A Multisite Randomized Controlled Trial of Mindfulness Meditation Therapy for PTSD

This study is a prospective, randomized (1:1), controlled multisite study of MBSR in 180 veterans with PTSD. The investigators will compare the clinical outcomes of MBSR to a credible group therapy control condition called Present Centered Group Therapy (PCGT). The investigators will to evaluate the efficacy of MBSR in the treatment of PTSD, as defined by the Clinician Administered PTSD Scale (CAPS), a gold standard measure that is clinically relevant to PTSD. The CAPS will be rated by a trained assessor who is blind to the whether or not the participant receives the MBSR or PCGT intervention. Secondarily, the investigators will evaluate the effects of MBSR on mindfulness, depression, PTSD symptom clusters, rates of response and evaluate the safety and tolerability of MBRS. The investigators will also explore the subjects' acceptance of and satisfaction with MBSR, whether or not the subjects' treatment preference influences outcome; the stress-immunological-biomarkers as they relate to treatment outcome; and the durability of therapeutic effects of MBSR in the treatment of PTSD.

Study Design Overview: Male and female subjects from Active Duty, Reserves, National Guard and/or Veterans with a diagnosis of PTSD will be prospectively randomized 1:1 to receive either MBSR Group therapy or Present Centered Therapy (PCGT) Group (control) for 8 weeks. A cluster of at least 12 participants will be randomized individually to either MBRS or PCGT group therapies, which results in at least 6 participants in each intervention group. A total of 30 groups (15 MBSR Groups and 15 PCGT Groups) are anticipated across three clinical research sites involving at least three different MBSR and three different PCGT instructors/therapists. Outcome assessments (single-blind CAPS and self-report measures) will be obtained at baseline, week 3, week 6, and week 9 (primary endpoint). These assessments will be repeated post-acute treatment at week 16 as an exploratory measure of short-term durability effects.

Inclusion criteria

• Signed and dated informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization form.
• > or = 18 years of age.
• Diagnosis of PTSD (DSM-IV-TR criteria; confirmed by MINI and CAPS).
• Total CAPS score > 45 for the week prior to randomization.
• No substance use disorders (except for nicotine, caffeine) for 2 weeks prior to randomization (Able to Travel to the clinical sites in Tuscaloosa, AL, Atlanta, GA, or Charleston, SC

Exclusion criteria

• Lifetime history of bipolar I, schizophrenia, schizoaffective or cognitive disorders (MINI)
• Actively considering plans of suicide or homicide (assessed by clinical interview)
• Psychotic symptoms that in the investigator's opinion impair the subject's ability to give informed consent and participate in the study interventions
• Severe cognitive disorder (Dementia, severe Traumatic Brain Injury)
• Clinically significant unstable or severe medical condition that would contraindicate study participation or expose them to an undue risk of a significant adverse event.
• In regard to vulnerable patient populations, persons with dementia, minors (<age 19), the elderly (>age 65), prisoners and the terminally ill are excluded.
• Individuals with significant psychotic or dissociative symptoms or severe personality disorder.