Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing

Mass General Brigham

Status: Completed

Conditions: Neurofibromatosis 1; Schwannomatosis; Neurofibromatoses; Neurofibromatosis 2

Treatments: Behavioral: Stress and Symptom Management Program 2; Behavioral: Stress and Symptom Management Program 1

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03406208

W81XWH-17-1-0121 (Other Grant/Funding Number)

2017P000143

Details and patient eligibility

About

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.

Full 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.

Enrollment: 228 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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228 participants in 2 patient groups

Stress and Symptom Management Program 1

Experimental group

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.

Treatment:

Behavioral: Stress and Symptom Management Program 1

Stress and Symptom Management Program 2

Experimental group

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.

Treatment:

Behavioral: Stress and Symptom Management Program 2