Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

Brief Title

Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

Official Title

Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

Brief Summary

      This study tests the efficacy of an 8-week, Skype-based, group resiliency training
      intervention (The Relaxation Response Resiliency Program) for improving psychological stress
      in patients with Neurofibromatosis. A control group will receive a general health education
      curriculum. The investigators hypothesize that patients will improve on measures of
      psychological stress as a result of the resiliency program.

      A substudy (Unique Protocol ID: 2013P002605b) has been approved to test this study on a
      sub-population: patients with NF2 who are hard of hearing.
    



Study Type

Interventional


Primary Outcome

Satisfaction with Life (SWL)

Secondary Outcome

 Perceived Stress Scale (PSS-10)

Condition

Neurofibromatosis

Intervention

The Relaxation Response Resiliency Program (3RP) via Skype

Study Arms / Comparison Groups

 Relaxation Response Resiliency Program
Description:  Participants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills.

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

65

Start Date

March 2014

Completion Date

July 2015

Primary Completion Date

July 2015

Eligibility Criteria

        Inclusion Criteria:

          1. Age 18 or older

          2. Can read and speak English at or above the 6th grade level

          3. Diagnosis of neurofibromatosis type 1, neurofibromatosis type 2, or schwannomatosis

        Exclusion Criteria:

          1. 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)

          2. Recent (within past 3 months) change in antidepressant medication

          3. Use of formal relaxation training (including past participation in a mind-body
             program), currently or in the past 6 months.

          4. Unable or unwilling to sign the informed consent documents

          5. Unable or unwilling to complete psychological assessments online via the REDCap
             system.

          6. Unable or unwilling to participate in an intervention delivered via videoconferencing
             with Skype.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ana-Maria Vranceanu, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02298270

Organization ID

2013P002605a


Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital

Collaborators

 The Children's Tumor Foundation

Study Sponsor

Ana-Maria Vranceanu, PhD, Principal Investigator, MGH


Verification Date

June 2016