NCT03732183

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 26, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

June 26, 2018

Last Update Submit

March 5, 2019

Conditions

Stress, Psychological

Keywords

StressMilitary CaregiverCaregiverOnlinePodcastMind-BodyWellness

Outcome Measures

Primary Outcomes (1)

  • Perceived Stress Scale (PSS-10)

    total score ranges 0-40

    1 month

Secondary Outcomes (5)

  • Patient Health Questionnaire-8 (PHQ-8)

    1 month

  • Generalized Anxeity Disorder-7 (GAD-7)

    1 month

  • Medical Symptom Checklist (MSCL)

    1 month

  • PROMIS - Satisfaction with Participation in Social Roles - Short Form (SPSR):

    1 month

  • PROMIS - Ability to Participate in Social Roles and Activities - Short Form 4A (ASPRA):

    1 month

Study Arms (1)

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

Podcast SMART-3RPBEHAVIORAL

28 daily podcasts, each 15 minutes.

Also known as: SMART-3RP, Meditation
Podcast SMART-3RP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Military Caregivers
  • years of age
  • Regular Access to smartphone or computer

You may not qualify if:

  • Non-Military Caregivers
  • Under 18 years of age
  • No regular access to smartphone or computer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MassGH

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Meditation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Eric Bui, M.D., Ph.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 26, 2018

First Posted

November 6, 2018

Study Start

June 25, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

March 6, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)