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A Multisite Randomized Controlled Trial of Mindfulness Meditation Therapy for PTSD

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01532999
First received: December 8, 2011
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Posttraumatic Stress Disorder
Behavioral: MBSR Meditation
Behavioral: Present Centered Group Therapy (PCGT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multisite Randomized Controlled Trial of Mindfulness Meditation Therapy for PTSD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change from Baseline in Clinician Administered PTSD Scale [ Time Frame: week 9 ] [ Designated as safety issue: No ]
    Clinician Administered PTSD Scale (CAPS) is used to evaluate the efficacy of MBSR in the treatment of PTSD (H1), PTSD symptom clusters (S1), and rates of response (S1). The CAPS is a standard rating scale in PTSD studies; allows us to compare the results of this study to studies of other PTSD interventions for PTSD that used the CAPS, and gives reliable scores for the 3 PTSD symptom clusters for more detailed analysis of the PTSD B, C, and D clusters.


Secondary Outcome Measures:
  • PTSD Checklist (PCL) [ Time Frame: 9 weeks (primary) and 16 weeks outcome (exploratory) ] [ Designated as safety issue: No ]
    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.

  • Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: 9 weeks (primary) and 16 weeks outcome (exploratory) ] [ Designated as safety issue: No ]
    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.

  • Patient Health Questionnaire (PHQ-9) [ Time Frame: baseline, week 3, week 6, week 9 (primary endpoint), week 16 (exploratory) ] [ Designated as safety issue: No ]
    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.

  • WHOQOL-BREF [ Time Frame: baseline, week 9 (primary endpoint), week 16 (exploratory) ] [ Designated as safety issue: No ]
    World Health Organization Quality of Life - Brief (WHOQOL-BREF) is a 26-item brief assessment of quality of life in four factor-analytically confirmed dimensions: Physical, Psychological, Social, and Environmental. The WHOQOL-BREF has good to excellent internal consistency reliability and has shown predicted relationships with health status, single items assessing quality of life, and demographic variables.

  • Credibility/Expectancy Questionnaire (CEQ) [ Time Frame: baseline, week 3, week 6, week 9 (primary endpoint), week 16 (exploratory) ] [ Designated as safety issue: No ]
    The Credibility/Expectancy Questionnaire (CEQ) is an 8 item self-report scale of belief in the rationale and logic of a treatment (credibility) and belief in a likely positive outcome from a treatment (expectancy). The CEQ has been shown to have acceptable internal consistency and test-retest reliability and to predict treatment reactions in expected ways. The CEQ was modified slightly for this protocol to include questions about expectancy regarding changes in trauma symptoms.

  • Sheehan Suicidality Tracking Scale (SSTS) [ Time Frame: baseline, week 3, week 6, week 9, week 16 ] [ Designated as safety issue: Yes ]
    Sheehan Suicidality Tracking Scale (SSTS) evaluates the safety and tolerability of MBRS and PCGT (S2). The SSRS is an 8-item self-report scale; tracks treatment-emergent suicidal ideation (items 2, 3, 4 plus score from item 5 if <1) and behaviors (items 6, 7a, 8, plus item 5 if >1); sensitive to change in frequency or intensity of suicidal thoughts or behaviors over time; maps directly to the suicidality classification coding system used by the FDA. At each assessment visit, the subject completes the SSRS. Positive endorsements are handled by the investigator.

  • The Client Satisfaction Questionnaire-8 (CSQ-8) [ Time Frame: baseline, week 3, week 6, week 9 (primary endpoint), week 16 (exploratory) ] [ Designated as safety issue: No ]
    The Client Satisfaction Questionnaire-8 (CSQ-8) is used to evaluate the subjects' acceptance of and satisfaction with MBSR and PCGT (E4). The CSQ-8 is an 8-item assessment of global satisfaction with a specific treatment. Clients respond on a 5-point Likert scale where 1 is representative of low satisfaction (i.e., quite dissatisfied, poor) and 4 indicates high satisfaction (i.e., very satisfied, excellent).

  • Intent-to-Attend [ Time Frame: baseline, week 3, week 6, week 9, week 16 ] [ Designated as safety issue: No ]
    Intent-to-Attend: a 2-item self-report scale that asks the subject at baseline "How likely is it that you will complete the study?" and asks the subjects at follow-up "How likely is it that you will attend next assessment session?" and scores from zero to 10.

  • Cortisol, interleukin-6, C-reactive protein [ Time Frame: baseline and weeks 3, 9, and 16 ] [ Designated as safety issue: No ]
    Cortisol, interleukin-6, C-reactive protein: All randomized subjects will have blood collected in the morning between 0800 and 1000 at baseline and weeks 3, 9, and 16 for assessment of plasma cortisol, IL-6, and CRP levels to evaluate these biomarkers as they relate to treatment outcome


Estimated Enrollment: 180
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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.
Behavioral: MBSR Meditation
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.
Sham Comparator: Arm 2
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).
Behavioral: Present Centered Group Therapy (PCGT)
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).

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 (<age 19), the elderly (>age 65), prisoners and the terminally ill are excluded.
  • Individuals with significant psychotic or dissociative symptoms or severe personality disorder.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532999

Locations
United States, Alabama
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, United States, 35404
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5799
Sponsors and Collaborators
Investigators
Principal Investigator: Lori Lynne Davis, MD AB Tuscaloosa VA Medical Center, Tuscaloosa, AL
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01532999     History of Changes
Other Study ID Numbers: SPLE-004-11S
Study First Received: December 8, 2011
Last Updated: August 28, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Posttraumatic Stress Disorder
Meditation
Present Centered Group Therapy
mindfulness
MBSR
complementary alternative medicine

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 27, 2014