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A Podcast Mind-Body Program for Military Caregiver

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03732183
Recruitment Status : Completed
First Posted : November 6, 2018
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
Elizabeth Dole Foundation
Information provided by (Responsible Party):
Eric Bui, MD, PhD, Massachusetts General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stress, Psychological Behavioral: Podcast SMART-3RP Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Brief Mind-Body Program to Support Military and Veteran Caregiver Wellness: a Pilot Study
Actual Study Start Date : June 25, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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:
  • SMART-3RP
  • Meditation


Outcome Measures
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Primary Outcome Measures :
  1. Perceived Stress Scale (PSS-10) [ Time Frame: 1 month ]
    total score ranges 0-40


Secondary Outcome Measures :
  1. Patient Health Questionnaire-8 (PHQ-8) [ Time Frame: 1 month ]
    score ranges from 0-24

  2. Generalized Anxeity Disorder-7 (GAD-7) [ Time Frame: 1 month ]
    score ranges from 0-21

  3. Medical Symptom Checklist (MSCL) [ Time Frame: 1 month ]
    score ranges from 0-175

  4. PROMIS - Satisfaction with Participation in Social Roles - Short Form (SPSR): [ Time Frame: 1 month ]
    raw scores range from 8-40

  5. PROMIS - Ability to Participate in Social Roles and Activities - Short Form 4A (ASPRA): [ Time Frame: 1 month ]
    raw scores range from 4-20


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03732183


Locations
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United States, Massachusetts
MassGH
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Elizabeth Dole Foundation
Investigators
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Principal Investigator: Eric Bui, M.D., Ph.D. Massachusetts General Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Eric Bui, MD, PhD, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03732183    
Other Study ID Numbers: 2017P002426
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eric Bui, MD, PhD, Massachusetts General Hospital:
Stress
Military Caregiver
Caregiver
Online
 Podcast
Mind-Body
Wellness
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms