Post Traumatic Stress Disorder (PTSD)NCT06162741
Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans
A study testing Primary Care Brief Mindfulness Training (PCBMT) and Moving Forward (MF) in people with Post Traumatic Stress Disorder (PTSD) and Depression, run by VA Office of Research and Development at 4 sites in United States.
Trial summary
The VA wants to understand what type of integrative and whole health approaches are helpful for Veterans. The study is comparing two primary care based mental health treatments, a mindfulness class that teaches mindfulness meditation and a problem-solving class that teaches problem-solving skills and how to build… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder (PTSD), Depression, Anxiety
- What is being tested?
- Primary Care Brief Mindfulness Training (PCBMT) and Moving Forward (MF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 Aug 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible, participants must be:
- enrolled in VA primary care through the local VA site
- report clinically significant psychological distress as measured in at least one of three areas:
- PTSD operationalized by 30 on the PCL-5 plus endorsing a criteria A stressor
- depression operationalized as 10 on the PHQ-9
- anxiety operationalized by 10 on the GAD-7
Who cannot join
- Exclusion criteria are minimized to allow inclusion of any primary care patients with psychological distress that would normally receive treatment in primary care. Patients will be excluded if they demonstrate symptoms that would not allow them to actively participate in the interventions:
- gross cognitive impairment
- suicide attempt or desire to commit suicide in the last month
- To allow the study to isolate the effects of the intervention and ensure patient treatment preferences are honored, patients will be excluded if they:
- had a psychotherapy appointment outside of primary care within the last month and have future appointment scheduled
- had a change in psychiatric medication outside of VHA primary care in the last 2 months
- voice a preference to be directly referred to specialty mental health care
- Veterans with mild TBI, and alcohol/ substance use disorders will not be excluded because these problems commonly co-occur with psychological distress, and individuals with these conditions have previously benefited from mindfulness and problem-solving training. Patients who receive Primary Care Mental Health Integration (PCMHI) services will not be excluded as this is part of the usual primary care services that all Veterans receive.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ariella Davis contact
United States4 sites, 3 recruiting
- Recruiting
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, 85012
Jenna L Gress-Smith, (480) 397-2927, Jenna.Gress-Smith@va.gov
Jenna L Gress-Smith
- Recruiting
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
Kimberly Savin, PhD, 619-922-4897, Kimberly.Savin@va.gov
Ariella Davis, MSSW, 3158636435, ariella.davis@va.gov
- Recruiting
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, 63106-1621
Abigail E Ramon, (314) 652-4100 ext. 54367, Abigail.Ramon@va.gov
Kathleen Gomathi Raman, MD MPH
- Active, not recruiting
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210-2716
About this study
The VA wants to understand what type of integrative and whole health approaches are helpful for Veterans. The study is comparing two primary care based mental health treatments, a mindfulness class that teaches mindfulness meditation and a problem-solving class that teaches problem-solving skills and how to build resilience, for Veterans who are experiencing symptoms of anxiety, depression, and/or PTSD. The goal of the study is to understand if the classes reduce symptoms of anxiety, depression, and/or PTSD and increase overall functioning.
Read the detailed description
This study seeks to further test the effectiveness of Primary Care Brief Mindfulness Training (PCBMT) across multiple geographically distinct VHA primary care settings that serve diverse Veteran populations and begin to understand important implementation factors with a hybrid type I randomized controlled trial in 300 primary care patients with psychological distress. The study aims include comparing PCBMT to a transdiagnostic problem solving group (Moving Forward, MF) on clinical outcomes, testing mediators and moderators of treatment gain in PCBMT and MF, and assessing implementation barriers and facilitators to inform future implementation efforts. The investigators hypothesize that Veterans randomized to PCBMT will experience larger decreases in psychological distress than participants randomized to MF and changes in transdiagnostic processes will mediate the relationship between changes in mindfulness and psychological distress.
- Conditions
- Post Traumatic Stress Disorder (PTSD), Depression, Anxiety
- Being tested
- Primary Care Brief Mindfulness Training (PCBMT), Moving Forward (MF)
- Keywords
- Psychological Distress, Post Traumatic Stress Disorder (PTSD), Mindfulness, Primary Care, Brief Intervention, Depression, Anxiety, Problem-solving training
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Care Brief Mindfulness Training (PCBMT)Behavioural
Also called PCBMT
PCBMT is a manualized intervention that is a brief adaptation of MBSR Mindfulness Based Stress Reduction (MBSR). It was developed by Dr. Scott Treatman and Dr. Dessa Bergen-Cico (Co-I). PCBMT consists of four 90-minute classes (360 total minutes of classes). Instruction encompasses sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go. In-class meditations are followed by a group process of the experience. At-home practice between sessions is encouraged and is guided by simple checklists asking students to check the meditation they practiced and write a few comments about what the experience was like.
Moving Forward (MF)Behavioural
Also called MF
Moving Forward (MF) is a transdiagnostic class that seeks to build resilience and reduce emotional distress by teaching step-by-step problem-solving skills such as "stop, slow down, think and act". The format that will be used as the comparison is manualized, group-delivered, primary care-based, often co-delivered by MH providers and peers, and considered a usual care practice in many VHA PCMHI programs. MF content is derived from problem solving therapy, which has clear effectiveness in reducing depression and other types of psychological distress. While the MF manual consists of four 60-minutes classes, for this study the 4 classes will be 90-minutes long to equate the length of both conditions. No new content will be added rather the additional time will be used to allow Veterans to complete worksheets in class and allow more group discussion.
| Study group | Role | What they receive |
|---|---|---|
| Primary Care Brief Mindfulness Training (PCBMT) | Experimental | PCBMT is a manualized intervention that is a brief adaptation of MBSR Mindfulness Based Stress Reduction (MBSR). Instruction encompasses sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go. Receives: Behavioral: Primary Care Brief Mindfulness Training (PCBMT) |
| Moving Forward (MF) | Active comparator | Moving Forward (MF) is a transdiagnostic class that seeks to build resilience and reduce emotional distress by teaching step-by-step problem-solving skills such as "stop, slow down, think and act". Receives: Behavioral: Moving Forward (MF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Anxiety and Stress Scale (DASS-21) Change
The Depression Anxiety and Stress Scale (DASS-21) is a widely used measurement for psychological symptoms and distress. It consists of 21 items measured on a 4-point scale. The three subscale scores for depression, anxiety, and stress are also valid measures of their constructs and will be used as secondary outcomes. Depression subscale range: 0-42 with higher scores meaning a worse outcome. Anxiety subscale range: 0-42 with higher scores meaning a worse outcome. Stress subscale range 0-21 with higher scores indicative of greater symptom severity.
Measured: Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks
Secondary outcomes (2)
Satisfaction with Life Scale (SWLS)
Satisfaction with Life Scale (SWLS) is a 5-item scale measuring global judgements of life satisfaction. The possible range of scores is 5-35, with a score of 20 representing a neutral point on the scale. Scores between 5-9 indicate the respondent is extremely dissatisfied with life, whereas scores between 31-35 indicate the respondent is extremely satisfied.
Measured: Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks
PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. PTSD Checklist-5 scale range 0-63 with 63 indicating highest PTSD severity.
Measured: Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start19 Aug 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants in the study are assigned to one of two treatment arms, Primary Care Brief Mindfulness Training (PCBMT) or Moving Forward (MF) transdiagnostic problem-solving therapy, at the beginning of the trial and continue in that arm throughout the length of the trial. Randomization will occur towards the end of the baseline session, at the individual level, at a 1:1 ratio of assignment to PCBMT or MF. Study participants are only exposed to the treatment that is assigned to the particular study arm they are enrolled in.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kyle Possemato, PhD, Principal investigator, Syracuse VA Medical Center, Syracuse, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162741
- Sponsor's protocol ID
- IIR 22-013
- Other IDs
- 1I01HX003626-01A2
- Status last verified
- Aug 2026
- First submitted
- 29 Nov 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final, de-identified datasets will be made available upon PI request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans
- ClinicalTrials.gov ID
- NCT06162741
- Acronym / sponsor ID
- IIR 22-013
- Conditions
- Post Traumatic Stress Disorder (PTSD), Depression, Anxiety
- Keywords
- Psychological Distress, Post Traumatic Stress Disorder (PTSD), Mindfulness, Primary Care, Brief Intervention, Depression, Anxiety, Problem-solving training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Dec 2023 (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 VA wants to understand what type of integrative and whole health approaches are helpful for Veterans. The study is comparing two primary care based mental health treatments, a mindfulness class that teaches mindfulness meditation and a problem-solving class that teaches problem-solving skills and how to build resilience, for Veterans who are experiencing symptoms of anxiety, depression, and/or PTSD. The goal of the study is to understand if the classes reduce symptoms of anxiety, depression, and/or PTSD and increase overall functioning.
Detailed description
This study seeks to further test the effectiveness of Primary Care Brief Mindfulness Training (PCBMT) across multiple geographically distinct VHA primary care settings that serve diverse Veteran populations and begin to understand important implementation factors with a hybrid type I randomized controlled trial in 300 primary care patients with psychological distress. The study aims include comparing PCBMT to a transdiagnostic problem solving group (Moving Forward, MF) on clinical outcomes, testing mediators and moderators of treatment gain in PCBMT and MF, and assessing implementation barriers and facilitators to inform future implementation efforts. The investigators hypothesize that Veterans randomized to PCBMT will experience larger decreases in psychological distress than participants randomized to MF and changes in transdiagnostic processes will mediate the relationship between changes in mindfulness and psychological distress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants in the study are assigned to one of two treatment arms, Primary Care Brief Mindfulness Training (PCBMT) or Moving Forward (MF) transdiagnostic problem-solving therapy, at the beginning of the trial and continue in that arm throughout the length of the trial. Randomization will occur towards the end of the baseline session, at the individual level, at a 1:1 ratio of assignment to PCBMT or MF. Study participants are only exposed to the treatment that is assigned to the particular study arm they are enrolled in.
| Arm | Type | Receives |
|---|---|---|
| Primary Care Brief Mindfulness Training (PCBMT) | Experimental | Behavioral: Primary Care Brief Mindfulness Training (PCBMT)PCBMT is a manualized intervention that is a brief adaptation of MBSR Mindfulness Based Stress Reduction (MBSR). Instruction encompasses sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go. |
| Moving Forward (MF) | Active comparator | Behavioral: Moving Forward (MF)Moving Forward (MF) is a transdiagnostic class that seeks to build resilience and reduce emotional distress by teaching step-by-step problem-solving skills such as "stop, slow down, think and act". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- enrolled in VA primary care through the local VA site
- report clinically significant psychological distress as measured in at least one of three areas:
Key exclusion criteria (8 listed)
- Exclusion criteria are minimized to allow inclusion of any primary care patients with psychological distress that would normally receive treatment in primary care. Patients will be excluded if they demonstrate symptoms that would not allow them to actively participate in the interventions:
- gross cognitive impairment
- suicide attempt or desire to commit suicide in the last month
- To allow the study to isolate the effects of the intervention and ensure patient treatment preferences are honored, patients will be excluded if they:
- had a psychotherapy appointment outside of primary care within the last month and have future appointment scheduled
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 |
|---|---|---|
| Primary Care Brief Mindfulness Training (PCBMT)Also: PCBMTPCBMT is a manualized intervention that is a brief adaptation of MBSR Mindfulness Based Stress Reduction (MBSR). It was developed by Dr. Scott Treatman and Dr. Dessa Bergen-Cico (Co-I). PCBMT consists of four 90-minute classes (360 total minutes of classes). Instruction encompasses sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go. In-class meditations are followed by a group process of the experience. At-home practice between sessions is encouraged and is guided by simple checklists asking students to check the meditation they practiced and write a few comments about what the experience was like. | Behavioural | Primary Care Brief Mindfulness Training (PCBMT) |
| Moving Forward (MF)Also: MFMoving Forward (MF) is a transdiagnostic class that seeks to build resilience and reduce emotional distress by teaching step-by-step problem-solving skills such as "stop, slow down, think and act". The format that will be used as the comparison is manualized, group-delivered, primary care-based, often co-delivered by MH providers and peers, and considered a usual care practice in many VHA PCMHI programs. MF content is derived from problem solving therapy, which has clear effectiveness in reducing depression and other types of psychological distress. While the MF manual consists of four 60-minutes classes, for this study the 4 classes will be 90-minutes long to equate the length of both conditions. No new content will be added rather the additional time will be used to allow Veterans to complete worksheets in class and allow more group discussion. | Behavioural | Moving Forward (MF) |
Primary outcome
Depression Anxiety and Stress Scale (DASS-21) Change
Time frame: Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks
The Depression Anxiety and Stress Scale (DASS-21) is a widely used measurement for psychological symptoms and distress. It consists of 21 items measured on a 4-point scale. The three subscale scores for depression, anxiety, and stress are also valid measures of their constructs and will be used as secondary outcomes. Depression subscale range: 0-42 with higher scores meaning a worse outcome. Anxiety subscale range: 0-42 with higher scores meaning a worse outcome. Stress subscale range 0-21 with higher scores indicative of greater symptom severity.
2 secondary outcomes
Satisfaction with Life Scale (SWLS)
Time frame: Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. Final, de-identified datasets will be made available upon PI request.
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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.
Ariella Davis contact
Kyle Possemato, PhD principal investigator
Syracuse VA Medical Center, Syracuse, NY
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Care Brief Mindfulness Training (PCBMT) and Moving Forward (MF) in people with Post Traumatic Stress Disorder (PTSD) and Depression, run by VA Office of Research and Development at 4 sites 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyle Possemato, PhD ((315) 425-4400 ext. 53551, kyle.possemato@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Anxiety and Stress Scale (DASS-21) Change (time frame: Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks). 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 19 Aug 2026.