Occupational-based Secondary TraumaNCT04122534
Somatic Mindfulness Training for a Healthy Workforce: Student Pilot Sample
A study testing Somatic Mindfulness Training in people with Occupational-based Secondary Trauma, run by Montana State University at 1 site in United States.
Trial summary
This pilot study evaluates a somatic mindfulness training. Reductions in mental and physical health correlates of secondary trauma are assessed using a pretest-posttest design. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Occupational-based Secondary Trauma
- What is being tested?
- Somatic Mindfulness Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2019to 15 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must be either employed or volunteering as a victim service provider, or enrolled at Montana State University as an undergraduate student.
Who cannot join
- Participant is under age 18.
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study evaluates a somatic mindfulness training. Reductions in mental and physical health correlates of secondary trauma are assessed using a pretest-posttest design.
- Conditions
- Occupational-based Secondary Trauma
- Being tested
- Somatic Mindfulness Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatic Mindfulness TrainingBehavioural
Educational and experiential training to reduce occupational-based secondary trauma.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Treatment groups receives the intervention training. Receives: Behavioral: Somatic Mindfulness Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary Traumatic Stress Scale
Measures occupational-based secondary traumatic stress using a total scale range of 17(min) to 85 (max). Scores above 37 indicate moderate or higher secondary traumatic stress.
Measured: This outcome measure will be assessed at week 15.
Secondary outcomes (1)
Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Measures symptoms of post-traumatic stress disorder using a total scale range of 0 (min) to 80 (max), with a score of 33 or higher indicating that participants maybe suffering from Post Traumatic Stress Disorder.
Measured: This outcome measure will be assessed at week 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start5 Sep 2019
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Occupational-based Secondary TraumaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Knight, Montana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122534
- Sponsor's protocol ID
- 1111
- Status last verified
- Dec 2020
- First submitted
- 28 Sep 2019
- Last updated
- 31 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatic Mindfulness Training for a Healthy Workforce: Student Pilot Sample
- ClinicalTrials.gov ID
- NCT04122534
- Acronym / sponsor ID
- 1111
- Conditions
- Occupational-based Secondary Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Posted 31 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study evaluates a somatic mindfulness training. Reductions in mental and physical health correlates of secondary trauma are assessed using a pretest-posttest design.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Somatic Mindfulness TrainingTreatment groups receives the intervention training. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participant must be either employed or volunteering as a victim service provider, or enrolled at Montana State University as an undergraduate student.
Key exclusion criteria (1 listed)
- Participant is under age 18.
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 |
|---|---|---|
| Somatic Mindfulness TrainingEducational and experiential training to reduce occupational-based secondary trauma. | Behavioural | Treatment Group |
Primary outcome
Secondary Traumatic Stress Scale
Time frame: This outcome measure will be assessed at week 15.
Measures occupational-based secondary traumatic stress using a total scale range of 17(min) to 85 (max). Scores above 37 indicate moderate or higher secondary traumatic stress.
1 secondary outcome
Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: This outcome measure will be assessed at week 15.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somatic Mindfulness Training in people with Occupational-based Secondary Trauma, run by Montana State University 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 1 inclusion and 1 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 31 Dec 2020. 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?
Yes. Results are posted in the registry (first posted 31 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Secondary Traumatic Stress Scale (time frame: This outcome measure will be assessed at week 15.). 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 31 Dec 2020.