Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03406208
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Ana-Maria Vranceanu, PhD, Massachusetts General Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Gratitude [ Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months ]
    Gratitude Questionnaire 6-Item (GQ-6); 6-42; higher scores indicate greater gratitude

  7. Optimism [ Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months ]
    Life Orientation Test-Revised (LOT-R); 0-40; higher scores indicate greater optimism

  8. 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

  9. Mindfulness [ Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months ]
    Cognitive and Affective Mindfulness Scale (CAMS); 10-40; higher scores indicate greater mindfulness

  10. 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

  11. 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

  12. Pain Interference [ Time Frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months ]
    PROMIS Pain Interference; 8-40; higher scores indicate more pain interference

  13. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Ana-Maria Vranceanu, PhD 6176437996 avranceanu@mgh.harvard.edu
Contact: Christopher J Funes, MS 6176431168 cjfunes@mgh.harvard.edu

Locations
Layout table for location information
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   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Ana-Maria Vranceanu, PhD Massachusetts General Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
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: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana-Maria Vranceanu, PhD, Massachusetts General Hospital:
Psychiatry
Psychology
Psychosocial
Behavioral
Additional relevant MeSH terms:
Layout table for MeSH terms
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