Resiliency Training for Patients With NF2 Via Videoconferencing With Skype
Primary Purpose
Neurofibromatosis 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress Management Group 1
Stress Management Group 2
Sponsored by
About this trial
This is an interventional treatment trial for Neurofibromatosis 2 focused on measuring Stress Management, Resiliency, Skype
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Stress Management Group 1
Stress Management Group 2
Arm Description
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
Outcomes
Primary Outcome Measures
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.
Penn Acoustic Neuroma Quality-of Life Scale (PANQOL)
The PANQOL measures quality of life specifically for patients with NF2.
Secondary Outcome Measures
Perceived Stress Scale (PSS-10)
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 14-Item Resiliency Scale (RS-14)
The RS-14 measures stress coping ability in the face of adversity.
Patient Health Questionnaire (PHQ)
The PHQ measures symptoms of depression and functional impairment.
Cognitive and Affective Mindfulness Scale (CAMS)
The CAMS measures the degree to which individuals experience their thoughts and feelings.
Life Orientation Test (LOT) Optimism Scale
The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism.
The Gratitude Questionnaire (GQ-6)
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.
Measure of Current Status (MOCS-A)
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.
Medical Outcomes Study (MOS) Social Support Survey
The MOS Social Support Survey measures various dimensions of social support.
Full Information
NCT ID
NCT02811718
First Posted
June 21, 2016
Last Updated
August 15, 2018
Sponsor
Massachusetts General Hospital
Collaborators
The Children's Tumor Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02811718
Brief Title
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
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
The Children's Tumor Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurofibromatosis 2
Keywords
Stress Management, Resiliency, Skype
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stress Management Group 1
Arm Type
Experimental
Arm Description
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
Arm Title
Stress Management Group 2
Arm Type
Experimental
Arm Description
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
Intervention Type
Behavioral
Intervention Name(s)
Stress Management Group 1
Intervention Description
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
Intervention Type
Behavioral
Intervention Name(s)
Stress Management Group 2
Intervention Description
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
Primary Outcome Measure Information:
Title
Quality of Life (WHOQOL-BREF)
Description
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.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32 and week 64)
Title
Penn Acoustic Neuroma Quality-of Life Scale (PANQOL)
Description
The PANQOL measures quality of life specifically for patients with NF2.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32 and week 64)
Secondary Outcome Measure Information:
Title
Perceived Stress Scale (PSS-10)
Description
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.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
The 14-Item Resiliency Scale (RS-14)
Description
The RS-14 measures stress coping ability in the face of adversity.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Patient Health Questionnaire (PHQ)
Description
The PHQ measures symptoms of depression and functional impairment.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Cognitive and Affective Mindfulness Scale (CAMS)
Description
The CAMS measures the degree to which individuals experience their thoughts and feelings.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Life Orientation Test (LOT) Optimism Scale
Description
The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
The Gratitude Questionnaire (GQ-6)
Description
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.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Measure of Current Status (MOCS-A)
Description
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.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Medical Outcomes Study (MOS) Social Support Survey
Description
The MOS Social Support Survey measures various dimensions of social support.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Other Pre-specified Outcome Measures:
Title
Intent to Attend
Description
Measures how likely and how motivated the participants is to attend the next session.
Time Frame
Baseline (week 0)
Title
Date of Birth, Age, Gender, Race, Ethnicity, Marital Status, Education Status, Employment Status, and hearing status of subjects with NF2
Description
This questionnaire asks subjects with NF2 to report their date of birth, age, gender, race, ethnicity, marital status, highest level of education, hearing status, and primary employment status over the last 12 months.
Time Frame
Baseline (week 0)
Title
Credibility Questionnaire
Description
Measures how much the participant believes the intervention will work.
Time Frame
Baseline (week 0)
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
Measures how satisfied the participant is with the intervention.
Time Frame
Post-intervention (week 8)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana-Maria Vranceanu, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Resiliency Training for Patients With NF2 Via Videoconferencing With Skype
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