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Resiliency Training in Adolescents With NF1 and NF2

NCT ID: NCT03873610

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-15

Study Completion Date

2026-02-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neurofibromatoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Stress and Symptom Management Program 1

Group Type EXPERIMENTAL

Stress and Symptom Management Program 1

Intervention Type BEHAVIORAL

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 2

Group Type EXPERIMENTAL

Stress and Symptom Management Program 2

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ana-Maria Vranceanu, PhD

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana-Maria Vranceanu, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2019P000625

Identifier Type: -

Identifier Source: org_study_id