A Multisite Randomized Controlled Trial of Mindfulness Meditation Therapy for PTSD

Completed · Not applicable

Conditions studied: Posttraumatic Stress Disorder

In brief

Currently, veterans with posttraumatic stress disorder (PTSD) are typically treated with antidepressants which have limited efficacy and yield extremely low remission rates. New and improved treatments are sorely needed, especially in light of the inadequate evidence to support the efficacy of most pharmacologic and most psychotherapy treatments for PTSD. Complementary and Alternative Medicine practices, such as meditation, may fill this void. Several other illnesses often found in association with PTSD, such as chronic pain, anxiety, and depression, have shown positive response to meditation, specifically Mindfulness Based Stress Reduction (MBSR). MBSR is manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes. MBSR is well tolerated, already well disseminated. MBSR has been shown to be effective in reducing conditions that are commonly associated with PTSD, including pain, depression, anxiety and panic, and insomnia. The investigators are conducting a multisite study of Mindfulness Based Stress Reduction (MBSR) compared to Present Centered Group Therapy (PCGT) for the treatment of PTSD. The primary aim of this study will be to determine how well the MBSR form of meditation, i.e. MBSR, works to treat symptoms of PTSD in veterans compared to PCGT. The investigators will evaluate the effects of treatment on levels of mindfulness, depression, PTSD symptom clusters, and response rates. The investigators will evaluate veterans' satisfaction and acceptability of the MBSR intervention. Additionally, biomarkers will be utilized to aid in our understanding of the pathophysiology of meditation and explore the relationship between treatment outcome and neuroimmune response.

Key facts

Study ID: NCT01532999
Run by: US Department of Veterans Affairs
People needed: 254
Starts: 2012-01-01
Expected to finish: 2014-12-01
Last updated by the study team: 2015-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Tuscaloosa VA Medical Center, Tuscaloosa, AL — Tuscaloosa, Alabama, United States
Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States
Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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