Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing

Neurofibromatosis 1 Clinical Trial

Official title:

Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03406208
• Other study ID #: 2017P000143
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: January 30, 2022

Study information

• Verified date: September 2021
• Source: Massachusetts General Hospital
• Contact: Ana-Maria Vranceanu, PhD
• Phone: 6176437996
• Email: avranceanu[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: January 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis 1
• Neurofibromatosis 2
• Schwannomatosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Physical Quality of Life	World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL	0 Weeks, 8 Weeks, 6 Months, 12 Months
Primary	Change in Psychological Quality of Life	World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL	0 Weeks, 8 Weeks, 6 Months, 12 Months
Secondary	Social Quality of Life	World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL	0 Weeks, 8 Weeks, 6 Months, 12 Months
Secondary	Environmental Quality of Life	World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL	0 Weeks, 8 Weeks, 6 Months, 12 Months
Secondary	Depression	Patient Health Questionnaire 9-Item (PHQ-9); 0-27; higher score indicates more symptoms of depression	0 Weeks, 8 Weeks, 6 Months, 12 Months
Secondary	Anxiety	Generalized Anxiety Disorder 7-Item (GAD-7); 0-21; higher score indicates more symptoms of anxiety	0 Weeks, 8 Weeks, 6 Months, 12 Months
Secondary	Social Support	Medical Outcome Study Social Support Survey (MOS); 18-90; higher scores indicate greater perceived social support	0 Weeks, 8 Weeks, 6 Months, 12 Months
Secondary	Gratitude	Gratitude Questionnaire 6-Item (GQ-6); 6-42; higher scores indicate greater gratitude	0 Weeks, 8 Weeks, 6 Months, 12 Months
Secondary	Optimism	Life Orientation Test-Revised (LOT-R); 0-40; higher scores indicate greater optimism	0 Weeks, 8 Weeks, 6 Months, 12 Months
Secondary	Coping Strategies	Measure of Current Status Part A (MOCS-A); 0-52; higher scores indicate greater perceived ability to cope	0 Weeks, 8 Weeks, 6 Months, 12 Months
Secondary	Mindfulness	Cognitive and Affective Mindfulness Scale (CAMS); 10-40; higher scores indicate greater mindfulness	0 Weeks, 8 Weeks, 6 Months, 12 Months
Secondary	Empathy	Interpersonal Reactivity Index (IRI) Empathy Subscale; 7-Items; 0-28; higher scores indicate greater empathy	0 Weeks, 8 Weeks, 6 Months, 12 Months
Secondary	Pain Intensity	Graded Chronic Pain Scale (GCPS); 0-100; higher scores indicate greater pain intensity	0 Weeks, 8 Weeks, 6 Months, 12 Months
Secondary	Pain Interference	PROMIS Pain Interference; 8-40; higher scores indicate more pain interference	0 Weeks, 8 Weeks, 6 Months, 12 Months
Secondary	Stress	Perceived Stress Scale 10-Item (PSS-10); 0-21; higher scores indicate greater levels of perceived stress	0 Weeks, 8 Weeks, 6 Months, 12 Months