- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06582927
Mindfulness Training for First Responders
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Coral Gables, Florida, United States, 33146
- University of Miami
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals who are between 18 and 75 years of age
- Individuals who are fluent English speakers
- Individuals who are able to adequately and independently use electronic devices, such as a laptop, computer, or tablet, and have Internet connection
- Individuals who are willing and able to consent to participate in the study
- Participants in all phases of the study must be individuals who are affiliated with the Los Angeles County Fire Department peer support group.
Exclusion Criteria:
1. Individuals with an active and untreated mental health issue and/or hospitalization for psychological/mental health issues within the past month
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mindfulness Training Group A
Participants in this group will receive mindfulness training in up to 8 weeks.
|
MBAT is an evidence-based 8-hour mindfulness program that comprises 4 central topics and associated practices. The concentration topic introduces participants to mindfulness "basics," including discussion of focused attention and mind wandering. The body awareness theme involves the cultivation of greater self-awareness, and the development of equanimity. The open monitoring theme emphasizes awareness of and receptivity to changing experiences and moments of uncertainty. The theme of connection addresses leadership and group cohesion, and the cultivation of kindness and connection with others. The course content and materials in the present study will entail the foundational MBAT curriculum and other related content delivered virtually over Zoom but will consist of 8, 1-hour sessions delivered across 8 consecutive weeks. |
|
Active Comparator: Wait-list condition Group B
Participants in this group will be on a waiting list to receive the identical intervention as the experimental group at a later time.
Total participation in the mindfulness training will be 8 weeks
|
MBAT is an evidence-based 8-hour mindfulness program that comprises 4 central topics and associated practices. The concentration topic introduces participants to mindfulness "basics," including discussion of focused attention and mind wandering. The body awareness theme involves the cultivation of greater self-awareness, and the development of equanimity. The open monitoring theme emphasizes awareness of and receptivity to changing experiences and moments of uncertainty. The theme of connection addresses leadership and group cohesion, and the cultivation of kindness and connection with others. The course content and materials in the present study will entail the foundational MBAT curriculum and other related content delivered virtually over Zoom but will consist of 8, 1-hour sessions delivered across 8 consecutive weeks. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in resilience
Time Frame: Baseline to week 11
|
Resilience is assessed via the 6-item Brief Resilience Scale (BRS).
The scores range from 6 to 30, with a higher score indicating a higher level of resilience.
|
Baseline to week 11
|
|
Change in sustained attention
Time Frame: Baseline to week 11
|
The Sustained Attention to Response Task (SART) is used to assess attentional performance and mind wandering (i.e., off-task thinking which is typically self-generated and compromises the performance of the task at hand).
The task uses a continuous performance paradigm involving button presses to frequently presented nontargets (numbers 0, 1, 2, 4, 5, 6, 7, 8, and 9) but requires the participants to withhold their motor response to the infrequent target (number 3).
Withholding responses only to infrequent targets encourages a pre-potent response and mind wandering.
Real-time subjective experience of mind wandering during SART is assessed through experience-sampling probes randomly presented throughout the task.
|
Baseline to week 11
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in positive affect
Time Frame: Baseline to week 11
|
Positive Affect is assessed with the 5-item positive sub-scale from Positive and Negative Affect Schedule (PANAS).
PANAS Positive has a range of scores from 5 to 25, with a higher score indicating a higher positive mood.
|
Baseline to week 11
|
|
Change in negative affect
Time Frame: Baseline to week 11
|
Negative Affect is assessed with the 5-item negative sub-scale from Positive and Negative Affect Schedule (PANAS-10).
PANAS Negative has a range of scores from 5 to 25, with a higher score indicating a higher negative mood.
|
Baseline to week 11
|
|
Change in perceived stress
Time Frame: Baseline to week 11
|
Perceived stress is assessed with the 4-item Perceived Stress Scale (PSS-4).
PSS-4 has a range of scores from 0 to 16, with a higher score indicating a higher level of perceived stress.
|
Baseline to week 11
|
|
Change in burnout
Time Frame: Baseline to week 11
|
Burnout is assessed with the 12-item Burnout Assessment Tool (BAT-12).
BAT-12 has a range of score from 1 to 5, with a higher score indicated a higher level of burnout.
|
Baseline to week 11
|
|
Change in decentering
Time Frame: Baseline to week 11
|
Decentering is assessed via the 11-item decentering sub-scale of the experience questionnaire (EQ-D).
The decentering score ranges from 1 to 55, with a higher score indicating a higher level of decentering.
|
Baseline to week 11
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Amishi Jha, PhD, University of Miami
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20240877
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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