Resiliency Training in Adolescents With NF1 and NF2

Neurofibromatoses Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03873610
• Other study ID #: 2019P000625
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2019
• Est. completion date: April 1, 2024

Study information

• Verified date: September 2021
• Source: Massachusetts General Hospital
• Contact: Ana-Maria Vranceanu, PhD
• Phone: 6176437996
• Email: avranceanu[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis 1

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Social relationships 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	Environmental 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	Depression	Patient Health Questionnaire (PHQ-9) Adolescent Version; 0-27; Higher score indicates more symptoms of depression	0 weeks, 8 weeks, 6 months, 12 months
Secondary	Anxiety	Generalized Anxiety Disorder (GAD-7) Questionnaire; 0-21; Higher score indicates more symptoms of anxiety	0 weeks, 8 weeks, 6 months, 12 months
Secondary	Pain intensity	Numerical Rating Scale; 0-10; Higher score indicates more intense pain.	0 weeks, 8 weeks, 6 months, 12 months
Secondary	Pain interference	Pain Interference Index (PII); 0-36; Higher score indicates more pain interference	0 weeks, 8 weeks, 6 months, 12 months