Resiliency Training for Patients With NF2 Via Videoconferencing With Skype
- Conditions
- Neurofibromatosis 2
- Interventions
- Behavioral: Stress Management Group 1Behavioral: Stress Management Group 2
- Registration Number
- NCT02811718
- Lead Sponsor
- Massachusetts General Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stress Management Group 1 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. Stress Management Group 2 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.
- Primary Outcome Measures
Name Time Method Penn Acoustic Neuroma Quality-of Life Scale (PANQOL) Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32 and week 64) The PANQOL measures quality of life specifically for patients with NF2.
Quality of Life (WHOQOL-BREF) Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32 and week 64) 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.
- Secondary Outcome Measures
Name Time Method Cognitive and Affective Mindfulness Scale (CAMS) Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) The CAMS measures the degree to which individuals experience their thoughts and feelings.
The 14-Item Resiliency Scale (RS-14) Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) The RS-14 measures stress coping ability in the face of adversity.
Perceived Stress Scale (PSS-10) Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) The PSS is a widely used psychological instrument for the measurement of the perception of stress. This 10-itam scale is designed to measure the degree to which situations in one's life are appraised, or considered stressful. The scores range from 0-40, with a higher score indicating higher perceived stress. Items were designed to detect how unpredictable, uncontrollable and overloaded respondents find their lives.
The Gratitude Questionnaire (GQ-6) Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) The GQ-6 revised is a 6-item measure that assesses individual differences in the proneness to experience gratitude in daily life. Scores range from 6-42, with a higher score indicating a greater sense of gratitude.
Medical Outcomes Study (MOS) Social Support Survey Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) The MOS Social Support Survey measures various dimensions of social support.
Measure of Current Status (MOCS-A) Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) The MOCS-A is a 13-item measure assessing participants' current self-perceived status on several skills such as: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. Responses are made on a 7-point scale with higher scores reflecting higher life satisfaction.
Patient Health Questionnaire (PHQ) Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) The PHQ measures symptoms of depression and functional impairment.
Life Orientation Test (LOT) Optimism Scale Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism.
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States