Back to resultsA Podcast Mind-Body Program for Military Caregiver
Primary Purpose
Stress, Psychological
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Podcast SMART-3RP
Sponsored by
About this trial
This is an interventional supportive care trial for Stress, Psychological focused on measuring Stress, Military Caregiver, Caregiver, Online, Podcast, Mind-Body, Wellness
Eligibility Criteria
Inclusion Criteria:
- Military Caregivers
- 18 years of age
- Regular Access to smartphone or computer
Exclusion Criteria:
- Non-Military Caregivers
- Under 18 years of age
- No regular access to smartphone or computer
Sites / Locations
- MassGH
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Podcast SMART-3RP
Arm Description
The mind body intervention is delivered by podcast and material posted online. All session content will be audio recorded into 15-min audio-recordings that will be delivered on a podcast platform. During the course of the 4-week program, one new "podcast session" will be delivered every day.
Outcomes
Primary Outcome Measures
Perceived Stress Scale (PSS-10)
total score ranges 0-40
Secondary Outcome Measures
Patient Health Questionnaire-8 (PHQ-8)
score ranges from 0-24
Generalized Anxeity Disorder-7 (GAD-7)
score ranges from 0-21
Medical Symptom Checklist (MSCL)
score ranges from 0-175
PROMIS - Satisfaction with Participation in Social Roles - Short Form (SPSR):
raw scores range from 8-40
PROMIS - Ability to Participate in Social Roles and Activities - Short Form 4A (ASPRA):
raw scores range from 4-20
Full Information
NCT ID
NCT03732183
First Posted
June 26, 2018
Last Updated
March 5, 2019
Sponsor
Massachusetts General Hospital
Collaborators
Elizabeth Dole Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03732183
Brief Title
A Podcast Mind-Body Program for Military Caregiver
Official Title
A Brief Mind-Body Program to Support Military and Veteran Caregiver Wellness: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 25, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Elizabeth Dole Foundation
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 purpose of this pilot study is to test the efficacy, feasibility, and acceptability of a brief, online, mind-body wellness program to reduce stress and promote resilience in military caregivers.
Detailed Description
The investigators are piloting a brief, online, mind-body program to reduce stress in military caregivers. Eligible participants are, 1) At least 18 years old 2) Serving as military caregivers and 3) have regular access to a smartphone or computer. The investigators have adapted the SMART-3RP into a brief podcast, which we plan to administer daily. Participants will be administered questionnaires at baseline, mid-program, and post-program to assess for symptoms of stress, anxiety, and depression. Participants will be compensated for completing all measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
Stress, Military Caregiver, Caregiver, Online, Podcast, Mind-Body, Wellness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Podcast SMART-3RP
Arm Type
Experimental
Arm Description
The mind body intervention is delivered by podcast and material posted online. All session content will be audio recorded into 15-min audio-recordings that will be delivered on a podcast platform. During the course of the 4-week program, one new "podcast session" will be delivered every day.
Intervention Type
Behavioral
Intervention Name(s)
Podcast SMART-3RP
Other Intervention Name(s)
SMART-3RP, Meditation
Intervention Description
28 daily podcasts, each 15 minutes.
Primary Outcome Measure Information:
Title
Perceived Stress Scale (PSS-10)
Description
total score ranges 0-40
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire-8 (PHQ-8)
Description
score ranges from 0-24
Time Frame
1 month
Title
Generalized Anxeity Disorder-7 (GAD-7)
Description
score ranges from 0-21
Time Frame
1 month
Title
Medical Symptom Checklist (MSCL)
Description
score ranges from 0-175
Time Frame
1 month
Title
PROMIS - Satisfaction with Participation in Social Roles - Short Form (SPSR):
Description
raw scores range from 8-40
Time Frame
1 month
Title
PROMIS - Ability to Participate in Social Roles and Activities - Short Form 4A (ASPRA):
Description
raw scores range from 4-20
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Military Caregivers
18 years of age
Regular Access to smartphone or computer
Exclusion Criteria:
Non-Military Caregivers
Under 18 years of age
No regular access to smartphone or computer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Bui, M.D., Ph.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MassGH
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Podcast Mind-Body Program for Military Caregiver
We'll reach out to this number within 24 hrs