- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01532999
A Multisite Randomized Controlled Trial of Mindfulness Meditation Therapy for PTSD
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Tuscaloosa, Alabama, United States, 35404
- Tuscaloosa VA Medical Center, Tuscaloosa, AL
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Georgia
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Decatur, Georgia, United States, 30033
- Atlanta VA Medical and Rehab Center, Decatur, GA
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South Carolina
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Charleston, South Carolina, United States, 29401-5799
- Ralph H. Johnson VA Medical Center, Charleston, SC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Mindfulness Based Stress Reduction
Mindfulness Based Stress Reduction (MBSR) is a 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.
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MBSR is a 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.
Other Names:
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Sham Comparator: Present Centered Group Therapy
Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e.
controls for time, attention, expectation of recovery, and recognition of the illness).
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The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy.
Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e.
controls for time, attention, expectation of recovery, and recognition of the illness).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Clinician Administered PTSD Scale
Time Frame: Baseline to week 9
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Clinician Administered PTSD Scale (CAPS) is a 17-item standard rating scale that measures PTSD severity with scores ranging from 0-136 (higher score = more severe).
Scores of frequency and intensity are summed for the 17-items to yield the total CAPS score.
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Baseline to week 9
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in PTSD Checklist (PCL)
Time Frame: Baseline to week 9
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PTSD Checklist (PCL) is a 17-item self-report scale intended to measure PTSD symptom severity.
The PCL has demonstrated excellent internal consistency (alpha = .94-.97), and test-retest reliability over 2 to 3 days was .96
for Vietnam veterans.
Respondents rate each item from 1 ("not at all") to 5 ("extremely") to indicate the degree to which they have been bothered by that particular symptom over the past month.
Thus, total possible scores (items summed) range from 17 to 85 (higher score is more severe).
A cut-off score of 50 indicates a probable diagnosis of PTSD.
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Baseline to week 9
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Change From Baseline in Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame: Baseline to week 9
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Five Facet Mindfulness Questionnaire (FFMQ) is used to evaluate the effects of MBSR vs. PCGT on mindfulness (S1).
The FFMQ is a 39-item self-report instrument that assesses the general tendency to be mindful in daily life through 5 facets: observing, describing, acting with awareness, non-judging of inner experience, non-reactivity to inner experience.
Increases in FFMQ mediate improvements in well being in observational studies of MBSR.
Each item is rated 1 to 5 ("never or very rarely true" to "very often or always true").
Some of the items are reverse scored (R).
Scoring Information: Observe items:1, 6, 11, 15, 20, 26, 31, 36; Describe items: 2, 7, 12R, 16R, 22R, 27, 32, 37; Act with Awareness items: 5R, 8R, 13R, 18R, 23R, 28R, 34R, 38R; Nonjudge items: 3R, 10R, 14R, 17R, 25R, 30R, 35R, 39R; Nonreact items: 4, 9, 19, 21, 24, 29, 33.
Total all subscales for score (higher score = greater degree of mindfulness).
Score range 39-195 with higher=more mindfulness.
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Baseline to week 9
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Change From Baseline in Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline to week 9
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Patient Health Questionnaire (PHQ-9) is a brief 9-item measure of depressive symptoms that has established reliability and validity in community and clinical populations.
All items are summed for total score ranging from 0 to 27 (higher score = more severe depression).
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Baseline to week 9
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Change From Baseline in CAPS B Subscale
Time Frame: Baseline to week 9
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Clinician Administered PTSD Scale (CAPS) B subscale measures the re-experiencing cluster (i.e.
B criterion) of PTSD symptoms and includes the first 5 items of the CAPS, which is a clinician-administered assessment of posttraumatic stress disorder (PTSD) symptoms.
Frequency and intensity scores for each item is summed for a range of 0 to 40 (higher score = more severe PTSD).
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Baseline to week 9
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Change From Baseline in CAPS C Subscale
Time Frame: Baseline to week 9
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Clinician Administered PTSD Scale (CAPS) C subscale measures the avoidance and emotional numbing cluster (i.e.
C criterion) of PTSD symptoms and includes the items 6 - 12 items of the CAPS, which is a clinician-administered assessment of posttraumatic stress disorder (PTSD) symptoms.
Frequency and intensity scores for each item is summed for a range of 0 to 56 (higher score = more severe PTSD).
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Baseline to week 9
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Change From Baseline in CAPS D Subscale
Time Frame: Baseline to week 9
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Clinician Administered PTSD Scale (CAPS) D subscale measures the hyperarousal cluster (i.e.
D criterion) of PTSD symptoms and includes the items 13 - 17 of the CAPS, which is a clinician-administered assessment of posttraumatic stress disorder (PTSD) symptoms.
Frequency and intensity scores for each item is summed for a range of 0 to 40 (higher score = more severe PTSD).
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Baseline to week 9
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PTSD Response
Time Frame: Baseline to week 9
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Greater than or equal to 30% improvement on PTSD CAPS scale
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Baseline to week 9
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PTSD Remission
Time Frame: Week 9
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Total CAPS score of less than or equal to 45 at week 9 (single observation point)
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Week 9
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Collaborators and Investigators
Investigators
- Principal Investigator: Lori L Davis, MD AB, Tuscaloosa VA Medical Center, Tuscaloosa, AL
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPLE-004-11S
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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