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Resiliency Training in Adolescents With NF1 and NF2

Primary Purpose

Neurofibromatoses

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stress and Symptom Management Program 1

Stress and Symptom Management Program 2

About this trial

This is an interventional supportive care trial for Neurofibromatoses

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Stress and Symptom Management Program 1

Stress and Symptom Management 2

Arm Description

Outcomes

Primary Outcome Measures

Change in Physical Health Quality of Life

World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL

Change in Psychological Health Quality of Life

World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL

Secondary Outcome Measures

Social relationships Quality of Life

World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL

Environmental Quality of Life

World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL

Depression

Patient Health Questionnaire (PHQ-9) Adolescent Version; 0-27; Higher score indicates more symptoms of depression

Anxiety

Generalized Anxiety Disorder (GAD-7) Questionnaire; 0-21; Higher score indicates more symptoms of anxiety

Pain intensity

Numerical Rating Scale; 0-10; Higher score indicates more intense pain.

Pain interference

Pain Interference Index (PII); 0-36; Higher score indicates more pain interference

Full Information

NCT ID

NCT03873610

First Posted

March 12, 2019

Last Updated

September 7, 2021

Sponsor

Massachusetts General Hospital

Collaborators

United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT03873610

Brief Title

Resiliency Training in Adolescents With NF1 and NF2

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Recruiting

Study Start Date

December 15, 2019 (Actual)

Primary Completion Date

April 1, 2023 (Anticipated)

Study Completion Date

April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurofibromatoses

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stress and Symptom Management Program 1

Arm Type

Experimental

Arm Title

Stress and Symptom Management 2

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Stress and Symptom Management Program 1

Intervention Description

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

Intervention Name(s)

Stress and Symptom Management Program 2

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Physical Health Quality of Life

Description

World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL

Time Frame

0 weeks, 8 weeks, 6 months,12 months

Title

Change in Psychological Health Quality of Life

Description

World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL

Time Frame

0 weeks, 8 weeks, 6 months,12 months

Secondary Outcome Measure Information:

Title

Social relationships Quality of Life

Description

World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL

Time Frame

0 weeks, 8 weeks, 6 months,12 months

Title

Environmental Quality of Life

Description

World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL

Time Frame

0 weeks, 8 weeks, 6 months, 12 months

Title

Depression

Description

Patient Health Questionnaire (PHQ-9) Adolescent Version; 0-27; Higher score indicates more symptoms of depression

Time Frame

0 weeks, 8 weeks, 6 months, 12 months

Title

Anxiety

Description

Generalized Anxiety Disorder (GAD-7) Questionnaire; 0-21; Higher score indicates more symptoms of anxiety

Time Frame

0 weeks, 8 weeks, 6 months, 12 months

Title

Pain intensity

Description

Numerical Rating Scale; 0-10; Higher score indicates more intense pain.

Time Frame

0 weeks, 8 weeks, 6 months, 12 months

Title

Pain interference

Description

Pain Interference Index (PII); 0-36; Higher score indicates more pain interference

Time Frame

0 weeks, 8 weeks, 6 months, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ana-Maria Vranceanu, PhD

Phone

6176437996

avranceanu@mgh.harvard.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Mira R Reichman, BA

Phone

617-643-4127

mreichman@mgh.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ana-Maria Vranceanu, PhD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02140

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ana-Maria Vranceanu, PhD

12. IPD Sharing Statement

Plan to Share IPD

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Resiliency Training in Adolescents With NF1 and NF2

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