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Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing

Primary Purpose

Neurofibromatoses, Neurofibromatosis 1, Neurofibromatosis 2

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress and Symptom Management Program 1
Stress and Symptom Management Program 2
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurofibromatoses focused on measuring Psychiatry, Psychology, Psychosocial, Behavioral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stress and Symptom Management Program 1

Stress and Symptom Management Program 2

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in Physical Quality of Life
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL
Change in Psychological Quality of Life
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL

Secondary Outcome Measures

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

Full Information

First Posted
December 6, 2017
Last Updated
September 7, 2021
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03406208
Brief Title
Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing
Official Title
Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
January 30, 2022 (Anticipated)
Study Completion Date
January 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurofibromatoses, Neurofibromatosis 1, Neurofibromatosis 2, Schwannomatosis
Keywords
Psychiatry, Psychology, Psychosocial, Behavioral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stress and Symptom Management Program 1
Arm Type
Experimental
Arm 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.
Arm Title
Stress and Symptom Management Program 2
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Stress and Symptom Management Program 1
Other Intervention Name(s)
SMP2
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Stress and Symptom Management Program 2
Other Intervention Name(s)
SMP2
Intervention 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.
Primary Outcome Measure Information:
Title
Change in Physical Quality of Life
Description
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL
Time Frame
0 Weeks, 8 Weeks, 6 Months, 12 Months
Title
Change in Psychological Quality of Life
Description
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL
Time Frame
0 Weeks, 8 Weeks, 6 Months, 12 Months
Secondary Outcome Measure Information:
Title
Social Quality of Life
Description
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL
Time Frame
0 Weeks, 8 Weeks, 6 Months, 12 Months
Title
Environmental Quality of Life
Description
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL
Time Frame
0 Weeks, 8 Weeks, 6 Months, 12 Months
Title
Depression
Description
Patient Health Questionnaire 9-Item (PHQ-9); 0-27; higher score indicates more symptoms of depression
Time Frame
0 Weeks, 8 Weeks, 6 Months, 12 Months
Title
Anxiety
Description
Generalized Anxiety Disorder 7-Item (GAD-7); 0-21; higher score indicates more symptoms of anxiety
Time Frame
0 Weeks, 8 Weeks, 6 Months, 12 Months
Title
Social Support
Description
Medical Outcome Study Social Support Survey (MOS); 18-90; higher scores indicate greater perceived social support
Time Frame
0 Weeks, 8 Weeks, 6 Months, 12 Months
Title
Gratitude
Description
Gratitude Questionnaire 6-Item (GQ-6); 6-42; higher scores indicate greater gratitude
Time Frame
0 Weeks, 8 Weeks, 6 Months, 12 Months
Title
Optimism
Description
Life Orientation Test-Revised (LOT-R); 0-40; higher scores indicate greater optimism
Time Frame
0 Weeks, 8 Weeks, 6 Months, 12 Months
Title
Coping Strategies
Description
Measure of Current Status Part A (MOCS-A); 0-52; higher scores indicate greater perceived ability to cope
Time Frame
0 Weeks, 8 Weeks, 6 Months, 12 Months
Title
Mindfulness
Description
Cognitive and Affective Mindfulness Scale (CAMS); 10-40; higher scores indicate greater mindfulness
Time Frame
0 Weeks, 8 Weeks, 6 Months, 12 Months
Title
Empathy
Description
Interpersonal Reactivity Index (IRI) Empathy Subscale; 7-Items; 0-28; higher scores indicate greater empathy
Time Frame
0 Weeks, 8 Weeks, 6 Months, 12 Months
Title
Pain Intensity
Description
Graded Chronic Pain Scale (GCPS); 0-100; higher scores indicate greater pain intensity
Time Frame
0 Weeks, 8 Weeks, 6 Months, 12 Months
Title
Pain Interference
Description
PROMIS Pain Interference; 8-40; higher scores indicate more pain interference
Time Frame
0 Weeks, 8 Weeks, 6 Months, 12 Months
Title
Stress
Description
Perceived Stress Scale 10-Item (PSS-10); 0-21; higher scores indicate greater levels of perceived stress
Time Frame
0 Weeks, 8 Weeks, 6 Months, 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana-Maria Vranceanu, PhD
Phone
6176437996
Email
avranceanu@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher J Funes, MS
Phone
6176431168
Email
cjfunes@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana-Maria Vranceanu, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana-Maria Vranceanu, PhD
Phone
617-643-7996
Email
avranceanu@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Christopher J Funes, MS
Phone
6176431168
Email
cjfunes@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35925531
Citation
Fishbein NS, Vranceanu AM, Mace RA. Baseline characteristics of adults with neurofibromatosis enrolled on a psychosocial randomized controlled trial. J Neurooncol. 2022 Sep;159(3):637-646. doi: 10.1007/s11060-022-04104-6. Epub 2022 Aug 4.
Results Reference
derived
PubMed Identifier
35064449
Citation
Bannon SM, Hopkins SW, Grunberg VA, Vranceanu AM. Psychosocial profiles of risk and resiliency in neurofibromatoses: a person-centered analysis of illness adaptation. J Neurooncol. 2022 Feb;156(3):519-527. doi: 10.1007/s11060-021-03928-y. Epub 2022 Jan 22.
Results Reference
derived
PubMed Identifier
34570301
Citation
Mace RA, Doorley J, Bakhshaie J, Cohen JE, Vranceanu AM. Psychological resiliency explains the relationship between emotional distress and quality of life in neurofibromatosis. J Neurooncol. 2021 Nov;155(2):125-132. doi: 10.1007/s11060-021-03852-1. Epub 2021 Sep 27.
Results Reference
derived
PubMed Identifier
34409538
Citation
Doorley JD, Greenberg J, Bakhshaie J, Fishbein NS, Vranceanu AM. Depression explains the association between pain intensity and pain interference among adults with neurofibromatosis. J Neurooncol. 2021 Sep;154(2):257-263. doi: 10.1007/s11060-021-03826-3. Epub 2021 Aug 19.
Results Reference
derived
PubMed Identifier
32421171
Citation
Lester EG, Gates MV, Vranceanu AM. Mind-Body Therapy via Videoconferencing in Patients With Neurofibromatosis: Analyses of 1-Year Follow-up. Ann Behav Med. 2021 Feb 12;55(1):77-81. doi: 10.1093/abm/kaaa030.
Results Reference
derived
PubMed Identifier
30355560
Citation
Vranceanu AM, Zale EL, Funes CJ, Macklin EA, McCurley J, Park ER, Jordan JT, Lin A, Plotkin SR. Mind-Body Treatment for International English-Speaking Adults With Neurofibromatosis via Live Videoconferencing: Protocol for a Single-Blind Randomized Controlled Trial. JMIR Res Protoc. 2018 Oct 23;7(10):e11008. doi: 10.2196/11008.
Results Reference
derived

Learn more about this trial

Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing

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