N/A
N=191
A Multisite Randomized Controlled Trial of Mindfulness Meditation Therapy for PTSD
Posttraumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01532999 ↗Enrolled (actual)
191
Serious AEs
4.2%
Results posted
Apr 2015
Primary outcome: Primary: Change From Baseline in Clinician Administered PTSD Scale — -22.4; -15.9 units on a scale — p=0.5
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness Based Stress Reduction (Behavioral); Present Centered Group Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Clinician Administered PTSD Scale |
-22.4; -15.9 | 0.5 |
| SECONDARY Change From Baseline in PTSD Checklist (PCL) |
-8.6; -6.7 | 0.57 |
| SECONDARY Change From Baseline in Five Facet Mindfulness Questionnaire (FFMQ) |
5.2; 2.1 | — |
| SECONDARY Change From Baseline in Patient Health Questionnaire (PHQ-9) |
-3.2; -1.6 | 0.4 |
| SECONDARY Change From Baseline in CAPS B Subscale |
-7.7; -6.2 | 0.8 |
| SECONDARY Change From Baseline in CAPS C Subscale |
-8.8; -6.8 | 0.4 |
| SECONDARY Change From Baseline in CAPS D Subscale |
-5.9; -3 | 0.35 |
| SECONDARY PTSD Response |
45.2; 37.7 | 0.3 |
| SECONDARY PTSD Remission |
30.7; 27.3 | 0.7 |
Summary
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.
Eligibility Criteria
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 65), prisoners and the terminally ill are excluded.
- Individuals with significant psychotic or dissociative symptoms or severe personality disorder.
Data sourced from ClinicalTrials.gov (NCT01532999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.