Clinical trial · Interventional
Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing
NCT03406208CI-TRIAL-00099644completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neurofibromatoses | — | UNRESOLVED | — |
| Neurofibromatosis 1 | — | UNRESOLVED | — |
| Neurofibromatosis 2 | — | UNRESOLVED | — |
| Schwannomatosis | Schwannomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stress and Symptom Management Program 1 | Behavioral | — | UNRESOLVED |
| Stress and Symptom Management Program 2 | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stress and Symptom Management Program 1
- description
- 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.
- interventionNames
- Behavioral: Stress and Symptom Management Program 1
- type
- EXPERIMENTAL
- label
- Stress and Symptom Management Program 2
- description
- 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.
- interventionNames
- Behavioral: Stress and Symptom Management Program 2
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: * 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
References
Publications (12)
- DERIVEDBrewer 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
- DERIVEDHooker 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
- DERIVEDMcDermott 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
- DERIVEDPresciutti 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
- DERIVEDVranceanu 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
- DERIVEDLester 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.