Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

Mass General Brigham

Status: Completed

Conditions: Neurofibromatosis; Neurofibromatosis I; Schwannomatosis; Neurofibromatosis 2

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02298270

2013P002605a

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups, including a placebo group

Relaxation Response Resiliency Program

Experimental group

Description:

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

Treatment:

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

Health Education

Placebo Comparator group

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.

Treatment:

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