A Multisite Randomized Controlled Trial of Mindfulness Meditation Therapy for PTSD
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2014 |
| Start Date: | January 2012 |
| End Date: | December 2013 |
| Contact: | Lori L Davis, MD AB |
| Email: | lori.davis@va.gov |
| Phone: | (205) 554-3819 |
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.
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.
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.
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 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 (
- Individuals with significant psychotic or dissociative symptoms or severe personality
disorder.
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