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NeurofibromatosesNCT03406208

Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing

A study testing Stress and Symptom Management Program 1 and Stress and Symptom Management Program 2 in people with Neurofibromatoses and Neurofibromatosis 1, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aims of this study are to compare the effect and durability of two stress and symptom management programs tailored for patients with neurofibromatosis on quality of life and psychosocial functioning. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Stress and Symptom Management Program 1 and Stress and Symptom Management Program 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
1 siteUnited States
Study dates
1 Oct 2017to 28 Feb 2022
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

  • Has a diagnosis of NF1, NF2, or Schwannomatosis
  • 18 years of age or older
  • Is capable of completing and fully understanding the informed consent process, study procedures, and study assessments in English
  • At least 6th grade self-reported reading level
  • Self-reported difficulties coping with stress and NF-symptoms
  • Score of 6 or higher on Perceived Stress Scale 4-Item (PSS-4)

Who cannot join

  • Has major medical comorbidity not NF related expected to worsen in the next 12 months
  • Recent (within past 3 months) change in antidepressant medication
  • Recent (within past 3 months) participation in cognitive behavioral therapy or relaxation therapy
  • Has significant mental health diagnosis requiring immediate treatment (e.g., bipolar disorder, psychotic disorder, active substance use dependence)
  • Unable or unwilling to complete assessments electronically via REDCap
  • Unable or unwilling to participate in group videoconferencing sessions

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

The aims of this study are to compare the effect and durability of two stress and symptom management programs tailored for patients with neurofibromatosis on quality of life and psychosocial functioning.

Read the detailed description

The aims of this study are to compare the effect of two stress and symptom management programs tailored for patients 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, anxiety, distress, mindfulness, gratitude, social support, empathy, optimism, coping, pain intensity and pain interference.

Being tested
Stress and Symptom Management Program 1, Stress and Symptom Management Program 2
Keywords
Psychiatry, Psychology, Psychosocial, Behavioral
Medical subject headings
Neurofibromatoses, Neurofibromatosis 1, Neurofibromatosis 2, Schwannomatosis, Behavior

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

    Also called SMP2

    The Stress and Symptom Management Program 1 (SMP1) introduces and reinforces stress and symptom management skills. The program consists of 8 weekly sessions (90 minutes each), delivered through live videoconferencing.

  • Stress and Symptom Management Program 2Behavioural

    Also called SMP2

    The Stress and Symptom Management Program 2 (SMP2) introduces and reinforces stress and symptom management skills. The program consists of 8 weekly sessions (90 minutes each), delivered through live videoconferencing.

Study groups in NCT03406208
Study groupRoleWhat they receive
Stress and Symptom Management Program 1ExperimentalThe Stress and Symptom Management Program 1 (SMP1) introduces and reinforces stress and symptom management skills. The program consists of 8 weekly sessions (90 minutes each), delivered through live videoconferencing.
Receives: Behavioral: Stress and Symptom Management Program 1
Stress and Symptom Management Program 2ExperimentalThe Stress and Symptom Management Program 2 (SMP2) introduces and reinforces stress and symptom management skills. The program consists of 8 weekly sessions (90 minutes each), delivered through live videoconferencing.
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.

  1. Change in Physical 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

  2. Change in Psychological 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 (13)

  1. Social 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

  2. 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

  3. Depression

    Patient Health Questionnaire 9-Item (PHQ-9); 0-27; higher score indicates more symptoms of depression

    Measured: 0 Weeks, 8 Weeks, 6 Months, 12 Months

  4. Anxiety

    Generalized Anxiety Disorder 7-Item (GAD-7); 0-21; higher score indicates more symptoms of anxiety

    Measured: 0 Weeks, 8 Weeks, 6 Months, 12 Months

  5. Social Support

    Medical Outcome Study Social Support Survey (MOS); 18-90; higher scores indicate greater perceived social support

    Measured: 0 Weeks, 8 Weeks, 6 Months, 12 Months

  6. Gratitude

    Gratitude Questionnaire 6-Item (GQ-6); 6-42; higher scores indicate greater gratitude

    Measured: 0 Weeks, 8 Weeks, 6 Months, 12 Months

  7. Optimism

    Life Orientation Test-Revised (LOT-R); 0-40; higher scores indicate greater optimism

    Measured: 0 Weeks, 8 Weeks, 6 Months, 12 Months

  8. Coping Strategies

    Measure of Current Status Part A (MOCS-A); 0-52; higher scores indicate greater perceived ability to cope

    Measured: 0 Weeks, 8 Weeks, 6 Months, 12 Months

  9. Mindfulness

    Cognitive and Affective Mindfulness Scale (CAMS); 10-40; higher scores indicate greater mindfulness

    Measured: 0 Weeks, 8 Weeks, 6 Months, 12 Months

  10. Empathy

    Interpersonal Reactivity Index (IRI) Empathy Subscale; 7-Items; 0-28; higher scores indicate greater empathy

    Measured: 0 Weeks, 8 Weeks, 6 Months, 12 Months

  11. Pain Intensity

    Graded Chronic Pain Scale (GCPS); 0-100; higher scores indicate greater pain intensity

    Measured: 0 Weeks, 8 Weeks, 6 Months, 12 Months

  12. Pain Interference

    PROMIS Pain Interference; 8-40; higher scores indicate more pain interference

    Measured: 0 Weeks, 8 Weeks, 6 Months, 12 Months

  13. Stress

    Perceived Stress Scale 10-Item (PSS-10); 0-21; higher scores indicate greater levels of perceived stress

    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.

  1. First posted23 Jan 2018
  2. Study start1 Oct 2017
  3. Primary completion28 Feb 2022
  4. Study completion28 Feb 2022

Resources

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
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03406208
Sponsor's protocol ID
2017P000143
Other IDs
W81XWH-17-1-0121
Status last verified
Dec 2025
First submitted
6 Dec 2017
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brewer JR, Hooker JE, Kanaya M, LaCamera DE, Bakhshaie J, Vranceanu AM. Social support moderates quality of life outcomes during a mind-body intervention among adults with neurofibromatosis. J Neurooncol. 2025 Oct;175(1):133-141. doi: 10.1007/s11060-025-05108-8. Epub 2025 Aug 7.

    PubMed 40773151

  • Hooker JE, Doorley JD, Greenberg J, Bakhshaie J, Manglani HR, Briskin EA, Vranceanu AM. Improvements in pain interference among geographically diverse adults with neurofibromatosis: Results from a fully powered randomized controlled trial. Neurooncol Pract. 2024 Sep 20;12(1):58-67. doi: 10.1093/nop/npae084. eCollection 2025 Feb.

    PubMed 39917761

  • McDermott K, Bakhshaie J, Brewer J, Vranceanu AM. The impact of a virtual mind-body program on symptoms of depression and anxiety among international English-speaking adults with neurofibromatosis. Am J Med Genet A. 2024 Jun;194(6):e63543. doi: 10.1002/ajmg.a.63543. Epub 2024 Feb 6.

    PubMed 38318960

  • Presciutti AM, Lester EG, Woodworth EC, Greenberg J, Bakhshaie J, Hooker JE, McDermott KA, Vranceanu AM. The impact of a virtual mind-body program on resilience factors among international English-speaking adults with neurofibromatoses: secondary analysis of a randomized clinical trial. J Neurooncol. 2023 Jul;163(3):707-716. doi: 10.1007/s11060-023-04389-1. Epub 2023 Jul 13.

    PubMed 37440099

  • Vranceanu AM, Manglani HR, Choukas NR, Kanaya MR, Lester E, Zale EL, Plotkin SR, Jordan J, Macklin E, Bakhshaie J. Effect of Mind-Body Skills Training on Quality of Life for Geographically Diverse Adults With Neurofibromatosis: A Fully Remote Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2320599. doi: 10.1001/jamanetworkopen.2023.20599.

    PubMed 37378983

  • Lester EG, Wang KE, Blakeley JO, Vranceanu AM. Occurrence and Severity of Suicidal Ideation in Adults With Neurofibromatosis Participating in a Mind-Body RCT. Cogn Behav Neurol. 2023 Mar 1;36(1):19-27. doi: 10.1097/WNN.0000000000000332.

    PubMed 36651958

  • Fishbein NS, Vranceanu AM, Mace RA. Baseline characteristics of adults with neurofibromatosis enrolled on a psychosocial randomized controlled trial. J Neurooncol. 2022 Sep;159(3):637-646. doi: 10.1007/s11060-022-04104-6. Epub 2022 Aug 4.

    PubMed 35925531

  • Bannon SM, Hopkins SW, Grunberg VA, Vranceanu AM. Psychosocial profiles of risk and resiliency in neurofibromatoses: a person-centered analysis of illness adaptation. J Neurooncol. 2022 Feb;156(3):519-527. doi: 10.1007/s11060-021-03928-y. Epub 2022 Jan 22.

    PubMed 35064449

  • Mace RA, Doorley J, Bakhshaie J, Cohen JE, Vranceanu AM. Psychological resiliency explains the relationship between emotional distress and quality of life in neurofibromatosis. J Neurooncol. 2021 Nov;155(2):125-132. doi: 10.1007/s11060-021-03852-1. Epub 2021 Sep 27.

    PubMed 34570301

  • Doorley JD, Greenberg J, Bakhshaie J, Fishbein NS, Vranceanu AM. Depression explains the association between pain intensity and pain interference among adults with neurofibromatosis. J Neurooncol. 2021 Sep;154(2):257-263. doi: 10.1007/s11060-021-03826-3. Epub 2021 Aug 19.

    PubMed 34409538

  • Lester EG, Gates MV, Vranceanu AM. Mind-Body Therapy via Videoconferencing in Patients With Neurofibromatosis: Analyses of 1-Year Follow-up. Ann Behav Med. 2021 Feb 12;55(1):77-81. doi: 10.1093/abm/kaaa030.

    PubMed 32421171

  • Vranceanu AM, Zale EL, Funes CJ, Macklin EA, McCurley J, Park ER, Jordan JT, Lin A, Plotkin SR. Mind-Body Treatment for International English-Speaking Adults With Neurofibromatosis via Live Videoconferencing: Protocol for a Single-Blind Randomized Controlled Trial. JMIR Res Protoc. 2018 Oct 23;7(10):e11008. doi: 10.2196/11008.

    PubMed 30355560

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 and Neurofibromatosis 1, 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 6 inclusion and 6 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 24 Dec 2025. 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 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?

On the ClinicalTrials.gov record for NCT03406208, which also lists 12 linked publications.

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 24 Dec 2025.

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