CClinicalTrials.gg
CompletedNCT03406208Updated Dec 24, 2025

Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing

An interventional study of Stress and Symptom Management Program 1 and Stress and Symptom Management Program 2 in Neurofibromatoses, Neurofibromatosis 1 and Neurofibromatosis 2, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
228
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Neurofibromatoses
  • Neurofibromatosis 1
  • Neurofibromatosis 2
  • Schwannomatosis

Keywords

  • Psychiatry
  • Psychology
  • Psychosocial
  • Behavioral
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
228 participants (actual)

Study arms

  • Experimental
    Stress and Symptom Management Program 1

    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.

    Behavioral: Stress and Symptom Management Program 1

  • Experimental
    Stress and Symptom Management Program 2

    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.

    Behavioral: Stress and Symptom Management Program 2

Interventions

  • BehavioralStress and Symptom Management Program 1

    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.

    Also known as: SMP2

  • BehavioralStress and Symptom Management Program 2

    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.

    Also known as: SMP2

05

What researchers measure

Primary outcomes

  1. Change in Physical Quality of Life

    World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL

    Time frame: 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

    Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months

Secondary outcomes

  1. Social Quality of Life

    World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months

  6. Gratitude

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

    Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months

  7. Optimism

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

    Time frame: 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

    Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months

  9. Mindfulness

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

    Time frame: 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

    Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months

  11. Pain Intensity

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

    Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months

  12. Pain Interference

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

    Time frame: 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

    Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months

06

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
07

References and documents

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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03406208
Lead sponsor
Massachusetts General Hospital
Collaborators
United States Department of Defense
Responsible party
Ana-Maria Vranceanu, PhD (Clinical Psychologist, Massachusetts General Hospital) — Principal investigator
First posted
Jan 23, 2018
Start date
Oct 1, 2017
Primary completion
Feb 28, 2022
Completion
Feb 28, 2022
Last update
Dec 24, 2025

Study contacts

Ana-Maria Vranceanu, PhD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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