Resiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype

Massachusetts General Hospital1 site in 1 country51 target enrollmentJanuary 2015

ConditionsNeurofibromatoses

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neurofibromatoses
Sponsor: Massachusetts General Hospital
Enrollment: 51
Locations: 1
Primary Endpoint: Quality of life (WHO-QOLBREFadol)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this research is to adapt the NF-specific adult version of the Skype 3RP for use with adolescents, and to test its feasibility, acceptability, and preliminary effect in improving quality of life, and in decreasing stress and psychological distress.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

December 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Massachusetts General Hospital

Responsible Party

Principal Investigator

Ana-Maria Vranceanu, PhD

Clinical Psychologist

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

•Must be between the ages of 12 and 17
•Can read and speak English at or above the 6th grade level
•Diagnosis of neurofibromatosis type 1 or neurofibromatosis type 2 by a specialized medical provider

Exclusion Criteria

•Severe active or untreated major mental illness that would interfere with study participation, to be determined at the discretion of the study investigator (e.g. untreated psychosis or suicidality)
•Recent (within past 3 months) change in antidepressant medication
•Use of formal relaxation training (including past participation in a mind-body program), currently or in the past 6 months
•Unable or unwilling to sign the informed consent documents
•Unable or unwilling to participate in an intervention delivered via videoconferencing with Skype

Outcomes

Primary Outcomes

Quality of life (WHO-QOLBREFadol)

Time Frame: Change between Baseline (week0), Post-intervention (Week8) and Follow Up (Week 36)

Measures quality of life

Secondary Outcomes

Generalized Anxiety Disorder 7-item (GAD-7) scale(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
Perceived Stress Scale (PSS-10)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
Pain Interference Index (PII)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
Measure of Current Status (MOCS) Part A(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
The Pain Catastrophizing Scale - Child Version (PCS-C)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
Patient Health Questionnaire for Adolescents (PHQ-A)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
Interpersonal Reactivity Index (IRI)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
Epworth Sleepiness Scale-Revised for Children (ESS)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
Gratitude Questionnaire Six-Item Form (GQ-6)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
Child and Adolescent Mindfulness Measure (CAMM)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
Life Orientation Test (LOT) Optimism Scale(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
Satisfaction with life adolescent(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being Scale (FACIT-Sp)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
MOS (Support/Empathy)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
Quality of Life (WHOQOL-BREF)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))