A Podcast Mind-Body Program for Military Caregiver

March 5, 2019 updated by: Eric Bui, MD, PhD, Massachusetts General Hospital

A Brief Mind-Body Program to Support Military and Veteran Caregiver Wellness: a Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • MassGH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Podcast SMART-3RP
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.
Behavioral: Podcast SMART-3RP
28 daily podcasts, each 15 minutes.
Other Names:
  • Meditation
  • SMART-3RP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale (PSS-10)
Time Frame: 1 month
total score ranges 0-40
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-8 (PHQ-8)
Time Frame: 1 month
score ranges from 0-24
1 month
Generalized Anxeity Disorder-7 (GAD-7)
Time Frame: 1 month
score ranges from 0-21
1 month
Medical Symptom Checklist (MSCL)
Time Frame: 1 month
score ranges from 0-175
1 month
PROMIS - Satisfaction with Participation in Social Roles - Short Form (SPSR):
Time Frame: 1 month
raw scores range from 8-40
1 month
PROMIS - Ability to Participate in Social Roles and Activities - Short Form 4A (ASPRA):
Time Frame: 1 month
raw scores range from 4-20
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Elizabeth Dole Foundation

Investigators

  • Principal Investigator: Eric Bui, M.D., Ph.D., Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

June 26, 2018

First Submitted That Met QC Criteria

November 2, 2018

First Posted (Actual)

November 6, 2018

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017P002426

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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