A Podcast Mind-Body Program for Military Caregiver

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03732183
• Other study ID #: 2017P002426
• Status: Completed
• Phase: N/A
• Start date: June 25, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

Behavioral:
• Podcast SMART-3RP
28 daily podcasts, each 15 minutes.

Locations

Country	Name	City	State
United States	MassGH	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Elizabeth Dole Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived Stress Scale (PSS-10)	total score ranges 0-40	1 month
Secondary	Patient Health Questionnaire-8 (PHQ-8)	score ranges from 0-24	1 month
Secondary	Generalized Anxeity Disorder-7 (GAD-7)	score ranges from 0-21	1 month
Secondary	Medical Symptom Checklist (MSCL)	score ranges from 0-175	1 month
Secondary	PROMIS - Satisfaction with Participation in Social Roles - Short Form (SPSR):	raw scores range from 8-40	1 month
Secondary	PROMIS - Ability to Participate in Social Roles and Activities - Short Form 4A (ASPRA):	raw scores range from 4-20	1 month