Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing

Brief Title

Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing

Official Title

Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing

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.
    


Study Type

Interventional


Primary Outcome

Change in Physical Quality of Life

Secondary Outcome

 Social Quality of Life

Condition

Neurofibromatoses

Intervention

Stress and Symptom Management Program 1

Study Arms / Comparison Groups

 Stress and Symptom Management Program 1
Description:  The Stress and Symptom Management Program 1 (SMP1) introduces and reinforces stress and symptom management skills. The program consists of 8 weekly sessions (90 minutes each), delivered through live videoconferencing.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

224

Start Date

October 1, 2017

Completion Date

January 30, 2022

Primary Completion Date

January 30, 2022

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ana-Maria Vranceanu, PhD, 6176437996, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03406208

Organization ID

2017P000143


Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital


Study Sponsor

Ana-Maria Vranceanu, PhD, Principal Investigator, Massachusetts General Hospital


Verification Date

January 2018