A Multisite Randomized Controlled Trial of Mindfulness Meditation Therapy for PTSD

NCT01532999 | Completed Results DMC

• 1 other identifier: SPLE-004-11S
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 3

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.

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder; Meditation; Present Centered Group Therapy; mindfulness; MBSR; complementary alternative medicine

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Clinician Administered PTSD Scale

  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.

  Baseline to week 9

Secondary Outcomes (8)

• Change From Baseline in PTSD Checklist (PCL)

  Baseline to week 9

• Change From Baseline in Five Facet Mindfulness Questionnaire (FFMQ)

  Baseline to week 9

• Change From Baseline in Patient Health Questionnaire (PHQ-9)

  Baseline to week 9

• Change From Baseline in CAPS B Subscale

  Baseline to week 9

• Change From Baseline in CAPS C Subscale

  Baseline to week 9

Study Arms (2)

Mindfulness Based Stress Reduction

EXPERIMENTAL

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.

Behavioral: Mindfulness Based Stress Reduction

Present Centered Group Therapy

SHAM COMPARATOR

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

Interventions

Mindfulness Based Stress Reduction BEHAVIORAL

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.

Also known as: MBSR

Mindfulness Based Stress Reduction

Present Centered Group Therapy BEHAVIORAL

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).

Also known as: PCGT

Present Centered Group Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (3)

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Tuscaloosa, Alabama, 35404, United States

Location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

Related Publications (1)

• Shapira I, Richman J, Pace TWW, Lim KO, Polusny MA, Hamner MB, Bremner JD, Mumba MN, Jacobs ML, Pilkinton P, Davis LL. Biomarker Response to Mindfulness Intervention in Veterans Diagnosed with Post-traumatic Stress Disorder. Mindfulness (N Y). 2022 Oct;13(10):2448-2460. doi: 10.1007/s12671-022-01969-6. Epub 2022 Sep 12.

  PMID: 36938380 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Limitations: PCGT may be more active than originally anticipated and is thus an active control rather than neutral control

Results Point of Contact

• Title: Lori L. Davis, MD
• Organization: Tuscaloosa VA Medical Center

lori.davis@va.gov

205-554-2000

Study Officials

• Lori L Davis, MD AB

  Tuscaloosa VA Medical Center, Tuscaloosa, AL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: February 15, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 8, 2015
• Results First Posted: April 8, 2015

Record last verified: 2015-04

Locations

US (3)