Post-traumatic Stress DisorderNCT03352011
Primary Care Brief Mindfulness Training for Veterans With PTSD
A study testing Primary Care Brief Mindfulness Training and PTSD Psychoeducational Class in people with Post-traumatic Stress Disorder, run by Syracuse VA Medical Center at 1 site in United States.
Trial summary
The proposed study supports a line of research that seeks to improve the health of military veterans with post-traumatic stress disorder (PTSD) by teaching them mindfulness skills. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Primary Care Brief Mindfulness Training and PTSD Psychoeducational Class
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2018to 17 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- enrolled in services at the Syracuse or Canandaigua VAMC and
- report significant PTSD symptoms (qualifying criterion A traumatic event plus at least a 31 on the PCL-5).
Who cannot join
- gross cognitive impairment (>16 on the Blessed OMC),
- suicide attempt or desire to commit suicide in the last month (as measured by P4 screener).
- have received psychotherapy or 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Syracuse Veterans Affairs Medical Center
Syracuse, New York, 13210
About this study
The proposed study supports a line of research that seeks to improve the health of military veterans with post-traumatic stress disorder (PTSD) by teaching them mindfulness skills. The proposed study first gathers Veteran's Affairs mental health provider and peer support specialist feedback to adapt a brief mindfulness intervention and then investigates the feasibility of testing this intervention in a small randomized clinical trial. The study targets primary care patients with PTSD who may be reluctant to engage in other mental health treatments and provides them with mindfulness training to reduce PTSD symptoms, improve psychosocial functioning and increase hope for recovery.
Read the detailed description
Posttraumatic Stress Disorder (PTSD) is highly prevalent in Veterans Affairs (VA) primary care patients (~11.5%) and is associated with significant functional impairment, compromised health, and economic costs. While effective psychotherapies for PTSD are available in VA specialty mental health care settings, primary care patients do not routinely engage in or complete these specialty services. Therefore, alternative delivery models are needed. This proposal integrates two lines of research: mindfulness training and peer support services to test a low-stigma intervention in primary care: Primary Care Based Mindfulness Training (PCBMT). Brief mindfulness training focuses on skill acquisition to help patients manage distress and can serve as a gateway to more intensive treatments for Veterans who are not yet willing to discuss their trauma histories. Peer support specialists help shift treatment away from the medical model focused on symptom reduction to a recovery model focused on leading a meaningful, purposeful life, with or without ongoing illness.
This proposal aims to refine our existing PCBMT to be co-delivered by VA mental health providers and peers and then test important aspects of feasibility to prepare for a future full-scale pragmatic clinical trial. First, VA providers and peers will participate in PCBMT led by study investigators who are certified Mindfulness Based Stress Reduction (MBSR) instructors. Next, study staff will gather feedback from the trained providers and peers for further adaptation and implementation. After this, providers and peers interested in being trained as PCBMT interventionists will be trained by study investigators. Finally, a pilot RCT will be conducted. Both treatments conditions will consist of four, 90-minute group sessions co-facilitated by a VA provider and Veteran peer.
The long-term goal of this research is to improve clinical and personal recovery outcomes for Veterans with PTSD. Our immediate goals are to refine PCBMT based on Veteran, provider, and peer feedback then test the methods needed to conduct a future full-scale RCT, in accordance with the following aims:
- Gather VA mental health provider (n=5) and peer (n=5) feedback to refine PCBMT to a) ensure successful implementation in the VA setting (including creation of a provider manual and standardized provider/peer training curriculum) and b) maximize Veteran skill development to aid in future participation of evidence-based treatment for PTSD.
- Assess the feasibility of conducting a pilot RCT (N=60) comparing PCBMT to a PTSD psychoeducation group on a) rates of recruitment and study retention, b) participant adherence and retention in treatment, provider and peer treatment fidelity, c) participant acceptability (satisfaction, perceived helpfulness) in PCBMT and control condition, and d) measuring outcomes of interest for the future larger trial including: PTSD severity, psychosocial functioning, recovery orientation, active engagement in mental health care.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Primary Care Brief Mindfulness Training, PTSD Psychoeducational Class
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Care Brief Mindfulness TrainingBehavioural
Primary Care Brief Mindfulness Training consists of four 90-minute group classes that teach 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.
PTSD Psychoeducational ClassBehavioural
The PTSD Psychoeducational Class is designed to provide a supportive environment for learning about PTSD-related issues and to help Veterans determine what recovery strategies will be most helpful for them. Session themes include "Civilian Readjustment and PTSD," "Trust, Safety, and Healing" and "Treatment Strategies."
| Study group | Role | What they receive |
|---|---|---|
| Primary Care Brief Mindfulness Training | Experimental | group-based mindfulness training Receives: Behavioral: Primary Care Brief Mindfulness Training |
| PTSD Psychoeducational Class | Active comparator | group-based psychoeducation class Receives: Behavioral: PTSD Psychoeducational Class |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Assessment Retention Assessment Retention
rate of participants who complete all assessment time points
Measured: enrollment to 24 week follow-up
Intervention Retention
rate of participants who complete assigned intervention
Measured: enrollment to 24 week follow-up
Primary Care Brief Mindfulness Fidelity Assessment
Number of essential components of the Primary Care Brief Mindfulness Training curriculum delivered across all 5 cohorts of PCBMT. Number of essential components 0-90. Higher scores indicate more components delivered and better fidelity.
Measured: enrollment to 8 week follow-up
Client Satisfaction Scale
measured by the Client Satisfaction Questionnaire, scale range 1-32 with 32 indicating highest satisfaction.
Measured: 8 week follow-up
Secondary outcomes (5)
Post-traumatic Stress Checklist for DSM-5
PTSD Checklist-5. Scale range 0-63 with 63 indicating highest PTSD severity.
Measured: 24 week follow-up
Recovery Orientation Scale- 24
Recovery Orientation Scale-24 measuring recovery from mental health concerns. Range 24-120, with 120 indicating the greatest amount of recovery.
Measured: 24 week follow-up
Patient Health Questionnaire-9,
Patient Health Questionnaire-9, range 0-27, with 27 indicating the greatest amount of depression.
Measured: 24 week follow-up
Self Compassion Scale- Short Form
Self Compassion Scale- Short Form, range 0-60, with 60 indicating the greatest amount of self compassion.
Measured: 8 week post-treatment
Health Promoting Lifestyle Profile II: Health Responsibility Subscale
Health Promoting Lifestyle Profile II: Health Responsibility. Subscale ranges from 9-36, with 36 indicating the most health responsibility.
Measured: 24 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start2 Jan 2018
- Primary completion10 Feb 2020
- Study completion17 Jun 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syracuse VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Kyle Possemato, Syracuse VA Medical Center
- Investigators
- Kyle Possemato, Ph.D., Principal investigator, VA Center for Intergrated Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352011
- Sponsor's protocol ID
- 1147099-1
- Other IDs
- 5R34AT009678-02
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2017
- Last updated
- 22 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Possemato K, Bergen-Cico D, Buckheit K, Ramon A, McKenzie S, Smith AR, Wade M, Beehler GP, Pigeon WR. Randomized Clinical Trial of Brief Primary Care-Based Mindfulness Training Versus a Psychoeducational Group for Veterans With Posttraumatic Stress Disorder. J Clin Psychiatry. 2022 Dec 28;84(1):22m14510. doi: 10.4088/JCP.22m14510.
PubMed 36576365
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Brief Mindfulness Training for Veterans With PTSD
- ClinicalTrials.gov ID
- NCT03352011
- Acronym / sponsor ID
- 1147099-1
- Conditions
- Post-traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Syracuse VA Medical CenterUS federal agency
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 17 Jun 2020 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Posted 22 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study supports a line of research that seeks to improve the health of military veterans with post-traumatic stress disorder (PTSD) by teaching them mindfulness skills. The proposed study first gathers Veteran's Affairs mental health provider and peer support specialist feedback to adapt a brief mindfulness intervention and then investigates the feasibility of testing this intervention in a small randomized clinical trial. The study targets primary care patients with PTSD who may be reluctant to engage in other mental health treatments and provides them with mindfulness training to reduce PTSD symptoms, improve psychosocial functioning and increase hope for recovery.
Detailed description
Posttraumatic Stress Disorder (PTSD) is highly prevalent in Veterans Affairs (VA) primary care patients (~11.5%) and is associated with significant functional impairment, compromised health, and economic costs. While effective psychotherapies for PTSD are available in VA specialty mental health care settings, primary care patients do not routinely engage in or complete these specialty services. Therefore, alternative delivery models are needed. This proposal integrates two lines of research: mindfulness training and peer support services to test a low-stigma intervention in primary care: Primary Care Based Mindfulness Training (PCBMT). Brief mindfulness training focuses on skill acquisition to help patients manage distress and can serve as a gateway to more intensive treatments for Veterans who are not yet willing to discuss their trauma histories. Peer support specialists help shift treatment away from the medical model focused on symptom reduction to a recovery model focused on leading a meaningful, purposeful life, with or without ongoing illness.
This proposal aims to refine our existing PCBMT to be co-delivered by VA mental health providers and peers and then test important aspects of feasibility to prepare for a future full-scale pragmatic clinical trial. First, VA providers and peers will participate in PCBMT led by study investigators who are certified Mindfulness Based Stress Reduction (MBSR) instructors. Next, study staff will gather feedback from the trained providers and peers for further adaptation and implementation. After this, providers and peers interested in being trained as PCBMT interventionists will be trained by study investigators. Finally, a pilot RCT will be conducted. Both treatments conditions will consist of four, 90-minute group sessions co-facilitated by a VA provider and Veteran peer.
The long-term goal of this research is to improve clinical and personal recovery outcomes for Veterans with PTSD. Our immediate goals are to refine PCBMT based on Veteran, provider, and peer feedback then test the methods needed to conduct a future full-scale RCT, in accordance with the following aims:
- Gather VA mental health provider (n=5) and peer (n=5) feedback to refine PCBMT to a) ensure successful implementation in the VA setting (including creation of a provider manual and standardized provider/peer training curriculum) and b) maximize Veteran skill development to aid in future participation of evidence-based treatment for PTSD.
- Assess the feasibility of conducting a pilot RCT (N=60) comparing PCBMT to a PTSD psychoeducation group on a) rates of recruitment and study retention, b) participant adherence and retention in treatment, provider and peer treatment fidelity, c) participant acceptability (satisfaction, perceived helpfulness) in PCBMT and control condition, and d) measuring outcomes of interest for the future larger trial including: PTSD severity, psychosocial functioning, recovery orientation, active engagement in mental health care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Care Brief Mindfulness Training | Experimental | Behavioral: Primary Care Brief Mindfulness Traininggroup-based mindfulness training |
| PTSD Psychoeducational Class | Active comparator | Behavioral: PTSD Psychoeducational Classgroup-based psychoeducation class |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- enrolled in services at the Syracuse or Canandaigua VAMC and
- report significant PTSD symptoms (qualifying criterion A traumatic event plus at least a 31 on the PCL-5).
Key exclusion criteria (4 listed)
- gross cognitive impairment (>16 on the Blessed OMC),
- suicide attempt or desire to commit suicide in the last month (as measured by P4 screener).
- have received psychotherapy or 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.
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 TrainingPrimary Care Brief Mindfulness Training consists of four 90-minute group classes that teach 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. | Behavioural | Primary Care Brief Mindfulness Training |
| PTSD Psychoeducational ClassThe PTSD Psychoeducational Class is designed to provide a supportive environment for learning about PTSD-related issues and to help Veterans determine what recovery strategies will be most helpful for them. Session themes include "Civilian Readjustment and PTSD," "Trust, Safety, and Healing" and "Treatment Strategies." | Behavioural | PTSD Psychoeducational Class |
Primary outcome
Number of Participants With Assessment Retention Assessment Retention
Time frame: enrollment to 24 week follow-up
rate of participants who complete all assessment time points
Intervention Retention
Time frame: enrollment to 24 week follow-up
rate of participants who complete assigned intervention
Primary Care Brief Mindfulness Fidelity Assessment
Time frame: enrollment to 8 week follow-up
Number of essential components of the Primary Care Brief Mindfulness Training curriculum delivered across all 5 cohorts of PCBMT. Number of essential components 0-90. Higher scores indicate more components delivered and better fidelity.
Client Satisfaction Scale
Time frame: 8 week follow-up
measured by the Client Satisfaction Questionnaire, scale range 1-32 with 32 indicating highest satisfaction.
5 secondary outcomes
Post-traumatic Stress Checklist for DSM-5
Time frame: 24 week follow-up
Recovery Orientation Scale- 24
Time frame: 24 week follow-up
Patient Health Questionnaire-9,
Time frame: 24 week follow-up
Self Compassion Scale- Short Form
Time frame: 8 week post-treatment
Health Promoting Lifestyle Profile II: Health Responsibility Subscale
Time frame: 24 week follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36576365Possemato K, Bergen-Cico D, Buckheit K, Ramon A, McKenzie S, Smith AR, Wade M, Beehler GP, Pigeon WR. Randomized Clinical Trial of Brief Primary Care-Based Mindfulness Training Versus a Psychoeducational Group for Veterans With Posttraumatic Stress Disorder. J Clin Psychiatry. 2022 Dec 28;84(1):22m14510. doi: 10.4088/JCP.22m14510.
- Individual participant dataSharing planned: No
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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.
Kyle Possemato, Ph.D. principal investigator
VA Center for Intergrated Healthcare
1 site 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 and PTSD Psychoeducational Class in people with Post-traumatic Stress Disorder, run by Syracuse VA Medical Center 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 22 Dec 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?
Yes. Results are posted in the registry (first posted 22 Dec 2022). 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?
Number of Participants With Assessment Retention Assessment Retention (time frame: enrollment to 24 week follow-up). The study lists 4 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 NCT03352011, which also lists 1 linked publication.
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 Dec 2022.