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NCT01532999 · ClinicalTrials.gov registry record · NA
A Multisite Randomized Controlled Trial of Mindfulness Meditation Therapy for PTSD
A NA study, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- NA
- Development phase
- 254
- Enrollment target
NCT01532999: Completed NA study, sponsored by US Department of Veterans Affairs.
NCT01532999 is a NA study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 254 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01532999, a NA study, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- NA
- Development phase
- 254 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- BEHAVIORAL Mindfulness Based Stress Reduction
- BEHAVIORAL Present Centered Group Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-12 |
| Phase | NA |
What the finished NCT01532999 record still lists
NCT01532999 is an interventional study that assigns participants to a tested intervention. The registered 254 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Mindfulness Based Stress Reduction is the first listed.
NCT01532999 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01532999 about?
NCT01532999 is a clinical study titled "A Multisite Randomized Controlled Trial of Mindfulness Meditation Therapy for PTSD". 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 ...
What is the current status of trial NCT01532999?
This trial is currently completed. It is a NA study. The enrollment target is 254 participants. The study started on 2012-01. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01532999?
The interventions under investigation include: Mindfulness Based Stress Reduction (BEHAVIORAL), Present Centered Group Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01532999?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01532999's enrollment target sits among peer trials
254 407th of 2000 higher than 1,594 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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