Neurofibromatosis 2NCT02811718
Resiliency Training for Patients With NF2 Via Videoconferencing With Skype
A study testing Stress Management Group 1 and Stress Management Group 2 in people with Neurofibromatosis 2, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurofibromatosis 2
- What is being tested?
- Stress Management Group 1 and Stress Management Group 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype
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
- Being tested
- Stress Management Group 1, Stress Management Group 2
- Keywords
- Stress Management, Resiliency, Skype
- Medical subject headings
- Neurofibromatosis 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Management Group 1Behavioural
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
Stress Management Group 2Behavioural
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Stress Management Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
The 14-Item Resiliency Scale (RS-14)
The RS-14 measures stress coping ability in the face of adversity.
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Patient Health Questionnaire (PHQ)
The PHQ measures symptoms of depression and functional impairment.
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Cognitive and Affective Mindfulness Scale (CAMS)
The CAMS measures the degree to which individuals experience their thoughts and feelings.
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Life Orientation Test (LOT) Optimism Scale
The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism.
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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.
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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.
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Medical Outcomes Study (MOS) Social Support Survey
The MOS Social Support Survey measures various dimensions of social support.
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurofibromatosis 2Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Children's Tumor Foundation
- Responsible party
- Principal investigator, Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
- Investigators
- Ana-Maria Vranceanu, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811718
- Sponsor's protocol ID
- 2013P002605b
- Status last verified
- Aug 2018
- First submitted
- 21 Jun 2016
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype
- ClinicalTrials.gov ID
- NCT02811718
- Acronym / sponsor ID
- 2013P002605b
- Conditions
- Neurofibromatosis 2
- Keywords
- Stress Management, Resiliency, Skype
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- The Children's Tumor Foundation
- Study start
- Jul 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress Management Group 1 | Experimental | Behavioral: Stress Management Group 1Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques. |
| Stress Management Group 2 | Experimental | Behavioral: Stress Management Group 2Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress Management Group 1Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques. | Behavioural | Stress Management Group 1 |
| Stress Management Group 2Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques. | Behavioural | Stress Management Group 2 |
Primary outcome
Quality of Life (WHOQOL-BREF)
Time frame: 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.
Penn Acoustic Neuroma Quality-of Life Scale (PANQOL)
Time frame: 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.
8 secondary outcomes
Perceived Stress Scale (PSS-10)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
The 14-Item Resiliency Scale (RS-14)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Patient Health Questionnaire (PHQ)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Cognitive and Affective Mindfulness Scale (CAMS)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Life Orientation Test (LOT) Optimism Scale
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
The Gratitude Questionnaire (GQ-6)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Measure of Current Status (MOCS-A)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Medical Outcomes Study (MOS) Social Support Survey
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana-Maria Vranceanu, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Management Group 1 and Stress Management Group 2 in people with Neurofibromatosis 2, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (WHOQOL-BREF) (time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32 and week 64)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.