Clinical trial NCT01548742: Meditation Interventions for Treatment of PTSD in Veterans
Official title: Meditation Interventions for Treatment of PTSD in Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: Meditation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-03-08
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up
timeFrame: Baseline, Weeks 3, 6, 9 and 17
Secondary outcomes:
measure: PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up
timeFrame: Baseline, Weeks 9 and 17
measure: Depression Symptom Severity on the Patient Health Questionnaire-9 (PHQ-9) at Baseline, After Treatment, and at 2-Month Follow-up
timeFrame: Baseline, Weeks 9 and 17
Other outcomes:
measure: Clinically Significant Improvement in Self-reported PTSD Symptoms as Measured by the PCL
timeFrame: Weeks 9 and 17
measure: Clinically Significant Improvement in Clinician Administered PTSD Scale (CAPS)
timeFrame: Weeks 9 and 17
Locations:
city: Minneapolis
country: United States
facility: VA Medical Center, Minneapolis
state: Minnesota
Study officials:
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
name: Kelvin Lim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.