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Clinical Trials/NCT02811718
NCT02811718
Completed
Not Applicable

Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

Massachusetts General Hospital1 site in 1 country45 target enrollmentJuly 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurofibromatosis 2
Sponsor
Massachusetts General Hospital
Enrollment
45
Locations
1
Primary Endpoint
Penn Acoustic Neuroma Quality-of Life Scale (PANQOL)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The aim of this study is to determine, whether the 3RP is feasible, accepted and efficacious and durable when delivered via Skype to patients with neurofibromatosis type 2 (NF2) who are deaf or have severe hearing loss using Communication Access Realtime Translation (CART) and/or American Sign Language (ASL).

This will be a substudy of the IRB-approved protocol #2013P002605. It is the same study except it is looking at a particular sub-population: patients with NF2 who are hard of hearing.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
July 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ana-Maria Vranceanu, PhD

Clinical Psychologist

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Age 18 or older
  • Can read and speak English at or above the 6th grade level
  • Patients with NF2 who are deaf or have severe hearing loss.

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 complete psychological assessments online via the REDCap system.
  • Unable or unwilling to participate in an intervention delivered via videoconferencing with Skype.
  • Unwilling to use either CART or ASL for communication during the Skype groups.

Outcomes

Primary Outcomes

Penn Acoustic Neuroma Quality-of Life Scale (PANQOL)

Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32 and week 64)

The PANQOL measures quality of life specifically for patients with NF2.

Quality of Life (WHOQOL-BREF)

Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32 and week 64)

The WHOQOL-BREF comprises of 26 items which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.

Secondary Outcomes

  • Cognitive and Affective Mindfulness Scale (CAMS)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
  • The 14-Item Resiliency Scale (RS-14)(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))
  • The Gratitude Questionnaire (GQ-6)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
  • Medical Outcomes Study (MOS) Social Support Survey(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
  • Measure of Current Status (MOCS-A)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
  • Patient Health Questionnaire (PHQ)(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))

Study Sites (1)

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