Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Resiliency Training in Adolescents With NF1 and NF2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03873610
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : December 2, 2019
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Ana-Maria Vranceanu, PhD, Massachusetts General Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Neurofibromatoses Behavioral: Stress and Symptom Management Program 1 Behavioral: Stress and Symptom Management Program 2 Not Applicable

Detailed Description:

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.


Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Resiliency Training in Adolescents With NF1 and NF2; A Randomized Controlled Trial Via Secure Live Video Conferencing to Improve Emotional, Social and Physical Function
Estimated Study Start Date : November 27, 2019
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Stress and Symptom Management Program 1 Behavioral: 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.
Experimental: Stress and Symptom Management 2 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in Physical Health 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

  2. Change in Psychological Health 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


Secondary Outcome Measures :
  1. Social relationships 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

  2. 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

  3. Depression [ Time Frame: 0 weeks, 8 weeks, 6 months, 12 months ]
    Patient Health Questionnaire (PHQ-9) Adolescent Version; 0-27; Higher score indicates more symptoms of depression

  4. Anxiety [ Time Frame: 0 weeks, 8 weeks, 6 months, 12 months ]
    Generalized Anxiety Disorder (GAD-7) Questionnaire; 0-21; Higher score indicates more symptoms of anxiety

  5. Pain intensity [ Time Frame: 0 weeks, 8 weeks, 6 months, 12 months ]
    Numerical Rating Scale; 0-10; Higher score indicates more intense pain.

  6. Pain interference [ Time Frame: 0 weeks, 8 weeks, 6 months, 12 months ]
    Pain Interference Index (PII); 0-36; Higher score indicates more pain interference


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873610


Contacts
Layout table for location contacts
Contact: Ana-Maria Vranceanu, PhD 6176437996 avranceanu@mgh.harvard.edu
Contact: Mira R Reichman, BA 617-643-4127 mreichman@mgh.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02140
Principal Investigator: Ana-Maria Vranceanu, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
United States Department of Defense
Investigators
Layout table for investigator information
Principal Investigator: Ana-Maria Vranceanu, PhD Massachusetts General Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Ana-Maria Vranceanu, PhD, Principle Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03873610     History of Changes
Other Study ID Numbers: 2019P000625
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neurofibromatoses
Neurofibromatosis 1
Neurofibroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
 Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Neoplasms
Nervous System Neoplasms