Resiliency Training for Patients With NF2 Via Videoconferencing With Skype

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stress Management Group 1

Stress Management Group 2

About this trial

This is an interventional treatment trial for Neurofibromatosis 2 focused on measuring Stress Management, Resiliency, Skype

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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.

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