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Clinical Trials/NCT03406208
NCT03406208
Completed
Not Applicable

Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing

Massachusetts General Hospital1 site in 1 country228 target enrollmentOctober 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurofibromatoses
Sponsor
Massachusetts General Hospital
Enrollment
228
Locations
1
Primary Endpoint
Change in Physical Quality of Life
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

The aims of this study are to compare the effect and durability of two stress and symptom management programs tailored for patients with neurofibromatosis on quality of life and psychosocial functioning.

Detailed Description

The aims of this study are to compare the effect of two stress and symptom management programs tailored for patients 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, anxiety, distress, mindfulness, gratitude, social support, empathy, optimism, coping, pain intensity and pain interference.

Registry
clinicaltrials.gov
Start Date
October 1, 2017
End Date
February 28, 2022
Last Updated
4 months 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

  • Has a diagnosis of NF1, NF2, or Schwannomatosis
  • 18 years of age or older
  • Is capable of completing and fully understanding the informed consent process, study procedures, and study assessments in English
  • At least 6th grade self-reported reading level
  • Self-reported difficulties coping with stress and NF-symptoms
  • Score of 6 or higher on Perceived Stress Scale 4-Item (PSS-4)

Exclusion Criteria

  • Has major medical comorbidity not NF related expected to worsen in the next 12 months
  • Recent (within past 3 months) change in antidepressant medication
  • Recent (within past 3 months) participation in cognitive behavioral therapy or relaxation therapy
  • Has significant mental health diagnosis requiring immediate treatment (e.g., bipolar disorder, psychotic disorder, active substance use dependence)
  • Unable or unwilling to complete assessments electronically via REDCap
  • Unable or unwilling to participate in group videoconferencing sessions

Outcomes

Primary Outcomes

Change in Physical 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

Change in Psychological 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 Outcomes

  • Pain Interference(0 Weeks, 8 Weeks, 6 Months, 12 Months)
  • Stress(0 Weeks, 8 Weeks, 6 Months, 12 Months)
  • Social Quality of Life(0 Weeks, 8 Weeks, 6 Months, 12 Months)
  • Environmental Quality of Life(0 Weeks, 8 Weeks, 6 Months, 12 Months)
  • Depression(0 Weeks, 8 Weeks, 6 Months, 12 Months)
  • Coping Strategies(0 Weeks, 8 Weeks, 6 Months, 12 Months)
  • Mindfulness(0 Weeks, 8 Weeks, 6 Months, 12 Months)
  • Empathy(0 Weeks, 8 Weeks, 6 Months, 12 Months)
  • Anxiety(0 Weeks, 8 Weeks, 6 Months, 12 Months)
  • Gratitude(0 Weeks, 8 Weeks, 6 Months, 12 Months)
  • Optimism(0 Weeks, 8 Weeks, 6 Months, 12 Months)
  • Social Support(0 Weeks, 8 Weeks, 6 Months, 12 Months)
  • Pain Intensity(0 Weeks, 8 Weeks, 6 Months, 12 Months)

Study Sites (1)

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