Clinical trial NCT02811718: Resiliency Training for Patients With NF2 Via Videoconferencing With Skype
Official title: Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurofibromatosis 2
Keywords: Stress Management
Resiliency
Skype
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: The Children's Tumor Foundation
First posted: 2016-06-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Quality of Life (WHOQOL-BREF)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32 and week 64)
measure: Penn Acoustic Neuroma Quality-of Life Scale (PANQOL)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32 and week 64)
Secondary outcomes:
measure: Perceived Stress Scale (PSS-10)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: The 14-Item Resiliency Scale (RS-14)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Patient Health Questionnaire (PHQ)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Cognitive and Affective Mindfulness Scale (CAMS)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Life Orientation Test (LOT) Optimism Scale
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: The Gratitude Questionnaire (GQ-6)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Measure of Current Status (MOCS-A)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Medical Outcomes Study (MOS) Social Support Survey
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Other outcomes:
measure: Intent to Attend
timeFrame: Baseline (week 0)
measure: Date of Birth, Age, Gender, Race, Ethnicity, Marital Status, Education Status, Employment Status, and hearing status of subjects with NF2
timeFrame: Baseline (week 0)
measure: Credibility Questionnaire
timeFrame: Baseline (week 0)
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post-intervention (week 8)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
References: