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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • 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 names:
    • SMP2

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Ana-Maria Vranceanu, PhD
617-643-7996
avranceanu@mgh.harvard.edu

More Details

Status
Unknown status
Sponsor
Massachusetts General Hospital

Study Contact

Ana-Maria Vranceanu, PhD
6176437996
avranceanu@mgh.harvard.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.