Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing
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ClinicalTrials.gov Identifier: NCT03406208 |
Recruitment Status :
Recruiting
First Posted : January 23, 2018
Last Update Posted : September 8, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neurofibromatoses Neurofibromatosis 1 Neurofibromatosis 2 Schwannomatosis | Behavioral: Stress and Symptom Management Program 1 Behavioral: Stress and Symptom Management Program 2 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 224 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing |
Actual Study Start Date : | October 1, 2017 |
Estimated Primary Completion Date : | January 30, 2022 |
Estimated Study Completion Date : | January 30, 2022 |

Arm | Intervention/treatment |
---|---|
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.
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Behavioral: 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.
Other Name: SMP2 |
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
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.
Other Name: SMP2 |
- Change in Physical 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 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
- Social 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
- Environmental 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
- Depression [ Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months ]Patient Health Questionnaire 9-Item (PHQ-9); 0-27; higher score indicates more symptoms of depression
- Anxiety [ Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months ]Generalized Anxiety Disorder 7-Item (GAD-7); 0-21; higher score indicates more symptoms of anxiety
- Social Support [ Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months ]Medical Outcome Study Social Support Survey (MOS); 18-90; higher scores indicate greater perceived social support
- Gratitude [ Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months ]Gratitude Questionnaire 6-Item (GQ-6); 6-42; higher scores indicate greater gratitude
- Optimism [ Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months ]Life Orientation Test-Revised (LOT-R); 0-40; higher scores indicate greater optimism
- Coping Strategies [ Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months ]Measure of Current Status Part A (MOCS-A); 0-52; higher scores indicate greater perceived ability to cope
- Mindfulness [ Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months ]Cognitive and Affective Mindfulness Scale (CAMS); 10-40; higher scores indicate greater mindfulness
- Empathy [ Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months ]Interpersonal Reactivity Index (IRI) Empathy Subscale; 7-Items; 0-28; higher scores indicate greater empathy
- Pain Intensity [ Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months ]Graded Chronic Pain Scale (GCPS); 0-100; higher scores indicate greater pain intensity
- Pain Interference [ Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months ]PROMIS Pain Interference; 8-40; higher scores indicate more pain interference
- Stress [ Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months ]Perceived Stress Scale 10-Item (PSS-10); 0-21; higher scores indicate greater levels of perceived stress

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03406208
Contact: Ana-Maria Vranceanu, PhD | 6176437996 | avranceanu@mgh.harvard.edu | |
Contact: Christopher J Funes, MS | 6176431168 | cjfunes@mgh.harvard.edu |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Ana-Maria Vranceanu, PhD 617-643-7996 avranceanu@mgh.harvard.edu | |
Contact: Christopher J Funes, MS 6176431168 cjfunes@mgh.harvard.edu |
Principal Investigator: | Ana-Maria Vranceanu, PhD | Massachusetts General Hospital |
Responsible Party: | Ana-Maria Vranceanu, PhD, Clinical Psychologist, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT03406208 |
Other Study ID Numbers: |
2017P000143 |
First Posted: | January 23, 2018 Key Record Dates |
Last Update Posted: | September 8, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Psychiatry Psychology Psychosocial Behavioral |
Neurofibromatoses Neurofibromatosis 1 Neurofibroma Neurofibromatosis 2 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 Peripheral Nervous System Diseases |
Neuromuscular Diseases Peripheral Nervous System Neoplasms Nervous System Neoplasms 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 |