Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing

NCT03406208 | Completed

• 2 other identifiers: 2017P000143W81XWH-17-1-0121
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schwannomatosis; Neurofibromatoses; Neurofibromatosis 1; Neurofibromatosis 2

Keywords

Psychiatry; Psychology; Psychosocial; Behavioral

Outcome Measures

Primary Outcomes (2)

• Change in Physical Quality of Life

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

  0 Weeks, 8 Weeks, 6 Months, 12 Months

• Change in Psychological Quality of Life

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

  0 Weeks, 8 Weeks, 6 Months, 12 Months

Secondary Outcomes (13)

• Social Quality of Life

  0 Weeks, 8 Weeks, 6 Months, 12 Months

• Environmental Quality of Life

  0 Weeks, 8 Weeks, 6 Months, 12 Months

• Depression

  0 Weeks, 8 Weeks, 6 Months, 12 Months

• Anxiety

  0 Weeks, 8 Weeks, 6 Months, 12 Months

• Social Support

  0 Weeks, 8 Weeks, 6 Months, 12 Months

Study Arms (2)

Stress and Symptom Management Program 1

EXPERIMENTAL

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

Stress and Symptom Management Program 2

EXPERIMENTAL

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

Stress and Symptom Management Program 2 BEHAVIORAL

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

Stress and Symptom Management Program 2

Stress and Symptom Management Program 1 BEHAVIORAL

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

Stress and Symptom Management Program 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has a diagnosis of NF1, NF2, or Schwannomatosis
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• United States Department of Defense: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (12)

• 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.

  PMID: 40773151 DERIVED

• 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.

  PMID: 39917761 DERIVED

• 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.

  PMID: 38318960 DERIVED

• 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.

  PMID: 37440099 DERIVED

• 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.

  PMID: 37378983 DERIVED

• 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.

  PMID: 36651958 DERIVED

• 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.

  PMID: 35925531 DERIVED

• 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.

  PMID: 35064449 DERIVED

• 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.

  PMID: 34570301 DERIVED

• 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.

  PMID: 34409538 DERIVED

• 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.

  PMID: 32421171 DERIVED

• 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.

  PMID: 30355560 DERIVED

MeSH Terms

Conditions

Neurofibromatoses; Neurofibromatosis 1; Neurofibromatosis 2; Schwannomatosis; Behavior

Condition Hierarchy (Ancestors)

Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neuroma, Acoustic; Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neuroma; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Neoplasms; Cranial Nerve Diseases

Study Officials

• Ana-Maria Vranceanu, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: January 23, 2018
• Study Start: October 1, 2017
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)