A Podcast Mind-Body Program for Military Caregiver | NCT03732183

Studies
A Podcast Mind-Body Program for Military Caregiver

NCT03732183

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Mar 6, 2019Actual

Enrollment

55Actual

Phase

Not Applicable

Conditions

Stress, Psychological

Interventions

Podcast SMART-3RP

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 25, 2018Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Jun 26, 2018

First Submission Date that Met QC Criteria

Nov 2, 2018

First Posted Date

Nov 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2019

Last Update Posted Date

Mar 6, 2019Actual

Name	Class
Elizabeth Dole Foundation	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Podcast SMART-3RP	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Podcast SMART-3RP	Behavioral	28 daily podcasts, each 15 minutes.	Podcast SMART-3RP

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Patient Health Questionnaire-8 (PHQ-8)	score ranges from 0-24	1 month
Generalized Anxeity Disorder-7 (GAD-7)	score ranges from 0-21

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric Bui, M.D., Ph.D.	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MassGH		Boston	Massachusetts	02114	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013315	Stress, Psychological

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019122	Meditation

Ancestor Terms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D026443	Spiritual Therapies

Browse Leaves

Not provided

Browse Branches

Not provided