents with Neurofibromatosis 1 and 2. The programs are 8 weeks long and done in a group setting.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since the interventions are non-medical stress management programs, there may not be direct side effects like those associated with medications; however, participants might experience emotional discomfort while discussing personal topics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am diagnosed with NF1 or NF2 and am between 12-17 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 weeks, 8 weeks, 6 months,12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 weeks, 8 weeks, 6 months,12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 weeks, 8 weeks, 6 months,12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Physical Health Quality of Life

Change in Psychological Health Quality of Life

Secondary outcome measures

Anxiety

Depression

Environmental Quality of Life

+3 more

Trial Design

2Treatment groups

Experimental Treatment

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

Group II: Stress and Symptom Management 2Experimental Treatment1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,155 Total Patients Enrolled

2 Trials studying Neurofibromatosis

151 Patients Enrolled for Neurofibromatosis

United States Department of DefenseFED

861 Previous Clinical Trials

226,994 Total Patients Enrolled

1 Trials studying Neurofibromatosis

19 Patients Enrolled for Neurofibromatosis

Ana-Maria Vranceanu, PhDPrincipal Investigator - Massachusetts General Hospital

Massachusetts General Hospital

20 Previous Clinical Trials

1,886 Total Patients Enrolled

2 Trials studying Neurofibromatosis

151 Patients Enrolled for Neurofibromatosis

Media Library

Stress and Symptom Management Program 1 Clinical Trial Eligibility Overview. Trial Name: NCT03873610 — N/A

Neurofibromatosis Research Study Groups: Stress and Symptom Management Program 1, Stress and Symptom Management 2

Neurofibromatosis Clinical Trial 2023: Stress and Symptom Management Program 1 Highlights & Side Effects. Trial Name: NCT03873610 — N/A

Stress and Symptom Management Program 1 2023 Treatment Timeline for Medical Study. Trial Name: NCT03873610 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being sought for this research endeavor?

"Affirmative, the information located on clinicaltrials.gov verify that this medical trial is actively enrolling patients. The listing was initially posted to the directory on December 15th 2019 and has since been revised on September 7th 2021. 200 participants are needed from 1 different location for the study to be a success."

Answered by AI

Who can participate in this medical research?

"This medical trial is seeking two-hundred patients with neurofibromatoses between the ages of twelve and seventeen. Eligibility demands that one must have been diagnosed NF1 or NF2, be able to comprehend theinformed consent process/assent in English, receive parental approval for participation, possess a minimum 3rd grade reading fluency in English, and struggle to cope with stress induced by their condition."

Answered by AI

What is the desired outcome of this clinical experiment?

"This medical research will measure Change in Psychological Health Quality of Life over a 0-week, 8-week, 6 month and 12 month period as its primary outcome indicator. The secondary outcomes tracked include Pain Interference Index (PII), Patient Health Questionnaire (PHQ-9) Adolescent Version for Depression symptoms, and Generalized Anxiety Disorder (GAD-7) scores to track levels of anxiety."

Answered by AI

For what age demographic is enrollment accepted in this experiment?

"This scientific research is open to participants aged 12 and above, but below 17 years old."

Answered by AI

How many individuals are involved in the experiment at maximum capacity?

"Affirmative, the information available on clinicaltrials.gov shows that this research project is currently recruiting. Initially posted in December 2019 and last modified on September 2021, it requires 200 participants to be enrolled at 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Resiliency Training in Adolescents With NF1 and NF2

Ana-Maria Vranceanu, PhD 2019. "Resiliency Training in Adolescents With NF1 and NF2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03873610.

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