Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

NCT02298270 | Completed

• 1 other identifier: 2013P002605a
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurofibromatosis; Neurofibromatosis I; Neurofibromatosis 2; Schwannomatosis

Keywords

Neurofibromatosis; NF I; NF 2; Schwannomatosis; Stress Management; Resiliency; Skype

Outcome Measures

Primary Outcomes (2)

• 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.

  Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)

• 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.

  Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)

Secondary Outcomes (17)

• Perceived Stress Scale (PSS-10)

  Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)

• The Pain Catastrophizing Scale (PCS)

  Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)

• Pain Numerical Rating Scale (Pain NRS)

  Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)

• Patient Health Quesionnaire (PHQ)

  Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)

• Brief Pain Inventory (BPI)

  Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)

Study Arms (2)

Relaxation Response Resiliency Program

EXPERIMENTAL

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

Behavioral: The Relaxation Response Resiliency Program (3RP) via Skype

Health Education

PLACEBO COMPARATOR

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.

Behavioral: The Relaxation Response Resiliency Program (3RP) via Skype

Interventions

The Relaxation Response Resiliency Program (3RP) via Skype BEHAVIORAL

8-week group intervention, delivered via Skype, teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga.

Health Education; Relaxation Response Resiliency Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• The Children's Tumor Foundation: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02140, United States

Location

MeSH Terms

Conditions

Neurofibromatoses; Neurofibromatosis 1; Neurofibromatosis 2; Schwannomatosis

Condition Hierarchy (Ancestors)

Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neuroma, Acoustic; Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neuroma; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Neoplasms; Cranial Nerve Diseases

Study Officials

• Ana-Maria Vranceanu, PhD

  MGH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 21, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: June 23, 2016

Record last verified: 2016-06

Locations

US (1)