Resiliency Training for Patients With NF2 Via Videoconferencing With Skype

NCT02811718 | Completed

• 1 other identifier: 2013P002605b
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

Stress Management; Resiliency; Skype

Outcome Measures

Primary Outcomes (2)

• Quality of Life (WHOQOL-BREF)

  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.

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

• Penn Acoustic Neuroma Quality-of Life Scale (PANQOL)

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

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

Secondary Outcomes (8)

• Perceived Stress Scale (PSS-10)

  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)

• Patient Health Questionnaire (PHQ)

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

• Cognitive and Affective Mindfulness Scale (CAMS)

  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)

Other Outcomes (4)

• Intent to Attend

  Baseline (week 0)

• Date of Birth, Age, Gender, Race, Ethnicity, Marital Status, Education Status, Employment Status, and hearing status of subjects with NF2

  Baseline (week 0)

• Credibility Questionnaire

  Baseline (week 0)

Study Arms (2)

Stress Management Group 1

EXPERIMENTAL

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

Behavioral: Stress Management Group 1

Stress Management Group 2

EXPERIMENTAL

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

Behavioral: Stress Management Group 2

Interventions

Stress Management Group 1 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 1

Stress Management Group 2 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• The Children's Tumor Foundation: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Neurofibromatosis 2

Condition Hierarchy (Ancestors)

Neuroma, Acoustic; Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neurofibromatoses; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neuroma; Neoplastic Syndromes, Hereditary; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ana-Maria Vranceanu, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 23, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

US (1)