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Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

Primary Purpose

Neurofibromatosis, Neurofibromatosis I, Neurofibromatosis 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Relaxation Response Resiliency Program (3RP) via Skype
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neurofibromatosis focused on measuring Neurofibromatosis, NF I, NF 2, Schwannomatosis, Stress Management, Resiliency, Skype

Eligibility Criteria

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

Inclusion Criteria:

  1. Age 18 or older
  2. Can read and speak English at or above the 6th grade level
  3. Diagnosis of neurofibromatosis type 1, neurofibromatosis type 2, or schwannomatosis

Exclusion Criteria:

  1. Severe active or untreated major mental illness that would interfere with study participation, to be determined at the discretion of the study investigator (e.g. untreated psychosis or suicidality)
  2. Recent (within past 3 months) change in antidepressant medication
  3. Use of formal relaxation training (including past participation in a mind-body program), currently or in the past 6 months.
  4. Unable or unwilling to sign the informed consent documents
  5. Unable or unwilling to complete psychological assessments online via the REDCap system.
  6. Unable or unwilling to participate in an intervention delivered via videoconferencing with Skype.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Relaxation Response Resiliency Program

Health Education

Arm Description

Participants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills.

Participants will receive and 8-week general stress and health education program, with none of the active relaxation and resiliency-based components being tested in the experimental condition.

Outcomes

Primary Outcome Measures

Satisfaction with Life (SWL)
The Satisfaction with Life (SWL) scale is a reliable and valid 5-item self-report measure of global life satisfaction. Responses are made on a 7-point scale with higher scores reflecting higher life satisfaction.
Quality of Life (WHOQOL-BREF)
The WHOQOL-BREF comprises of 26 items which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.

Secondary Outcome Measures

Perceived Stress Scale (PSS-10)
The PSS is a widely used psychological instrument for the measurement of the perception of stress. This 10-itam scale is designed to measure the degree to which situations in one's life are appraised, or considered stressful. The scores range from 0-40, with a higher score indicating higher perceived stress. Items were designed to detect how unpredictable, uncontrollable and overloaded respondents find their lives.
The Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) is widely used to assess cognitive and affective responses to pain and to evaluate pain management program outcomes.
Pain Numerical Rating Scale (Pain NRS)
The Pain NRS is a scale for patient self-reporting measurements of pain. The measure was depicted by REINS as a standard measure to use in Neurofibromatosis clinical trials.
Patient Health Quesionnaire (PHQ)
The PHQ measures symptoms of depression and functional impairment.
Brief Pain Inventory (BPI)
The Brief Pain Inventory (BPI) allows patients to rate the severity of their pain (BPI-S) and the degree to which their pain interferes with common dimensions of feeling and function (BPI-I).
Cognitive and Affective Mindfulness Scale (CAMS)
The CAMS measures the degree to which individuals experience their thoughts and feelings.
Posttraumatic Growth Inventory (PGI)
The PGI is an instrument for assessing positive outcomes reported by persons who have experienced traumatic events.
Interpersonal Reactivity Index (IRI)
The IRI assesses the cognitive and affective dimensions of empathy.
Distress Analogue Scales
The Distress Analogue Scales measure participants' levels of stress, coping, distress, and discomfort.
Epworth Sleepiness Scale (ESS)
The Epworth Sleepiness Scale (ESS) has been widely used to assess a person's average level of daytime sleepiness in daily life.
Measure of Current Status (MOCS-A)
The MOCS-A is a 13-item measure assessing participants' current self-perceived status on several skills such as: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. Responses are made on a 7-point scale with higher scores reflecting higher life satisfaction.
Life Orientation Test (LOT) Optimism Scale
The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism.
The Gratitude Questionnaire (GQ-6)
The GQ-6 revised is a 6-item measure that assesses individual differences in the proneness to experience gratitude in daily life. Scores range from 6-42, with a higher score indicating a greater sense of gratitude.
Functional Assessment of Chronic Illness Therapy- Fatigue Scale (FACIT-Fatigue)
The FACIT-Fatigue measures participants' tiredness, weakness, and difficulty conducting usual activities due to fatigue.
Functional Assessment of Chronic Illness Therapy- Spirituality Scale (FACIT-Sp)
The FACIT-Sp measures participants' spiritual well-being (sense of meaning in life and the sense of strength in one's faith) over the past 7 days.
Medical Outcomes Study (MOS) Social Support Survey
The MOS Social Support Survey measures various dimensions of social support.
The 14-Item Resiliency Scale (RS-14)
The RS-14 measures stress coping ability in the face of adversity.

Full Information

First Posted
November 17, 2014
Last Updated
June 21, 2016
Sponsor
Massachusetts General Hospital
Collaborators
The Children's Tumor Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02298270
Brief Title
Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype
Official Title
Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
The Children's Tumor Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study tests the efficacy of an 8-week, Skype-based, group resiliency training intervention (The Relaxation Response Resiliency Program) for improving psychological stress in patients with Neurofibromatosis. A control group will receive a general health education curriculum. The investigators hypothesize that patients will improve on measures of psychological stress as a result of the resiliency program. A substudy (Unique Protocol ID: 2013P002605b) has been approved to test this study on a sub-population: patients with NF2 who are hard of hearing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurofibromatosis, Neurofibromatosis I, Neurofibromatosis 2, Schwannomatosis
Keywords
Neurofibromatosis, NF I, NF 2, Schwannomatosis, Stress Management, Resiliency, Skype

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Relaxation Response Resiliency Program
Arm Type
Experimental
Arm Description
Participants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills.
Arm Title
Health Education
Arm Type
Placebo Comparator
Arm Description
Participants will receive and 8-week general stress and health education program, with none of the active relaxation and resiliency-based components being tested in the experimental condition.
Intervention Type
Behavioral
Intervention Name(s)
The Relaxation Response Resiliency Program (3RP) via Skype
Intervention Description
8-week group intervention, delivered via Skype, teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga.
Primary Outcome Measure Information:
Title
Satisfaction with Life (SWL)
Description
The Satisfaction with Life (SWL) scale is a reliable and valid 5-item self-report measure of global life satisfaction. Responses are made on a 7-point scale with higher scores reflecting higher life satisfaction.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Quality of Life (WHOQOL-BREF)
Description
The WHOQOL-BREF comprises of 26 items which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Secondary Outcome Measure Information:
Title
Perceived Stress Scale (PSS-10)
Description
The PSS is a widely used psychological instrument for the measurement of the perception of stress. This 10-itam scale is designed to measure the degree to which situations in one's life are appraised, or considered stressful. The scores range from 0-40, with a higher score indicating higher perceived stress. Items were designed to detect how unpredictable, uncontrollable and overloaded respondents find their lives.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
The Pain Catastrophizing Scale (PCS)
Description
The Pain Catastrophizing Scale (PCS) is widely used to assess cognitive and affective responses to pain and to evaluate pain management program outcomes.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Pain Numerical Rating Scale (Pain NRS)
Description
The Pain NRS is a scale for patient self-reporting measurements of pain. The measure was depicted by REINS as a standard measure to use in Neurofibromatosis clinical trials.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Patient Health Quesionnaire (PHQ)
Description
The PHQ measures symptoms of depression and functional impairment.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Brief Pain Inventory (BPI)
Description
The Brief Pain Inventory (BPI) allows patients to rate the severity of their pain (BPI-S) and the degree to which their pain interferes with common dimensions of feeling and function (BPI-I).
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Cognitive and Affective Mindfulness Scale (CAMS)
Description
The CAMS measures the degree to which individuals experience their thoughts and feelings.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Posttraumatic Growth Inventory (PGI)
Description
The PGI is an instrument for assessing positive outcomes reported by persons who have experienced traumatic events.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Interpersonal Reactivity Index (IRI)
Description
The IRI assesses the cognitive and affective dimensions of empathy.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Distress Analogue Scales
Description
The Distress Analogue Scales measure participants' levels of stress, coping, distress, and discomfort.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32). Also administered at mid-interevention, before each group session.
Title
Epworth Sleepiness Scale (ESS)
Description
The Epworth Sleepiness Scale (ESS) has been widely used to assess a person's average level of daytime sleepiness in daily life.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Measure of Current Status (MOCS-A)
Description
The MOCS-A is a 13-item measure assessing participants' current self-perceived status on several skills such as: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. Responses are made on a 7-point scale with higher scores reflecting higher life satisfaction.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Life Orientation Test (LOT) Optimism Scale
Description
The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
The Gratitude Questionnaire (GQ-6)
Description
The GQ-6 revised is a 6-item measure that assesses individual differences in the proneness to experience gratitude in daily life. Scores range from 6-42, with a higher score indicating a greater sense of gratitude.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Functional Assessment of Chronic Illness Therapy- Fatigue Scale (FACIT-Fatigue)
Description
The FACIT-Fatigue measures participants' tiredness, weakness, and difficulty conducting usual activities due to fatigue.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Functional Assessment of Chronic Illness Therapy- Spirituality Scale (FACIT-Sp)
Description
The FACIT-Sp measures participants' spiritual well-being (sense of meaning in life and the sense of strength in one's faith) over the past 7 days.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Medical Outcomes Study (MOS) Social Support Survey
Description
The MOS Social Support Survey measures various dimensions of social support.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
The 14-Item Resiliency Scale (RS-14)
Description
The RS-14 measures stress coping ability in the face of adversity.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or older Can read and speak English at or above the 6th grade level Diagnosis of neurofibromatosis type 1, neurofibromatosis type 2, or schwannomatosis Exclusion Criteria: Severe active or untreated major mental illness that would interfere with study participation, to be determined at the discretion of the study investigator (e.g. untreated psychosis or suicidality) Recent (within past 3 months) change in antidepressant medication Use of formal relaxation training (including past participation in a mind-body program), currently or in the past 6 months. Unable or unwilling to sign the informed consent documents Unable or unwilling to complete psychological assessments online via the REDCap system. Unable or unwilling to participate in an intervention delivered via videoconferencing with Skype.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana-Maria Vranceanu, PhD
Organizational Affiliation
MGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02140
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

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