NeurofibromatosesNCT03873610
Resiliency Training in Adolescents With NF1 and NF2
A study testing Stress and Symptom Management Program 1 and Stress and Symptom Management Program 2 in people with Neurofibromatoses, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This randomized controlled trial for resiliency training in adolescents with Neurofibromatosis 1 and Neurofibromatosis 2 via secure live video to determine the efficacy two stress and symptom management programs. Both programs are 8 week group programs. 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 and Symptom Management Program 1 and Stress and Symptom Management Program 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2019to 20 Feb 2026
- 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
- Has a diagnosis of NF1 or NF2 and is between the ages of 12-17
- Is capable of completing and fully understanding the informed consent process/assent and the study procedures and assessments in English; has parental approval for participation
- English speaking and at least a 3rd grade self-reported and parent reported reading level
- Self reported/parent reported difficulties coping with stress and NF symptoms
Who cannot join
- Has major medical co-morbidity not NF related expected to worsen in the next 12 months
- Recent (within past 3 months) change in antidepressant medication
- Recent participation in cognitive behavioral therapy or relaxation therapy (within past 3 months)
- Has significant mental health diagnosis requiring immediate treatment (e.g., untreated bipolar disorder, psychotic disorder, active substance dependence)
- Unable or unwilling to complete assessments electronically via REDCap
- Unable or unwilling to participate in group videoconferencing sessions
- Unable or unwilling to participate along with at least 1 parent in a video screening session
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02140
About this study
Official title: Resiliency Training in Adolescents With NF1 and NF2; A Randomized Controlled Trial Via Secure Live Video Conferencing to Improve Emotional, Social and Physical Function
This randomized controlled trial for resiliency training in adolescents with Neurofibromatosis 1 and Neurofibromatosis 2 via secure live video to determine the efficacy two stress and symptom management programs. Both programs are 8 week group programs.
Read the detailed description
Neurofibromatosis (NFs) are rare genetic conditions with cure. Adolescents with NF experience more symptoms of depression and anxiety, higher levels of stress associated with coping with NF symptoms, lower levels of self esteem, difficulties with social skills and social support, high rates of learning disabilities, and more pain as compared with the general population norms.
The aims of this study are to compare the effect of two stress and symptom management programs tailored for adolescents with neurofibromatosis on quality of life and psychosocial functioning. We will also examine the degree to which treatment-dependent improvements in quality of life are mediated by improvements in depression, pain intensity and pain interference.
- Conditions
- Neurofibromatoses
- Being tested
- Stress and Symptom Management Program 1, Stress and Symptom Management Program 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 and Symptom Management Program 1Behavioural
The Stress and Symptom Management Program 1 introduces and reinforces stress and symptom management for adolescents with NF. The program consists of 8 weekly 45 minute sessions, delivered through videoconferencing.
Stress and Symptom Management Program 2Behavioural
The Stress and Symptom Management Program 2 introduces and reinforces stress and symptom management for adolescents with NF. The program consists of 8 weekly 45 minute sessions, delivered through videoconferencing.
| Study group | Role | What they receive |
|---|---|---|
| Stress and Symptom Management Program 1 | Experimental | Not described Receives: Behavioral: Stress and Symptom Management Program 1 |
| Stress and Symptom Management 2 | Experimental | Not described Receives: Behavioral: Stress and Symptom Management Program 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Health Quality of Life
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL
Measured: 0 weeks, 8 weeks, 6 months,12 months
Change in Psychological Health Quality of Life
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL
Measured: 0 weeks, 8 weeks, 6 months,12 months
Secondary outcomes (6)
Social relationships Quality of Life
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL
Measured: 0 weeks, 8 weeks, 6 months,12 months
Environmental Quality of Life
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL
Measured: 0 weeks, 8 weeks, 6 months, 12 months
Depression
Patient Health Questionnaire (PHQ-9) Adolescent Version; 0-27; Higher score indicates more symptoms of depression
Measured: 0 weeks, 8 weeks, 6 months, 12 months
Anxiety
Generalized Anxiety Disorder (GAD-7) Questionnaire; 0-21; Higher score indicates more symptoms of anxiety
Measured: 0 weeks, 8 weeks, 6 months, 12 months
Pain intensity
Numerical Rating Scale; 0-10; Higher score indicates more intense pain.
Measured: 0 weeks, 8 weeks, 6 months, 12 months
Pain interference
Pain Interference Index (PII); 0-36; Higher score indicates more pain interference
Measured: 0 weeks, 8 weeks, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start15 Dec 2019
- Primary completion20 Feb 2026
- Study completion20 Feb 2026
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- 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
- NCT03873610
- Sponsor's protocol ID
- 2019P000625
- Status last verified
- Jun 2026
- First submitted
- 12 Mar 2019
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resiliency Training in Adolescents With NF1 and NF2; A Randomized Controlled Trial Via Secure Live Video Conferencing to Improve Emotional, Social and Physical Function
- ClinicalTrials.gov ID
- NCT03873610
- Acronym / sponsor ID
- 2019P000625
- Conditions
- Neurofibromatoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 13 Mar 2019 (actual)
- 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.
This randomized controlled trial for resiliency training in adolescents with Neurofibromatosis 1 and Neurofibromatosis 2 via secure live video to determine the efficacy two stress and symptom management programs. Both programs are 8 week group programs.
Detailed description
Neurofibromatosis (NFs) are rare genetic conditions with cure. Adolescents with NF experience more symptoms of depression and anxiety, higher levels of stress associated with coping with NF symptoms, lower levels of self esteem, difficulties with social skills and social support, high rates of learning disabilities, and more pain as compared with the general population norms.
The aims of this study are to compare the effect of two stress and symptom management programs tailored for adolescents with neurofibromatosis on quality of life and psychosocial functioning. We will also examine the degree to which treatment-dependent improvements in quality of life are mediated by improvements in depression, pain intensity and pain interference.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress and Symptom Management Program 1 | Experimental | Behavioral: Stress and Symptom Management Program 1 |
| Stress and Symptom Management 2 | Experimental | Behavioral: Stress and Symptom Management Program 2 |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Has a diagnosis of NF1 or NF2 and is between the ages of 12-17
- Is capable of completing and fully understanding the informed consent process/assent and the study procedures and assessments in English; has parental approval for participation
- English speaking and at least a 3rd grade self-reported and parent reported reading level
- Self reported/parent reported difficulties coping with stress and NF symptoms
Key exclusion criteria (7 listed)
- Has major medical co-morbidity not NF related expected to worsen in the next 12 months
- Recent (within past 3 months) change in antidepressant medication
- Recent participation in cognitive behavioral therapy or relaxation therapy (within past 3 months)
- Has significant mental health diagnosis requiring immediate treatment (e.g., untreated bipolar disorder, psychotic disorder, active substance dependence)
- Unable or unwilling to complete assessments electronically via REDCap
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 and Symptom Management Program 1The Stress and Symptom Management Program 1 introduces and reinforces stress and symptom management for adolescents with NF. The program consists of 8 weekly 45 minute sessions, delivered through videoconferencing. | Behavioural | Stress and Symptom Management Program 1 |
| Stress and Symptom Management Program 2The Stress and Symptom Management Program 2 introduces and reinforces stress and symptom management for adolescents with NF. The program consists of 8 weekly 45 minute sessions, delivered through videoconferencing. | Behavioural | Stress and Symptom Management 2 |
Primary outcome
Change in Physical Health Quality of Life
Time frame: 0 weeks, 8 weeks, 6 months,12 months
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL
Change in Psychological Health Quality of Life
Time frame: 0 weeks, 8 weeks, 6 months,12 months
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; Higher score indicates higher QoL
6 secondary outcomes
Social relationships Quality of Life
Time frame: 0 weeks, 8 weeks, 6 months,12 months
Environmental Quality of Life
Time frame: 0 weeks, 8 weeks, 6 months, 12 months
Depression
Time frame: 0 weeks, 8 weeks, 6 months, 12 months
Anxiety
Time frame: 0 weeks, 8 weeks, 6 months, 12 months
Pain intensity
Time frame: 0 weeks, 8 weeks, 6 months, 12 months
Pain interference
Time frame: 0 weeks, 8 weeks, 6 months, 12 months
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 11 Jun 2026.
- Individual participant dataSharing planned: No
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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 and Symptom Management Program 1 and Stress and Symptom Management Program 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 4 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 11 Jun 2026. 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?
Change in Physical Health Quality of Life (time frame: 0 weeks, 8 weeks, 6 months,12 months). 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 11 Jun 2026.