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Completed

NCT Number: NCT03406208

Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing

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.

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Key information

Conditions

Neurofibromatoses Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Cranial Nerve Neoplasms Ear Diseases Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplastic Syndromes, Hereditary Nerve Sheath Neoplasms Nervous System Diseases Neurilemmoma Neurocutaneous Syndromes Neurodegenerative Diseases Neuroectodermal Tumors Neuroendocrine Tumors Neurofibroma Neurofibromatosis 1 Neurofibromatosis 2 Neuroma Neuroma, Acoustic Neuromuscular Diseases Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Peripheral Nervous System Diseases Retrocochlear Diseases Schwannomatosis Vestibulocochlear Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: SMP2

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.

Other names: SMP2

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jan 23, 2018
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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