NeurofibromatosesNCT02387177
Resiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype
A study testing Stress Management Group 1 and Stress Management Group 2 in people with Neurofibromatoses, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The aim of this research is to adapt the NF-specific adult version of the Skype 3RP for use with adolescents, and to test its feasibility, acceptability, and preliminary effect in improving quality of life, and in decreasing stress and psychological distress. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurofibromatoses
- 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
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2017
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Must be between the ages of 12 and 17
- Can read and speak English at or above the 6th grade level
- Diagnosis of neurofibromatosis type 1 or neurofibromatosis type 2 by a specialized medical provider
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 participate in an intervention delivered via videoconferencing with Skype
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The aim of this research is to adapt the NF-specific adult version of the Skype 3RP for use with adolescents, and to test its feasibility, acceptability, and preliminary effect in improving quality of life, and in decreasing stress and psychological distress.
- Conditions
- Neurofibromatoses
- Being tested
- Stress Management Group 1, Stress Management Group 2
- Medical subject headings
- Neurofibromatoses
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 (WHO-QOLBREFadol)
Measures quality of life
Measured: Change between Baseline (week0), Post-intervention (Week8) and Follow Up (Week 36)
Secondary outcomes (15)
Perceived Stress Scale (PSS-10)
Situations in one's life over the past month/week are appraised as stressful
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
The Pain Catastrophizing Scale - Child Version (PCS-C)
Measures how individuals experience pain
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Patient Health Questionnaire for Adolescents (PHQ-A)
Symptoms of depression and functional impairment
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Pain Interference Index (PII)
How much pain has interfered with their life
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Child and Adolescent Mindfulness Measure (CAMM)
Assesses mindfulness in children and adolescents
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Interpersonal Reactivity Index (IRI)
Assesses the cognitive and affective dimensions of empathy
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Epworth Sleepiness Scale-Revised for Children (ESS)
Measures how likely one is to doze off or sleep in certain situations
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Gratitude Questionnaire Six-Item Form (GQ-6)
Assesses individual differences in the proneness to experience gratitude in daily life
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Life Orientation Test (LOT) Optimism Scale
Individual differences in generalized optimism versus pessimism
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being Scale (FACIT-Sp)
Spiritual well-being (sense of meaning in life and the sense of strength in one's faith) over the past 7 days
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
MOS (Support/Empathy)
Measures recent thinking about the various dimensions of social support.
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Measure of Current Status (MOCS) Part A
Measures participants' current self-perceived status on several skills that are targeted by the intervention: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed.
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Generalized Anxiety Disorder 7-item (GAD-7) scale
A brief measure for assessing generalized anxiety disorder
Measured: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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)
Satisfaction with life adolescent
measures global satisfaction with life
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 posted12 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurofibromatosesStudies 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
- 51 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-Maira Vranceanu, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387177
- Sponsor's protocol ID
- 2014P000702
- Status last verified
- Aug 2018
- First submitted
- 25 Feb 2015
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
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 Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype
- ClinicalTrials.gov ID
- NCT02387177
- Acronym / sponsor ID
- 2014P000702
- Conditions
- Neurofibromatoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- The Children's Tumor Foundation
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 Mar 2015 (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 research is to adapt the NF-specific adult version of the Skype 3RP for use with adolescents, and to test its feasibility, acceptability, and preliminary effect in improving quality of life, and in decreasing stress and psychological distress.
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
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Must be between the ages of 12 and 17
- Can read and speak English at or above the 6th grade level
- Diagnosis of neurofibromatosis type 1 or neurofibromatosis type 2 by a specialized medical provider
Key exclusion criteria (5 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 participate in an intervention delivered via videoconferencing with Skype
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 (WHO-QOLBREFadol)
Time frame: Change between Baseline (week0), Post-intervention (Week8) and Follow Up (Week 36)
Measures quality of life
15 secondary outcomes
Perceived Stress Scale (PSS-10)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
The Pain Catastrophizing Scale - Child Version (PCS-C)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Patient Health Questionnaire for Adolescents (PHQ-A)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Pain Interference Index (PII)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Child and Adolescent Mindfulness Measure (CAMM)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Interpersonal Reactivity Index (IRI)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Epworth Sleepiness Scale-Revised for Children (ESS)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Gratitude Questionnaire Six-Item Form (GQ-6)
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)
Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being Scale (FACIT-Sp)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
MOS (Support/Empathy)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Measure of Current Status (MOCS) Part A
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Generalized Anxiety Disorder 7-item (GAD-7) scale
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Quality of Life (WHOQOL-BREF)
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Satisfaction with life adolescent
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.
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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-Maira 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 Neurofibromatoses, 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 5 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 (WHO-QOLBREFadol) (time frame: Change between Baseline (week0), Post-intervention (Week8) and Follow Up (Week 36)). 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.