Meditation Interventions for Treatment of PTSD in Veterans

NCT ID: NCT01548742

Last Updated: 2015-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-06-30

Brief 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. 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:

1. To evaluate rates of drop-out, compliance, and consumer satisfaction with MBSR.

2. To evaluate acceptability and outcomes of treatment with veterans with mild traumatic brain injuries.

Conditions

Stress Disorders, Post-Traumatic

Keywords

Meditation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1: Mindfulness-Based Stress Reduction (MBSR)

Mindfulness-Based Stress Reduction (MBSR)

Group Type: EXPERIMENTAL

Mindfulness-Based Stress Reduction (MBSR)

Intervention Type: BEHAVIORAL

Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.

Arm 2: Present-Centered Group Therapy (PCGT)

Present-Centered Group Therapy (PCGT)

Group Type: ACTIVE_COMPARATOR

Present-Centered Group Therapy (PCGT)

Intervention Type: BEHAVIORAL

Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.

Interventions

Mindfulness-Based Stress Reduction (MBSR)

Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.

Intervention Type: BEHAVIORAL

Present-Centered Group Therapy (PCGT)

Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.

Intervention Type: BEHAVIORAL

Other Intervention Names

MBSR

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelvin Lim, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis VA Health Care System, Minneapolis, MN

Locations

VA Medical Center, Minneapolis

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36938380 (View on PubMed)

Kang 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.

Reference Type: DERIVED

PMID: 34688923 (View on PubMed)

Polusny 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.

Reference Type: DERIVED

PMID: 26241597 (View on PubMed)

Other Identifiers

CX-11-012

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SPLE-012-11S

Identifier Type: -

Identifier Source: org_study_id