Stress Disorders, Post-TraumaticVMPNCT01548742
Meditation Interventions for Treatment of PTSD in Veterans
A study testing Mindfulness-Based Stress Reduction (MBSR) and Present-Centered Group Therapy (PCGT) in people with Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder which results in serious impairments in interpersonal, occupational and social functioning. Effective treatments are available for PTSD but they do not work for everyone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Mindfulness-Based Stress Reduction (MBSR) and Present-Centered Group Therapy (PCGT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jun 2014
- 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
- Male or female veterans who are 18 years or older.
- Must meet current DSM-IV criteria for PTSD based on the Clinician Administered PTSD Scale (CAPS) or have a PTSD Checklist (PCL) score between 40 and 60.
- If taking psychoactive medications, must be on a stable regime for 8 weeks or more.
Who cannot join
- Current suicidal or homicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment.
- Current substance dependence (not in sustained remission), current or recent (within past 6 months) manic episode, or active psychosis. To be eligible, if veteran has current diagnosis of bipolar disorder, there is evidence that illness has been stable for at least 6 months on medication. Has unstable or serious medical illness, including history of stroke, seizure disorder, or unstable cardiac disease that would interfere with participation in treatment.
- Severe cognitive impairment or moderate/severe traumatic brain injury.
- Unable to comprehend or communicate in English.
- Unwilling to accept random assignment or unwilling to refrain from participating in other active forms of psychotherapy during 8-week treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417
About this study
Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder which results in serious impairments in interpersonal, occupational and social functioning. Effective treatments are available for PTSD but they do not work for everyone. Alternative treatments are needed to help those veterans not helped by currently available treatments. Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on mindfulness meditation. MBSR has been found to be effective in helping people with problems with pain and anxiety. MBSR has not yet been studied in veterans with PTSD. The proposed study will compare MBSR with a standard psychotherapy treatment in veterans with PTSD. This research is relevant to Veterans' health because of the need to develop alternative treatments for veterans with PTSD who have not responded to currently available treatments.
Read the detailed description
Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder associated with high rates of chronicity, poor quality of life, and severe impairments in interpersonal, occupational, and social functioning. While evidence-based psychotherapies for treatment of PTSD have been developed and disseminated within the VA system, no treatment has shown universal effectiveness and there have been great concerns about attenuated treatment response and elevated treatment drop out in veteran populations. The evaluation of alternative treatment modalities for veterans with PTSD is therefore an important priority. The Minneapolis VA Health Care System (MVAHCS) has taught Mindfulness Based Stress Reduction (MBSR), a group-based intervention focused on mindfulness meditation, to veteran clinical populations since 2001, and pilot data from veterans diagnosed with PTSD is promising. Despite support for the application of MBSR to other mental health and physical problems, MBSR has not been systematically evaluated as a treatment for PTSD. Moreover, the existing literature on MBSR is limited by methodological weaknesses. If shown to be efficacious through scientifically sound trials, MSBR may offer an effective, acceptable, and tolerable intervention for veterans suffering PTSD who are unable to engage in or complete traditional exposure-based therapies. The primary goal of this proposal is to conduct a methodologically rigorous randomized controlled trial (RCT) of MBSR in treating PTSD among veterans, examining both symptom outcomes and subsequent health services utilization. Given our compelling pilot data, we propose initial steps to evaluate putative mechanisms of change (self-report and electrophysiology markers, i.e., EEG) through which MBSR may relate to PTSD symptom improvements, and to examine the acceptability of MBSR to the veteran population.
The MVAHCS and the assembled team combines expertise in PTSD treatment and research, clinical trials, and neuroscience, with clinical expertise in MBSR and compelling pilot data to support the feasibility and scope of the current project. The efficacy of MBSR will be examined relative to present-centered group therapy (PCGT), a non-specific therapeutic comparison group. Veterans diagnosed with PTSD will be randomized to MBSR or PCGT for 9 weeks. Each intervention will be delivered in group format following manualization by trained clinicians receiving expert supervision. Treatment integrity will be independently monitored. Assessment of clinical outcomes post-treatment and 2 months follow-up will be independently evaluated. Putative mechanisms of mindfulness meditation will be assessed using self-report and electrophysiology markers. We have the following aims:
Primary Aim 1: To evaluate the efficacy of MBSR as a treatment for PTSD in veterans compared to PCGT over 9-weeks of treatment and 2-month follow-up.
Secondary Aim 1: To identify potential treatment-based predictors of PTSD outcomes.
Secondary Aim 2: To identify differences in subsequent VA health services utilization among veterans across treatment conditions.
Exploratory Aims:
- To evaluate rates of drop-out, compliance, and consumer satisfaction with MBSR.
- To evaluate acceptability and outcomes of treatment with veterans with mild traumatic brain injuries.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Mindfulness-Based Stress Reduction (MBSR), Present-Centered Group Therapy (PCGT)
- Keywords
- Meditation
- 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.
Mindfulness-Based Stress Reduction (MBSR)Behavioural
Also called MBSR
Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
Present-Centered Group Therapy (PCGT)Behavioural
Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Experimental | Mindfulness-Based Stress Reduction (MBSR) Receives: Behavioral: Mindfulness-Based Stress Reduction (MBSR) |
| Arm 2: Present-Centered Group Therapy (PCGT) | Active comparator | Present-Centered Group Therapy (PCGT) Receives: Behavioral: Present-Centered Group Therapy (PCGT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up
The PCL is a valid and reliable measure of PTSD symptoms. Score range from 17-85; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 10 or more points on the PCL.
Measured: Baseline, Weeks 3, 6, 9 and 17
Secondary outcomes (2)
PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up
The CAPS is a valid and reliable measure of PTSD symptom severity. Score range from 0-136; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 10 or more points on the CAPS.
Measured: Baseline, Weeks 9 and 17
Depression Symptom Severity on the Patient Health Questionnaire-9 (PHQ-9) at Baseline, After Treatment, and at 2-Month Follow-up
The PHQ-9 is a valid and reliable measure of depression symptom severity. Score range from 0-27; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 5 or more points on the PHQ-9.
Measured: Baseline, Weeks 9 and 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2014
- Study completionJun 2014
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 (3)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kelvin Lim, MD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548742
- Sponsor's protocol ID
- SPLE-012-11S
- Other IDs
- CX-11-012
- Acronym
- VMP
- Status last verified
- Nov 2015
- First submitted
- 5 Mar 2012
- Last updated
- 10 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Shapira I, Richman J, Pace TWW, Lim KO, Polusny MA, Hamner MB, Bremner JD, Mumba MN, Jacobs ML, Pilkinton P, Davis LL. Biomarker Response to Mindfulness Intervention in Veterans Diagnosed with Post-traumatic Stress Disorder. Mindfulness (N Y). 2022 Oct;13(10):2448-2460. doi: 10.1007/s12671-022-01969-6. Epub 2022 Sep 12.
PubMed 36938380Kang SS, Sponheim SR, Lim KO. Interoception Underlies Therapeutic Effects of Mindfulness Meditation for Posttraumatic Stress Disorder: A Randomized Clinical Trial. Biol Psychiatry Cogn Neurosci Neuroimaging. 2022 Aug;7(8):793-804. doi: 10.1016/j.bpsc.2021.10.005. Epub 2021 Oct 21.
PubMed 34688923Polusny MA, Erbes CR, Thuras P, Moran A, Lamberty GJ, Collins RC, Rodman JL, Lim KO. Mindfulness-Based Stress Reduction for Posttraumatic Stress Disorder Among Veterans: A Randomized Clinical Trial. JAMA. 2015 Aug 4;314(5):456-65. doi: 10.1001/jama.2015.8361.
PubMed 26241597
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditation Interventions for Treatment of PTSD in Veterans
- ClinicalTrials.gov ID
- NCT01548742
- Acronym / sponsor ID
- VMP / SPLE-012-11S
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Mar 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Posted 10 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder which results in serious impairments in interpersonal, occupational and social functioning. Effective treatments are available for PTSD but they do not work for everyone. Alternative treatments are needed to help those veterans not helped by currently available treatments. Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on mindfulness meditation. MBSR has been found to be effective in helping people with problems with pain and anxiety. MBSR has not yet been studied in veterans with PTSD. The proposed study will compare MBSR with a standard psychotherapy treatment in veterans with PTSD. This research is relevant to Veterans' health because of the need to develop alternative treatments for veterans with PTSD who have not responded to currently available treatments.
Detailed description
Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder associated with high rates of chronicity, poor quality of life, and severe impairments in interpersonal, occupational, and social functioning. While evidence-based psychotherapies for treatment of PTSD have been developed and disseminated within the VA system, no treatment has shown universal effectiveness and there have been great concerns about attenuated treatment response and elevated treatment drop out in veteran populations. The evaluation of alternative treatment modalities for veterans with PTSD is therefore an important priority. The Minneapolis VA Health Care System (MVAHCS) has taught Mindfulness Based Stress Reduction (MBSR), a group-based intervention focused on mindfulness meditation, to veteran clinical populations since 2001, and pilot data from veterans diagnosed with PTSD is promising. Despite support for the application of MBSR to other mental health and physical problems, MBSR has not been systematically evaluated as a treatment for PTSD. Moreover, the existing literature on MBSR is limited by methodological weaknesses. If shown to be efficacious through scientifically sound trials, MSBR may offer an effective, acceptable, and tolerable intervention for veterans suffering PTSD who are unable to engage in or complete traditional exposure-based therapies. The primary goal of this proposal is to conduct a methodologically rigorous randomized controlled trial (RCT) of MBSR in treating PTSD among veterans, examining both symptom outcomes and subsequent health services utilization. Given our compelling pilot data, we propose initial steps to evaluate putative mechanisms of change (self-report and electrophysiology markers, i.e., EEG) through which MBSR may relate to PTSD symptom improvements, and to examine the acceptability of MBSR to the veteran population.
The MVAHCS and the assembled team combines expertise in PTSD treatment and research, clinical trials, and neuroscience, with clinical expertise in MBSR and compelling pilot data to support the feasibility and scope of the current project. The efficacy of MBSR will be examined relative to present-centered group therapy (PCGT), a non-specific therapeutic comparison group. Veterans diagnosed with PTSD will be randomized to MBSR or PCGT for 9 weeks. Each intervention will be delivered in group format following manualization by trained clinicians receiving expert supervision. Treatment integrity will be independently monitored. Assessment of clinical outcomes post-treatment and 2 months follow-up will be independently evaluated. Putative mechanisms of mindfulness meditation will be assessed using self-report and electrophysiology markers. We have the following aims:
Primary Aim 1: To evaluate the efficacy of MBSR as a treatment for PTSD in veterans compared to PCGT over 9-weeks of treatment and 2-month follow-up.
Secondary Aim 1: To identify potential treatment-based predictors of PTSD outcomes.
Secondary Aim 2: To identify differences in subsequent VA health services utilization among veterans across treatment conditions.
Exploratory Aims:
- To evaluate rates of drop-out, compliance, and consumer satisfaction with MBSR.
- To evaluate acceptability and outcomes of treatment with veterans with mild traumatic brain injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Experimental | Behavioral: Mindfulness-Based Stress Reduction (MBSR)Mindfulness-Based Stress Reduction (MBSR) |
| Arm 2: Present-Centered Group Therapy (PCGT) | Active comparator | Behavioral: Present-Centered Group Therapy (PCGT)Present-Centered Group Therapy (PCGT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female veterans who are 18 years or older.
- Must meet current DSM-IV criteria for PTSD based on the Clinician Administered PTSD Scale (CAPS) or have a PTSD Checklist (PCL) score between 40 and 60.
- If taking psychoactive medications, must be on a stable regime for 8 weeks or more.
Key exclusion criteria (5 listed)
- Current suicidal or homicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment.
- Current substance dependence (not in sustained remission), current or recent (within past 6 months) manic episode, or active psychosis. To be eligible, if veteran has current diagnosis of bipolar disorder, there is evidence that illness has been stable for at least 6 months on medication. Has unstable or serious medical illness, including history of stroke, seizure disorder, or unstable cardiac disease that would interfere with participation in treatment.
- Severe cognitive impairment or moderate/severe traumatic brain injury.
- Unable to comprehend or communicate in English.
- Unwilling to accept random assignment or unwilling to refrain from participating in other active forms of psychotherapy during 8-week treatment.
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 Stress Reduction (MBSR)Also: MBSRMindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation. | Behavioural | Arm 1: Mindfulness-Based Stress Reduction (MBSR) |
| Present-Centered Group Therapy (PCGT)Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems. | Behavioural | Arm 2: Present-Centered Group Therapy (PCGT) |
Primary outcome
PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up
Time frame: Baseline, Weeks 3, 6, 9 and 17
The PCL is a valid and reliable measure of PTSD symptoms. Score range from 17-85; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 10 or more points on the PCL.
2 secondary outcomes
PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up
Time frame: Baseline, Weeks 9 and 17
Depression Symptom Severity on the Patient Health Questionnaire-9 (PHQ-9) at Baseline, After Treatment, and at 2-Month Follow-up
Time frame: Baseline, Weeks 9 and 17
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36938380Shapira I, Richman J, Pace TWW, Lim KO, Polusny MA, Hamner MB, Bremner JD, Mumba MN, Jacobs ML, Pilkinton P, Davis LL. Biomarker Response to Mindfulness Intervention in Veterans Diagnosed with Post-traumatic Stress Disorder. Mindfulness (N Y). 2022 Oct;13(10):2448-2460. doi: 10.1007/s12671-022-01969-6. Epub 2022 Sep 12.
- Derived from this study: PubMed 34688923Kang SS, Sponheim SR, Lim KO. Interoception Underlies Therapeutic Effects of Mindfulness Meditation for Posttraumatic Stress Disorder: A Randomized Clinical Trial. Biol Psychiatry Cogn Neurosci Neuroimaging. 2022 Aug;7(8):793-804. doi: 10.1016/j.bpsc.2021.10.005. Epub 2021 Oct 21.
- Derived from this study: PubMed 26241597Polusny MA, Erbes CR, Thuras P, Moran A, Lamberty GJ, Collins RC, Rodman JL, Lim KO. Mindfulness-Based Stress Reduction for Posttraumatic Stress Disorder Among Veterans: A Randomized Clinical Trial. JAMA. 2015 Aug 4;314(5):456-65. doi: 10.1001/jama.2015.8361.
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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.
Kelvin Lim, MD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
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 Stress Reduction (MBSR) and Present-Centered Group Therapy (PCGT) in people with Stress Disorders, Post-Traumatic, run by VA Office of Research and Development 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 3 inclusion and 5 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 10 Dec 2015. 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 10 Dec 2015). 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?
PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up (time frame: Baseline, Weeks 3, 6, 9 and 17). 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 NCT01548742, which also lists 3 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 10 Dec 2015.