Clinical trial NCT01532999: A Multisite Randomized Controlled Trial of Mindfulness Meditation Therapy for PTSD
Official title: A Multisite Randomized Controlled Trial of Mindfulness Meditation Therapy for PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Posttraumatic Stress Disorder
Meditation
Present Centered Group Therapy
mindfulness
MBSR
complementary alternative medicine
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-02-15
Enrollment: 254
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: 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.

Detailed description: 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.

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 19), the elderly (\>age 65), prisoners and the terminally ill are excluded.
* Individuals with significant psychotic or dissociative symptoms or severe personality disorder.

Primary outcomes:
measure: Change From Baseline in Clinician Administered PTSD Scale
timeFrame: Baseline to week 9
Secondary outcomes:
measure: Change From Baseline in PTSD Checklist (PCL)
timeFrame: Baseline to week 9
measure: Change From Baseline in Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline to week 9
measure: Change From Baseline in Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline to week 9
measure: Change From Baseline in CAPS B Subscale
timeFrame: Baseline to week 9
measure: Change From Baseline in CAPS C Subscale
timeFrame: Baseline to week 9
measure: Change From Baseline in CAPS D Subscale
timeFrame: Baseline to week 9
measure: PTSD Response
timeFrame: Baseline to week 9
measure: PTSD Remission
timeFrame: Week 9
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Tuscaloosa VA Medical Center, Tuscaloosa, AL
state: Alabama
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
Study officials:
affiliation: Tuscaloosa VA Medical Center, Tuscaloosa, AL
name: Lori L Davis, MD AB
role: PRINCIPAL_INVESTIGATOR
References: