Resiliency Training for Patients With NF2 Via Videoconferencing With Skype

NCT ID: NCT02811718

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-07-31

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.

Conditions

Neurofibromatosis 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Stress Management Group 1

Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.

Group Type: EXPERIMENTAL

Stress Management Group 1

Intervention Type: BEHAVIORAL

Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.

Stress Management Group 2

Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.

Group Type: EXPERIMENTAL

Stress Management Group 2

Intervention Type: BEHAVIORAL

Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.

Interventions

Stress Management Group 1

Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.

Intervention Type: BEHAVIORAL

Stress Management Group 2

Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Age 18 or older

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

3. Patients with NF2 who are deaf or have severe hearing loss.

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.

7. Unwilling to use either CART or ASL for communication during the Skype groups.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Children's Tumor Foundation

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ana-Maria Vranceanu, PhD

Clinical Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana-Maria Vranceanu, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2013P002605b

Identifier Type: -

Identifier Source: org_study_id