Stress, PsychologicalNCT03732183
A Podcast Mind-Body Program for Military Caregiver
A study testing Podcast SMART-3RP in people with Stress, Psychological, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Podcast SMART-3RP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Military Caregivers
- 18 years of age
- Regular Access to smartphone or computer
Who cannot join
- Non-Military Caregivers
- Under 18 years of age
- No regular access to smartphone or computer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress, Psychological
- Being tested
- Podcast SMART-3RP
- Keywords
- Stress, Military Caregiver, Caregiver, Online, Podcast, Mind-Body, Wellness
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Podcast SMART-3RPBehavioural
Also called SMART-3RP, Meditation
28 daily podcasts, each 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Podcast SMART-3RP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS-10)
total score ranges 0-40
Measured: 1 month
Secondary outcomes (5)
Patient Health Questionnaire-8 (PHQ-8)
score ranges from 0-24
Measured: 1 month
Generalized Anxeity Disorder-7 (GAD-7)
score ranges from 0-21
Measured: 1 month
Medical Symptom Checklist (MSCL)
score ranges from 0-175
Measured: 1 month
PROMIS - Satisfaction with Participation in Social Roles - Short Form (SPSR):
raw scores range from 8-40
Measured: 1 month
PROMIS - Ability to Participate in Social Roles and Activities - Short Form 4A (ASPRA):
raw scores range from 4-20
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start25 Jun 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Elizabeth Dole Foundation
- Responsible party
- Principal investigator, Eric Bui, MD, PhD, Massachusetts General Hospital
- Investigators
- Eric Bui, M.D., Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732183
- Sponsor's protocol ID
- 2017P002426
- Status last verified
- Mar 2019
- First submitted
- 26 Jun 2018
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Mind-Body Program to Support Military and Veteran Caregiver Wellness: a Pilot Study
- ClinicalTrials.gov ID
- NCT03732183
- Acronym / sponsor ID
- 2017P002426
- Conditions
- Stress, Psychological
- Keywords
- Stress, Military Caregiver, Caregiver, Online, Podcast, Mind-Body, Wellness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Elizabeth Dole Foundation
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Podcast SMART-3RP | Experimental | Behavioral: Podcast SMART-3RPThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Military Caregivers
- 18 years of age
- Regular Access to smartphone or computer
Key exclusion criteria (3 listed)
- Non-Military Caregivers
- Under 18 years of age
- No regular access to smartphone or computer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Podcast SMART-3RPAlso: SMART-3RP, Meditation28 daily podcasts, each 15 minutes. | Behavioural | Podcast SMART-3RP |
Primary outcome
Perceived Stress Scale (PSS-10)
Time frame: 1 month
total score ranges 0-40
5 secondary outcomes
Patient Health Questionnaire-8 (PHQ-8)
Time frame: 1 month
Generalized Anxeity Disorder-7 (GAD-7)
Time frame: 1 month
Medical Symptom Checklist (MSCL)
Time frame: 1 month
PROMIS - Satisfaction with Participation in Social Roles - Short Form (SPSR):
Time frame: 1 month
PROMIS - Ability to Participate in Social Roles and Activities - Short Form 4A (ASPRA):
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Stress, Psychological
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Not yet recruiting
Financial Tools Access and Navigation (FinTAN)
Serious Mental Illness, Financial Hardship
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Bui, M.D., Ph.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Podcast SMART-3RP in people with Stress, Psychological, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (PSS-10) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.