PTSDNCT02399696
Primary Care-Based Mindfulness Intervention for Veterans With PTSD
A study testing Primary Care-Brief Mindfulness Program and Primary Care-Treatment as Usual in people with PTSD, run by Syracuse VA Medical Center.
Trial summary
Primary care patients typically do not receive adequate PTSD treatment because of their reluctance to engage in empirically-supported treatments offered in specialty care settings. Effective treatments for PTSD are also typically not provided in primary care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- Primary Care-Brief Mindfulness Program and Primary Care-Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Jun 2014
- 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
- 1) sub-threshold or diagnostic level PTSD related to military service as determined by the Clinician Administered PTSD Scale
Who cannot join
- 1) gross cognitive impairment, 2) moderate to severe traumatic brain injury, 3) suicide attempt or intent to commit suicide in the last two months, and 4) receipt of mental healthcare (psychotherapy or medication) outside VA primary in the last two months.
About this study
Primary care patients typically do not receive adequate PTSD treatment because of their reluctance to engage in empirically-supported treatments offered in specialty care settings. Effective treatments for PTSD are also typically not provided in primary care. Brief skill-based treatments offered in primary care may alleviate symptoms and prepare patients to engage in additional treatment. VA primary care patients with PTSD (N=62) were recruited for a randomized clinical trial comparing a Primary Care-Brief Mindfulness Program (PC-bMP) to primary care-treatment as usual (PC-TAU). PC-bMP is a 4-week group program adapted from the 8-week Mindfulness Based Stress Reduction (MBSR) curriculum. Veterans in the PC-bMP condition demonstrated significantly greater decreases in PTSD and depressive symptoms from pre-treatment to post-treatment compared to PC-TAU. These gains were maintained at 8 and 12 week follow-up. PC-bMP participants experienced clinically significant decreases in PTSD, averaging a 15-point drop on the Clinician-Administered PTSD Scale. Exploratory analyses revealed that the describing, non-judging, and acting with awareness facets of mindfulness may account for decreases in PTSD. Our data support preliminary efficacy of a brief mindfulness-based intervention for Veterans with PTSD in primary care. Further research is needed to investigate how PC-bMP may facilitate engagement into full length empirically-supported treatment for PTSD.
- Conditions
- PTSD
- Being tested
- Primary Care-Brief Mindfulness Program, Primary Care-Treatment as Usual
- 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 ProgramBehavioural
A 4-week group program adapted from the 8-week Mindfulness Based Stress Reduction (MBSR) curriculum
Primary Care-Treatment as UsualBehavioural
Typical VA primary care treatment, including mental health services delivered by primary care staff.
| Study group | Role | What they receive |
|---|---|---|
| Primary Care-Brief Mindfulness Program | Experimental | A 4-week group program adapted from the 8-week Mindfulness Based Stress Reduction (MBSR) curriculum. Receives: Behavioral: Primary Care-Brief Mindfulness Program |
| Primary Care-Treatment as Usual | Active comparator | Typical VA primary care treatment, including mental health services delivered by primary care staff. Receives: Behavioral: Primary Care-Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptoms as measured by the PTSD Checklist
Measured: 8 weeks
Secondary outcomes (1)
Depression symptoms as measured by the Patient Health Questionaire-9
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startMar 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syracuse VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Syracuse University
- Responsible party
- Principal investigator, Kyle Possemato, Syracuse VA Medical Center
- Investigators
- Kyle Possemato, Ph.D., Principal investigator, Syracuse VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399696
- Sponsor's protocol ID
- 540
- Status last verified
- Mar 2015
- First submitted
- 23 Mar 2015
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care-Based Mindfulness Intervention for Veterans With PTSD
- ClinicalTrials.gov ID
- NCT02399696
- Acronym / sponsor ID
- 540
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Syracuse VA Medical CenterUS federal agency
- Collaborators
- Syracuse University
- Study start
- Mar 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Mar 2015 (estimated)
- 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.
Primary care patients typically do not receive adequate PTSD treatment because of their reluctance to engage in empirically-supported treatments offered in specialty care settings. Effective treatments for PTSD are also typically not provided in primary care. Brief skill-based treatments offered in primary care may alleviate symptoms and prepare patients to engage in additional treatment. VA primary care patients with PTSD (N=62) were recruited for a randomized clinical trial comparing a Primary Care-Brief Mindfulness Program (PC-bMP) to primary care-treatment as usual (PC-TAU). PC-bMP is a 4-week group program adapted from the 8-week Mindfulness Based Stress Reduction (MBSR) curriculum. Veterans in the PC-bMP condition demonstrated significantly greater decreases in PTSD and depressive symptoms from pre-treatment to post-treatment compared to PC-TAU. These gains were maintained at 8 and 12 week follow-up. PC-bMP participants experienced clinically significant decreases in PTSD, averaging a 15-point drop on the Clinician-Administered PTSD Scale. Exploratory analyses revealed that the describing, non-judging, and acting with awareness facets of mindfulness may account for decreases in PTSD. Our data support preliminary efficacy of a brief mindfulness-based intervention for Veterans with PTSD in primary care. Further research is needed to investigate how PC-bMP may facilitate engagement into full length empirically-supported treatment for PTSD.
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 Program | Experimental | Behavioral: Primary Care-Brief Mindfulness ProgramA 4-week group program adapted from the 8-week Mindfulness Based Stress Reduction (MBSR) curriculum. |
| Primary Care-Treatment as Usual | Active comparator | Behavioral: Primary Care-Treatment as UsualTypical VA primary care treatment, including mental health services delivered by primary care staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) sub-threshold or diagnostic level PTSD related to military service as determined by the Clinician Administered PTSD Scale
Key exclusion criteria (1 listed)
- 1) gross cognitive impairment, 2) moderate to severe traumatic brain injury, 3) suicide attempt or intent to commit suicide in the last two months, and 4) receipt of mental healthcare (psychotherapy or medication) outside VA primary in the last two months.
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 ProgramA 4-week group program adapted from the 8-week Mindfulness Based Stress Reduction (MBSR) curriculum | Behavioural | Primary Care-Brief Mindfulness Program |
| Primary Care-Treatment as UsualTypical VA primary care treatment, including mental health services delivered by primary care staff. | Behavioural | Primary Care-Treatment as Usual |
Primary outcome
PTSD symptoms as measured by the PTSD Checklist
Time frame: 8 weeks
1 secondary outcome
Depression symptoms as measured by the Patient Health Questionaire-9
Time frame: 8 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 31 Mar 2015.
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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
Syracuse VAMC
Questions about this trial
What is this clinical trial studying?
A study testing Primary Care-Brief Mindfulness Program and Primary Care-Treatment as Usual in people with PTSD, run by Syracuse VA Medical Center.
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 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
PTSD symptoms as measured by the PTSD Checklist (time frame: 8 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 31 Mar 2015.