Post Traumatic Stress DisorderHAZMATNCT04909216
Mindful Attention Training Workshop for Firefighters
A study testing Mindful Attention Workshop in people with Post Traumatic Stress Disorder and Mindfulness, run by University of Houston at 1 site in United States.
Trial summary
The overarching goal of this study is to demonstrate the efficacy, feasibility, and acceptability of Mindful Attention Training (MAT), a novel mindfulness-based intervention that is specifically developed for firefighters. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder, Mindfulness, Firefighters
- What is being tested?
- Mindful Attention Workshop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2021to 14 Apr 2023
- 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
- ≥ 18 years of age
- Current employment as a firefighter with the Houston Fire Department
Who cannot join
- Persons who are not actively employed in the Houston Fire Department (e.g. former firefighters, retired firefighters)
- Current imminent risk of suicidality and/or homicidality (i.e., past month ideation with intent or plan)
- Inability to provide verbal or written consent
- Study personnel will not recruit or screen for individuals who fall into the following categories: pregnant women, prisoners, students for whom study personnel have direct access to/influence on grades, or economically and/or educationally disadvantaged persons
Trial locations and contacts
1 site in 1 country.
United States1 site
Trauma and Stress Studies Center
Houston, Texas, 77204
About this study
Official title: Healthy Action Zone - Mindful Attention Training: A Mindfulness-Based Workshop for Firefighters
The overarching goal of this study is to demonstrate the efficacy, feasibility, and acceptability of Mindful Attention Training (MAT), a novel mindfulness-based intervention that is specifically developed for firefighters. This project is designed to improve the health of firefighters, an integral, essential component of our national and international communities. Moreover, the study aims to promote health service psychologists by enhancing our contributions to the mental healthcare of firefighters, an understudied and underserved segment of the population by virtue of their service to our communities. This study therefore has significant potential to identify, develop, and promote an effective model of quality, evidence-based mental health promotion and illness prevention by integrating health service psychology into the fire service.
Read the detailed description
Firefighters are repeatedly exposed to traumatic and stressful situations, increasing their vulnerability for the development of various psychological symptoms and disorders. As many as 32.4% of firefighters meet criteria for posttraumatic stress disorder (PTSD) with significantly more experiencing significant subclinical PTSD symptoms. Approximately 22% of firefighters are also at risk for depression, 46.8% reported serious suicidal ideation, and 15.5% reported having made a suicide attempt during heir firefighter tenure6. Alcohol use disorder (AUD) among firefighters is estimated at approximately 50%, nearly twice that of the general population.
Given the chronically stressful and potentially traumatic nature of the firefighting profession and the high rates of psychological disturbances among firefighters, the development of specialized mental health promotion and illness prevention programs for this vulnerable population is a priority. Mindfulness, generally defined as bringing one's full attention to the present moment and taking a stance of nonjudgmental acceptance to the ongoing flow of sensations, thoughts, and/or emotional states, has significant clinical relevance to the prevention and treatment of various psychological conditions. Mindfulness-based interventions have demonstrated efficacy with regard to various psychological symptoms, including PTSD, depression, and alcohol use. In a military context, mindful attention training has shown promise in terms of reducing the impact of combat on psychological health. However, no specialized mindfulness-based interventions exist for firefighters.
The overarching goal of this study is to demonstrate the efficacy, feasibility, and acceptability of Mindful Attention Training (MAT), a novel mindfulness-based intervention that is specifically developed for firefighters. This project is designed to improve the health of firefighters, an integral, essential component of our national and international communities. Moreover, the study aims to promote health service psychologists by enhancing our contributions to the mental healthcare of firefighters, an understudied and underserved segment of the population by virtue of their service to our communities. This study therefore has significant potential to identify, develop, and promote an effective model of quality, evidence-based mental health promotion and illness prevention by integrating health service psychology into the fire service.
Aim 1: To evaluate the efficacy of the Mindful Attention Training (MAT) workshop, as compared to waitlist comparison ("as usual" condition), on mental health promotion among firefighters, as defined by: self-reported levels of (1a) mindful attention and awareness, (1b) nonjudgmental acceptance, and (1c) nonreactivity at each time point.
Aim 2: To evaluate the efficacy of the MAT workshop, as compared to waitlist, on psychological 'illness' prevention among firefighters, as defined by: self-reported symptom severity of PTSD, depression, anxiety, suicidal ideation, and alcohol use at each time point.
Aim 3: To evaluate the feasibility and acceptability of the MAT workshop, as compared to waitlist, as defined by: (1) firefighters' self-reported helpfulness of the workshop and (2) firefighters' self-reported satisfaction ratings of the workshop.
- Being tested
- Mindful Attention Workshop
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Attention WorkshopOther
The 90-minute workshop will include a 15-minute break and include up to 15 participants. The workshop will be led by peer support staff, fire department psychologists, and/or fire department doctoral psychology practicum students. Each workshop will be facilitate by up to 3 workshop leaders. The workshop will provide (1) psychoeducation regarding common mental health concerns among firefighters, (2) introduction to the concept of mindful attention, why it is relevant to firefighters, and how it can prevent or decrease mental health symptoms, (3) 5 experiential mindful attention training exercises, and (4) discussion. Workshop co-leaders will teach 5 mindful attention exercises, and firefighters will practice each exercise and then engage in discussion about their experiences and provide feedback regarding the utility of the exercise for them personally and for firefighters, generally.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Attention Workshop | Experimental | 50 participants will be randomized to the Mindful Attention Training (MAT) workshop. The 90-minute workshop will be conducted in group, online format. Receives: Other: Mindful Attention Workshop |
| Waitlist Control | No intervention | 50 participants will be randomized to the waitlist control condition ("as usual" condition). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in mindfulness
To evaluate the efficacy of the Mindful Attention Training (MAT) workshop by examining self-reported levels of (1) nonjudgmental acceptance, (2) nonreactivity as well as (3) psychological resilience and (4) self-compassion at each time point using the following measure:
- Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2006): 39-item measure that assesses a participant's capacity for the following five factors: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
Measured: Administered at each of the following timepoints: baseline, 1-week follow-up, 2-week follow-up, 1-month follow-up, 3-month follow-up, and 6-month follow-up
Changes in mindful attention
To evaluate the efficacy of the Mindful Attention Training (MAT) workshop by examining self-reported levels of mindful attention and awareness at each time point using the following measure:
- Mindful Attention Awareness Scale (MAAS; Brown \& Ryan, 2003): 15-item scale assessing a participant's capacity for mindful attention, a key component of mindfulness.
Measured: Administered at each of the following timepoints: baseline, 1-week follow-up, 2-week follow-up, 1-month follow-up, 3-month follow-up, and 6-month follow-up
Changes in PTSD symptom severity
To evaluate the efficacy of the Mindful Attention Training (MAT) workshop on the symptom severity of PTSD at each time point using the following measure:
- Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders (PCL-5): 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of PTSD over the past month.
Measured: Administered at each of the following timepoints: baseline, 1-week follow-up, 2-week follow-up, 1-month follow-up, 3-month follow-up, and 6-month follow-up
Changes in hazardous drinking patterns
To evaluate the efficacy of the Mindful Attention Training (MAT) workshop on the alcohol use and alcohol use severity at each time point using the following measure:
- Alcohol Use Disorders Identification Test (AUDIT): 10-item screening measurement to assess any hazardous and harmful alcohol consumption during the past year.
Measured: Administered at each of the following timepoints: baseline, 1-week follow-up, 2-week follow-up, 1-month follow-up, 3-month follow-up, and 6-month follow-up
Changes in depressive symptoms
To evaluate the efficacy of the Mindful Attention Training (MAT) workshop on the symptom severity of depression at each time point using the following measure:
- Overall Depression Severity and Impairment Scale (ODSIS): 5 item measure assessing for past week depression-related symptoms.
Measured: Administered at each of the following timepoints: baseline, 1-week follow-up, 2-week follow-up, 1-month follow-up, 3-month follow-up, and 6-month follow-up
Changes in suicidal thoughts
To evaluate the efficacy of the Mindful Attention Training (MAT) workshop on the severity and presence of suicidal thoughts at each time point using the following measure:
- Beck Suicide Scale-5 (BSS-5): 5-item measure assessing the presence and intensity of suicidal thoughts.
Measured: Administered at each of the following timepoints: baseline, 1-week follow-up, 2-week follow-up, 1-month follow-up, 3-month follow-up, and 6-month follow-up
Evaluate the feasibility and acceptability of the Mindful Attention Training (MAT) workshop
To evaluate the feasibility and acceptability of the MAT workshop, as compared to waitlist, as defined by: (1) firefighters' self-reported helpfulness of the workshop and (2) firefighters' self-reported efficacy ratings of the workshop using the following measure:
- Post-MAT Workshop Questionnaire (Post-MAT): 10-item questionnaire assessing the degree to which participants found the workshop helpful and tolerable.
Measured: Administered at 1-week follow-up
Changes in anxiety symptoms
To evaluate the efficacy of the Mindful Attention Training (MAT) workshop on the symptom severity of anxiety at each time point using the following measure:
- Overall Anxiety Severity and Impairment Scale (OASIS): 5 item measure assessing for past week anxiety-related symptoms.
Measured: Administered at each of the following timepoints: baseline, 1-week follow-up, 2-week follow-up, 1-month follow-up, 3-month follow-up, and 6-month follow-up
Secondary outcomes (3)
Evaluate group dynamics
To evaluate the group dynamics of the MAT workshop using the following measure:
- Group Evaluation Scale (GES; Joyce, 2005): 7-item measure assessing how the participant felt while participating in the group, particularly comfortability and sense of being understood by other group members.
Measured: Administered at 1-week follow-up
Evaluate group cohesion
To evaluate the cohesion of each group in the MAT workshop using the following measure:
- Group Cohesion Questionnaire (GCQ; MacKenzie, 1983): 12-item measure assessing a participant's view of the cohesion of the group and the quality of the group dynamic.
Measured: Administered at 1-week follow-up
Evaluate occupational stress
To evaluate the influence of the Mindful Attention Training (MAT) workshop on self-reported occupational stress levels at each time point using the following measure:
- The Sources of Occupational Stress (SOOS-14): 14-item self-report measure used to assess levels of occupational stress (i.e., harmful physical and psychological responses that occur when job requirements do not align with the worker's abilities, resources, and/or needs) among firefighters.
Measured: Administered at each of the following timepoints: baseline, 1-week follow-up, 2-week follow-up, 1-month follow-up, 3-month follow-up, and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start5 May 2021
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anka A Vujanovic, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909216
- Sponsor's protocol ID
- STUDY00002213
- Acronym
- HAZMAT
- Status last verified
- May 2023
- First submitted
- 19 May 2021
- Last updated
- 9 May 2023
- Results posted
- No
- 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 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Action Zone - Mindful Attention Training: A Mindfulness-Based Workshop for Firefighters
- ClinicalTrials.gov ID
- NCT04909216
- Acronym / sponsor ID
- HAZMAT / STUDY00002213
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 1 Jun 2021 (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 overarching goal of this study is to demonstrate the efficacy, feasibility, and acceptability of Mindful Attention Training (MAT), a novel mindfulness-based intervention that is specifically developed for firefighters. This project is designed to improve the health of firefighters, an integral, essential component of our national and international communities. Moreover, the study aims to promote health service psychologists by enhancing our contributions to the mental healthcare of firefighters, an understudied and underserved segment of the population by virtue of their service to our communities. This study therefore has significant potential to identify, develop, and promote an effective model of quality, evidence-based mental health promotion and illness prevention by integrating health service psychology into the fire service.
Detailed description
Firefighters are repeatedly exposed to traumatic and stressful situations, increasing their vulnerability for the development of various psychological symptoms and disorders. As many as 32.4% of firefighters meet criteria for posttraumatic stress disorder (PTSD) with significantly more experiencing significant subclinical PTSD symptoms. Approximately 22% of firefighters are also at risk for depression, 46.8% reported serious suicidal ideation, and 15.5% reported having made a suicide attempt during heir firefighter tenure6. Alcohol use disorder (AUD) among firefighters is estimated at approximately 50%, nearly twice that of the general population.
Given the chronically stressful and potentially traumatic nature of the firefighting profession and the high rates of psychological disturbances among firefighters, the development of specialized mental health promotion and illness prevention programs for this vulnerable population is a priority. Mindfulness, generally defined as bringing one's full attention to the present moment and taking a stance of nonjudgmental acceptance to the ongoing flow of sensations, thoughts, and/or emotional states, has significant clinical relevance to the prevention and treatment of various psychological conditions. Mindfulness-based interventions have demonstrated efficacy with regard to various psychological symptoms, including PTSD, depression, and alcohol use. In a military context, mindful attention training has shown promise in terms of reducing the impact of combat on psychological health. However, no specialized mindfulness-based interventions exist for firefighters.
The overarching goal of this study is to demonstrate the efficacy, feasibility, and acceptability of Mindful Attention Training (MAT), a novel mindfulness-based intervention that is specifically developed for firefighters. This project is designed to improve the health of firefighters, an integral, essential component of our national and international communities. Moreover, the study aims to promote health service psychologists by enhancing our contributions to the mental healthcare of firefighters, an understudied and underserved segment of the population by virtue of their service to our communities. This study therefore has significant potential to identify, develop, and promote an effective model of quality, evidence-based mental health promotion and illness prevention by integrating health service psychology into the fire service.
Aim 1: To evaluate the efficacy of the Mindful Attention Training (MAT) workshop, as compared to waitlist comparison ("as usual" condition), on mental health promotion among firefighters, as defined by: self-reported levels of (1a) mindful attention and awareness, (1b) nonjudgmental acceptance, and (1c) nonreactivity at each time point.
Aim 2: To evaluate the efficacy of the MAT workshop, as compared to waitlist, on psychological 'illness' prevention among firefighters, as defined by: self-reported symptom severity of PTSD, depression, anxiety, suicidal ideation, and alcohol use at each time point.
Aim 3: To evaluate the feasibility and acceptability of the MAT workshop, as compared to waitlist, as defined by: (1) firefighters' self-reported helpfulness of the workshop and (2) firefighters' self-reported satisfaction ratings of the workshop.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Attention Workshop | Experimental | Other: Mindful Attention Workshop50 participants will be randomized to the Mindful Attention Training (MAT) workshop. The 90-minute workshop will be conducted in group, online format. |
| Waitlist Control | No intervention | –50 participants will be randomized to the waitlist control condition ("as usual" condition). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 18 years of age
- Current employment as a firefighter with the Houston Fire Department
Key exclusion criteria (4 listed)
- Persons who are not actively employed in the Houston Fire Department (e.g. former firefighters, retired firefighters)
- Current imminent risk of suicidality and/or homicidality (i.e., past month ideation with intent or plan)
- Inability to provide verbal or written consent
- Study personnel will not recruit or screen for individuals who fall into the following categories: pregnant women, prisoners, students for whom study personnel have direct access to/influence on grades, or economically and/or educationally disadvantaged persons
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 |
|---|---|---|
| Mindful Attention WorkshopThe 90-minute workshop will include a 15-minute break and include up to 15 participants. The workshop will be led by peer support staff, fire department psychologists, and/or fire department doctoral psychology practicum students. Each workshop will be facilitate by up to 3 workshop leaders. The workshop will provide (1) psychoeducation regarding common mental health concerns among firefighters, (2) introduction to the concept of mindful attention, why it is relevant to firefighters, and how it can prevent or decrease mental health symptoms, (3) 5 experiential mindful attention training exercises, and (4) discussion. Workshop co-leaders will teach 5 mindful attention exercises, and firefighters will practice each exercise and then engage in discussion about their experiences and provide feedback regarding the utility of the exercise for them personally and for firefighters, generally. | Other | Mindful Attention Workshop |
Primary outcome
Changes in mindfulness
Time frame: Administered at each of the following timepoints: baseline, 1-week follow-up, 2-week follow-up, 1-month follow-up, 3-month follow-up, and 6-month follow-up
To evaluate the efficacy of the Mindful Attention Training (MAT) workshop by examining self-reported levels of (1) nonjudgmental acceptance, (2) nonreactivity as well as (3) psychological resilience and (4) self-compassion at each time point using the following measure: - Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2006): 39-item measure that assesses a participant's capacity for the following five factors: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
Changes in mindful attention
Time frame: Administered at each of the following timepoints: baseline, 1-week follow-up, 2-week follow-up, 1-month follow-up, 3-month follow-up, and 6-month follow-up
To evaluate the efficacy of the Mindful Attention Training (MAT) workshop by examining self-reported levels of mindful attention and awareness at each time point using the following measure: - Mindful Attention Awareness Scale (MAAS; Brown \& Ryan, 2003): 15-item scale assessing a participant's capacity for mindful attention, a key component of mindfulness.
Changes in PTSD symptom severity
Time frame: Administered at each of the following timepoints: baseline, 1-week follow-up, 2-week follow-up, 1-month follow-up, 3-month follow-up, and 6-month follow-up
To evaluate the efficacy of the Mindful Attention Training (MAT) workshop on the symptom severity of PTSD at each time point using the following measure: - Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders (PCL-5): 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of PTSD over the past month.
Changes in hazardous drinking patterns
Time frame: Administered at each of the following timepoints: baseline, 1-week follow-up, 2-week follow-up, 1-month follow-up, 3-month follow-up, and 6-month follow-up
To evaluate the efficacy of the Mindful Attention Training (MAT) workshop on the alcohol use and alcohol use severity at each time point using the following measure: - Alcohol Use Disorders Identification Test (AUDIT): 10-item screening measurement to assess any hazardous and harmful alcohol consumption during the past year.
Changes in depressive symptoms
Time frame: Administered at each of the following timepoints: baseline, 1-week follow-up, 2-week follow-up, 1-month follow-up, 3-month follow-up, and 6-month follow-up
To evaluate the efficacy of the Mindful Attention Training (MAT) workshop on the symptom severity of depression at each time point using the following measure: - Overall Depression Severity and Impairment Scale (ODSIS): 5 item measure assessing for past week depression-related symptoms.
Changes in suicidal thoughts
Time frame: Administered at each of the following timepoints: baseline, 1-week follow-up, 2-week follow-up, 1-month follow-up, 3-month follow-up, and 6-month follow-up
To evaluate the efficacy of the Mindful Attention Training (MAT) workshop on the severity and presence of suicidal thoughts at each time point using the following measure: - Beck Suicide Scale-5 (BSS-5): 5-item measure assessing the presence and intensity of suicidal thoughts.
Evaluate the feasibility and acceptability of the Mindful Attention Training (MAT) workshop
Time frame: Administered at 1-week follow-up
To evaluate the feasibility and acceptability of the MAT workshop, as compared to waitlist, as defined by: (1) firefighters' self-reported helpfulness of the workshop and (2) firefighters' self-reported efficacy ratings of the workshop using the following measure: - Post-MAT Workshop Questionnaire (Post-MAT): 10-item questionnaire assessing the degree to which participants found the workshop helpful and tolerable.
Changes in anxiety symptoms
Time frame: Administered at each of the following timepoints: baseline, 1-week follow-up, 2-week follow-up, 1-month follow-up, 3-month follow-up, and 6-month follow-up
To evaluate the efficacy of the Mindful Attention Training (MAT) workshop on the symptom severity of anxiety at each time point using the following measure: - Overall Anxiety Severity and Impairment Scale (OASIS): 5 item measure assessing for past week anxiety-related symptoms.
3 secondary outcomes
Evaluate group dynamics
Time frame: Administered at 1-week follow-up
Evaluate group cohesion
Time frame: Administered at 1-week follow-up
Evaluate occupational stress
Time frame: Administered at each of the following timepoints: baseline, 1-week follow-up, 2-week follow-up, 1-month follow-up, 3-month follow-up, and 6-month follow-up
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 9 May 2023.
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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 Mindful Attention Workshop in people with Post Traumatic Stress Disorder and Mindfulness, run by University of Houston 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 2 inclusion and 4 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 9 May 2023. 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?
Changes in mindfulness (time frame: Administered at each of the following timepoints: baseline, 1-week follow-up, 2-week follow-up, 1-month follow-up, 3-month follow-up, and 6-month follow-up). The study lists 8 primary outcomes in all. 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 9 May 2023.