Depressive SymptomsNCT05550610
Evaluation of Mindfulness and Yoga in Basic Combat Training
A study testing Mindfulness Based Attention Training (MBAT) and Yoga in people with Depressive Symptoms and Anxiety, run by Walter Reed Army Institute of Research (WRAIR) at 1 site in United States.
Trial summary
The present study is a group randomized trial assessing the impact of mindfulness and yoga training on the health, performance, and well-being of soldiers in Basic Combat Training (BCT). Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Anxiety, Sleep
- What is being tested?
- Mindfulness Based Attention Training (MBAT) and Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,896 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2020to 31 Dec 2021
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- U.S. Army soldiers participating in basic combat training from OCT - DEC 2020 at a U.S. Army installation in the southeastern United States.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The present study is a group randomized trial assessing the impact of mindfulness and yoga training on the health, performance, and well-being of soldiers in Basic Combat Training (BCT). Randomization occurred at the platoon level, and platoons received either a combined mindfulness and yoga regimen or training as usual.
Read the detailed description
This program evaluation assessed a training initiative developed and implemented by the U.S. Army Training and Doctrine Command. Four surveys were conducted with soldiers in all participating platoons over the course of BCT, and two additional surveys were administered with those soldiers in the mindfulness and yoga intervention condition. A follow-up survey was distributed to all participants 6-12 months after BCT. In addition, two surveys were conducted with BCT cadre and drill sergeants. Army data reflecting performance, attrition, and health were also obtained for analysis.
- Conditions
- Depressive Symptoms, Anxiety, Sleep, Emotion Regulation, Pain, Military Operations
- Being tested
- Mindfulness Based Attention Training (MBAT) and Yoga
- Keywords
- military, basic combat training, soldier, drill sergeant, Mindfulness-Based Attention Training
- Medical subject headings
- Depression, Anxiety Disorders, Emotional Regulation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Attention Training (MBAT) and YogaBehavioural
Mindfulness-Based Attention Training (MBAT) was delivered in 4, 2-hour sessions over 4 weeks. Participants also completed 15 minutes of group mindfulness practice 6 days/week and received information on embedded practice during the duty day. Yoga was delivered 6 days/week, 30 minutes per day during warm-up (15 min) and cool-down (15 min) as part of Army physical readiness training.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness and Yoga | Experimental | Mindfulness-Based Attention Training (MBAT) was delivered in 4, 2-hour sessions over 4 weeks. Yoga was delivered 6 days/week, 30 minutes per day. Receives: Behavioral: Mindfulness Based Attention Training (MBAT) and Yoga |
| Training as Usual | No intervention | Training as usual included standard exercises 30 minutes per day during warm-up (15 min) and cool-down (15 min) as part of Army physical readiness training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ) Two-Item Version: Change in Scores Over Time
The PHQ-2 is a validated screening tool for depression. The PHQ-2 included a single item assessing impairment in functioning attributable to reported symptoms.
Measured: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
ICD-10 Musculoskeletal Diagnoses: Occurrence Over Time
ICD-10 musculoskeletal diagnoses (M group) and associated encounter information drawn from U.S. Army records
Measured: 0-10 weeks
Secondary outcomes (23)
Generalized Anxiety Disorder (GAD) Two Item Version: Change Over Time
The GAD-2 is a validated screening tool for anxiety. The GAD-2 included a single item assessing impairment in functioning attributable to reported symptoms.
Measured: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Insomnia Severity Index (ISI): Change Over Time
The ISI is a validated screening tool for insomnia and sleep-related problems.
Measured: 0, 3-4, 6-7, and 9-10 weeks
Pittsburgh Sleep Quality Index (PSQI) Sleep Quality Item: Change Over Time
A single item from the PSQI was used to assess overall sleep quality.
Measured: 0, 3-4, 6-7, and 9-10 weeks
Defense and Veterans Pain Rating Scale (DVPRS): Change Over Time
The DVPRS is a measure of self-reported pain designed for use in military and veteran populations. The DVPRS was adapted for the present study to assess pain-related interference with training, sleep, mood, and stress.
Measured: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Patient Health Questionnaire (PHQ-15): Change Over Time
The PHQ-15 is a validated measure of a range of patient health outcomes. Ten items from the PHQ-15 were used to assess physical pain and assorted medical symptoms.
Measured: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Mental Toughness Inventory (MTI): Change Over Time
The MTI is a measure of mental toughness and resilience. Eight items from the MTI were used in the present evaluation: Four items assessed mental toughness during stressful events, and four items assessed mental toughness following stressful events.
Measured: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Multidimensional Assessment of Interoceptive Awareness (MAIA): Change Over Time
The MAIA is a measure of interoceptive awareness and mindfulness-related constructs. Ten items from the MAIA were used in the present evaluation: Six items assessed the capacity to not self-distract, and four items assessed capacity for self-regulation.
Measured: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Five Facet Mindfulness Questionnaire (FFMQ): Change Over Time
The FFMQ is a measure of engagement in mindful awareness.
Measured: 0, 3-4, 6-7, and 9-10 weeks
Brief Difficulties in Emotion Regulation Scale (DERS): Change Over Time
The Brief DERS is a shortened version of a validated measure assessing ability to manage difficult emotions. Subscales assessed difficulties with emotional awareness, impulse control, and engaging in goal-directed behavior.
Measured: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Attitudes toward Mindfulness Training: Change Over Time
Four items developed for the current evaluation were used to assess perceived acceptability and utility of mindfulness training.
Measured: 0, 3-4, 6-7, and 9-10 weeks
Overall Health: Change Over Time
A single item was used to assess self-rated health.
Measured: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Indiscipline: Occurrence Over Time
Seven items developed for the current evaluation were used to assess behaviors that reflect indiscipline and consequences experienced as a result of indiscipline.
Measured: 3-4, 6-7, and 9-10 weeks
Satisfaction with Yoga or Preparatory and Recovery Drills: Change Over Time
Eleven items developed for this evaluation were used to assess satisfaction with yoga intervention and preparatory and recovery drills.
Measured: 3-4, 6-7, and 9-10 weeks
Unit Cohesion: Change Over Time
A validated three-item measure was used to assess unit cohesion.
Measured: 3-4, 6-7, and 9-10 weeks
Self-Reported Medical Visits: Occurrence Over Time
A single item measure developed for this evaluation was used to assess frequency of medical visits.
Measured: 0, 3-4, 6-7, and 9-10 weeks
Self-Reported Pain: Change Over Time
Three items were developed for this evaluation assessing the frequency of pain, level of pain, and chronicity of pain.
Measured: 0, 3-4, 6-7, and 9-10 weeks
Impact of Injury on Training: Change Over Time
Eight items developed for the present evaluation were used to assess disruption in training due to injury, trainee response to injury, and outcomes associated with experience of injury.
Measured: 3-4, 6-7, and 9-10 weeks
Use of Mindfulness following Training
Twenty-five items were developed for the present evaluation to assess use of mindfulness and attitudes towards mindfulness practice following basic combat training.
Measured: 6-12 month follow-up
Use of Yoga or Preparatory and Recovery Drills (PRT) following Training
Twenty-three items were developed for the present evaluation to assess use of yoga/PRT drills and attitudes towards yoga/PRT drills following basic combat training.
Measured: 6-12 month follow-up
Use of Mindfulness and Yoga Resources following Training
Nine items were developed for this evaluation to assess receipt and use of mindfulness and yoga resources following training.
Measured: 6-12 month follow-up
Use of Mindfulness during Training: Change Over Time
Thirteen items were developed for this evaluation to assess use of MBAT during basic combat training.
Measured: 3-4 weeks; 9-10 weeks
Perceived Drill Sergeant Support for Mindfulness during Training: Change Over Time
Six items were developed for this evaluation to assess trainees' perception of drill sergeant support for MBAT during basic combat training.
Measured: 3-4 weeks; 9-10 weeks
Drill Sergeant Leadership: Change Over Time
Nine items were used to assess participants' perceptions of the quality of drill sergeant's leadership and instruction.
Measured: 3-4 weeks; 9-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start12 Oct 2020
- Primary completion16 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies 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
- Model description
- group randomized trial
- Masking
- None (open label)
- Enrolment
- 1,896 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)
- Sponsor type
- US federal agency
- Collaborators
- U.S. Army Medical Research and Development Command, U.S. Army Training and Doctrine Command (TRADOC)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550610
- Sponsor's protocol ID
- WRAIR #2815
- Status last verified
- Sep 2022
- First submitted
- 2 Aug 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are available for research upon reasonable request and completion of institute-related agreements.
Publications
Nassif TH, Start AR, Toblin RL, Adler AB. Self-reported mindfulness and soldier health following a combat deployment. Psychol Trauma. 2019 May;11(4):466-474. doi: 10.1037/tra0000413. Epub 2018 Nov 5.
PubMed 30394773Janssen M, Heerkens Y, Kuijer W, van der Heijden B, Engels J. Effects of Mindfulness-Based Stress Reduction on employees' mental health: A systematic review. PLoS One. 2018 Jan 24;13(1):e0191332. doi: 10.1371/journal.pone.0191332. eCollection 2018.
PubMed 29364935Domingues RB. Modern postural yoga as a mental health promoting tool: A systematic review. Complement Ther Clin Pract. 2018 May;31:248-255. doi: 10.1016/j.ctcp.2018.03.002. Epub 2018 Mar 10.
PubMed 29705463Jha AP, Stanley EA, Kiyonaga A, Wong L, Gelfand L. Examining the protective effects of mindfulness training on working memory capacity and affective experience. Emotion. 2010 Feb;10(1):54-64. doi: 10.1037/a0018438.
PubMed 20141302Jha AP, Denkova E, Zanesco AP, Witkin JE, Rooks J, Rogers SL. Does mindfulness training help working memory 'work' better? Curr Opin Psychol. 2019 Aug;28:273-278. doi: 10.1016/j.copsyc.2019.02.012. Epub 2019 Mar 6.
PubMed 30999122Zanesco AP, Denkova E, Rogers SL, MacNulty WK, Jha AP. Mindfulness training as cognitive training in high-demand cohorts: An initial study in elite military servicemembers. Prog Brain Res. 2019;244:323-354. doi: 10.1016/bs.pbr.2018.10.001. Epub 2018 Nov 27.
PubMed 30732844Nassif TH, Gutierrez IA, Smith CD, Jha AP, Adler AB. The Effect of a Combined Mindfulness and Yoga Intervention on Soldier Mental Health in Basic Combat Training: A Cluster Randomized Controlled Trial. Depress Anxiety. 2023 Dec 1;2023:6869543. doi: 10.1155/2023/6869543. eCollection 2023.
PubMed 40224611Smith CD, Gutierrez IA, Nassif TH, Jordan KL, Taylor KM, Jha AP, Adler AB. Impact of mindfulness training and yoga on injury and pain-related impairment: a group randomized trial in basic combat training. Front Psychol. 2023 Oct 6;14:1214039. doi: 10.3389/fpsyg.2023.1214039. eCollection 2023.
PubMed 37868598
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mindfulness and Yoga in Basic Combat Training
- ClinicalTrials.gov ID
- NCT05550610
- Acronym / sponsor ID
- WRAIR #2815
- Conditions
- Depressive Symptoms, Anxiety, Sleep, Emotion Regulation, Pain, Military Operations
- Keywords
- military, basic combat training, soldier, drill sergeant, Mindfulness-Based Attention Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,896 participants (actual)
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)US federal agency
- Collaborators
- U.S. Army Medical Research and Development Command, U.S. Army Training and Doctrine Command (TRADOC)
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 16 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 22 Sep 2022 (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 present study is a group randomized trial assessing the impact of mindfulness and yoga training on the health, performance, and well-being of soldiers in Basic Combat Training (BCT). Randomization occurred at the platoon level, and platoons received either a combined mindfulness and yoga regimen or training as usual.
Detailed description
This program evaluation assessed a training initiative developed and implemented by the U.S. Army Training and Doctrine Command. Four surveys were conducted with soldiers in all participating platoons over the course of BCT, and two additional surveys were administered with those soldiers in the mindfulness and yoga intervention condition. A follow-up survey was distributed to all participants 6-12 months after BCT. In addition, two surveys were conducted with BCT cadre and drill sergeants. Army data reflecting performance, attrition, and health were also obtained for analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- group randomized trial
| Arm | Type | Receives |
|---|---|---|
| Mindfulness and Yoga | Experimental | Behavioral: Mindfulness Based Attention Training (MBAT) and YogaMindfulness-Based Attention Training (MBAT) was delivered in 4, 2-hour sessions over 4 weeks. Yoga was delivered 6 days/week, 30 minutes per day. |
| Training as Usual | No intervention | –Training as usual included standard exercises 30 minutes per day during warm-up (15 min) and cool-down (15 min) as part of Army physical readiness training. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- U.S. Army soldiers participating in basic combat training from OCT - DEC 2020 at a U.S. Army installation in the southeastern United States.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Mindfulness Based Attention Training (MBAT) and YogaMindfulness-Based Attention Training (MBAT) was delivered in 4, 2-hour sessions over 4 weeks. Participants also completed 15 minutes of group mindfulness practice 6 days/week and received information on embedded practice during the duty day. Yoga was delivered 6 days/week, 30 minutes per day during warm-up (15 min) and cool-down (15 min) as part of Army physical readiness training. | Behavioural | Mindfulness and Yoga |
Primary outcome
Patient Health Questionnaire (PHQ) Two-Item Version: Change in Scores Over Time
Time frame: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
The PHQ-2 is a validated screening tool for depression. The PHQ-2 included a single item assessing impairment in functioning attributable to reported symptoms.
ICD-10 Musculoskeletal Diagnoses: Occurrence Over Time
Time frame: 0-10 weeks
ICD-10 musculoskeletal diagnoses (M group) and associated encounter information drawn from U.S. Army records
23 secondary outcomes
Generalized Anxiety Disorder (GAD) Two Item Version: Change Over Time
Time frame: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Insomnia Severity Index (ISI): Change Over Time
Time frame: 0, 3-4, 6-7, and 9-10 weeks
Pittsburgh Sleep Quality Index (PSQI) Sleep Quality Item: Change Over Time
Time frame: 0, 3-4, 6-7, and 9-10 weeks
Defense and Veterans Pain Rating Scale (DVPRS): Change Over Time
Time frame: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Patient Health Questionnaire (PHQ-15): Change Over Time
Time frame: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Mental Toughness Inventory (MTI): Change Over Time
Time frame: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Multidimensional Assessment of Interoceptive Awareness (MAIA): Change Over Time
Time frame: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Five Facet Mindfulness Questionnaire (FFMQ): Change Over Time
Time frame: 0, 3-4, 6-7, and 9-10 weeks
Brief Difficulties in Emotion Regulation Scale (DERS): Change Over Time
Time frame: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Attitudes toward Mindfulness Training: Change Over Time
Time frame: 0, 3-4, 6-7, and 9-10 weeks
Overall Health: Change Over Time
Time frame: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up
Indiscipline: Occurrence Over Time
Time frame: 3-4, 6-7, and 9-10 weeks
Satisfaction with Yoga or Preparatory and Recovery Drills: Change Over Time
Time frame: 3-4, 6-7, and 9-10 weeks
Unit Cohesion: Change Over Time
Time frame: 3-4, 6-7, and 9-10 weeks
Self-Reported Medical Visits: Occurrence Over Time
Time frame: 0, 3-4, 6-7, and 9-10 weeks
Self-Reported Pain: Change Over Time
Time frame: 0, 3-4, 6-7, and 9-10 weeks
Impact of Injury on Training: Change Over Time
Time frame: 3-4, 6-7, and 9-10 weeks
Use of Mindfulness following Training
Time frame: 6-12 month follow-up
Use of Yoga or Preparatory and Recovery Drills (PRT) following Training
Time frame: 6-12 month follow-up
Use of Mindfulness and Yoga Resources following Training
Time frame: 6-12 month follow-up
Use of Mindfulness during Training: Change Over Time
Time frame: 3-4 weeks; 9-10 weeks
Perceived Drill Sergeant Support for Mindfulness during Training: Change Over Time
Time frame: 3-4 weeks; 9-10 weeks
Drill Sergeant Leadership: Change Over Time
Time frame: 3-4 weeks; 9-10 weeks
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 22 Sep 2022.
- Background: PubMed 30394773Nassif TH, Start AR, Toblin RL, Adler AB. Self-reported mindfulness and soldier health following a combat deployment. Psychol Trauma. 2019 May;11(4):466-474. doi: 10.1037/tra0000413. Epub 2018 Nov 5.
- Background: PubMed 29364935Janssen M, Heerkens Y, Kuijer W, van der Heijden B, Engels J. Effects of Mindfulness-Based Stress Reduction on employees' mental health: A systematic review. PLoS One. 2018 Jan 24;13(1):e0191332. doi: 10.1371/journal.pone.0191332. eCollection 2018.
- Background: PubMed 29705463Domingues RB. Modern postural yoga as a mental health promoting tool: A systematic review. Complement Ther Clin Pract. 2018 May;31:248-255. doi: 10.1016/j.ctcp.2018.03.002. Epub 2018 Mar 10.
- Background: PubMed 20141302Jha AP, Stanley EA, Kiyonaga A, Wong L, Gelfand L. Examining the protective effects of mindfulness training on working memory capacity and affective experience. Emotion. 2010 Feb;10(1):54-64. doi: 10.1037/a0018438.
- Background: PubMed 30999122Jha AP, Denkova E, Zanesco AP, Witkin JE, Rooks J, Rogers SL. Does mindfulness training help working memory 'work' better? Curr Opin Psychol. 2019 Aug;28:273-278. doi: 10.1016/j.copsyc.2019.02.012. Epub 2019 Mar 6.
- Background: PubMed 30732844Zanesco AP, Denkova E, Rogers SL, MacNulty WK, Jha AP. Mindfulness training as cognitive training in high-demand cohorts: An initial study in elite military servicemembers. Prog Brain Res. 2019;244:323-354. doi: 10.1016/bs.pbr.2018.10.001. Epub 2018 Nov 27.
- Derived from this study: PubMed 40224611Nassif TH, Gutierrez IA, Smith CD, Jha AP, Adler AB. The Effect of a Combined Mindfulness and Yoga Intervention on Soldier Mental Health in Basic Combat Training: A Cluster Randomized Controlled Trial. Depress Anxiety. 2023 Dec 1;2023:6869543. doi: 10.1155/2023/6869543. eCollection 2023.
- Derived from this study: PubMed 37868598Smith CD, Gutierrez IA, Nassif TH, Jordan KL, Taylor KM, Jha AP, Adler AB. Impact of mindfulness training and yoga on injury and pain-related impairment: a group randomized trial in basic combat training. Front Psychol. 2023 Oct 6;14:1214039. doi: 10.3389/fpsyg.2023.1214039. eCollection 2023.
- Individual participant dataSharing planned: No. Data are available for research upon reasonable request and completion of institute-related agreements.
Related trials for Depressive Symptoms
Enrolling by invitation
Efficacy of Repetitive Transcranial Magnetic Stimulation for Improving Depressive Symptoms in Patients With Parkinson's Disease
Parkinson's Disease, Depression
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
Recruiting
Digital Intervention for Physical Activity
Depression - Major Depressive Disorder, Anxiety
Recruiting
SAINT® Therapy for Memory Problems in Older Adults With Treatment-Resistant Depression
Depressive Disorder, Treatment-Resistant, Memory Deficits
Recruiting
The WeACT Program for Family Caregivers of People Living With Dementia
Depression, Caregivers
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 Mindfulness Based Attention Training (MBAT) and Yoga in people with Depressive Symptoms and Anxiety, run by Walter Reed Army Institute of Research (WRAIR) 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 22 Sep 2022. 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?
Patient Health Questionnaire (PHQ) Two-Item Version: Change in Scores Over Time (time frame: 0, 3-4, 6-7, and 9-10 weeks; 6-12 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05550610, which also lists 8 linked publications.
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 22 Sep 2022.