N/A
N=116
Meditation Interventions for Treatment of PTSD in Veterans
Stress Disorders, Post-Traumatic
Bottom Line
View on ClinicalTrials.gov: NCT01548742 ↗Enrolled (actual)
116
Serious AEs
2.6%
Results posted
Dec 2015
Primary outcome: Primary: PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up — 63.6; 58.8; 63.9; 61.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness-Based Stress Reduction (MBSR) (Behavioral); Present-Centered Group Therapy (PCGT) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up |
63.6; 58.8; 63.9; 61.7; 61.3; 60.7 | — |
| SECONDARY PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up |
69.9; 62.5; 56.3; 51.7; 49.8; 50.6 | — |
| SECONDARY Depression Symptom Severity on the Patient Health Questionnaire-9 (PHQ-9) at Baseline, After Treatment, and at 2-Month Follow-up |
15.5; 14.6; 13.6; 13.9; 13.3; 13.8 | — |
Summary
Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder which results in serious impairments in interpersonal, occupational and social functioning. Effective treatments are available for PTSD but they do not work for everyone. Alternative treatments are needed to help those veterans not helped by currently available treatments. Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on mindfulness meditation. MBSR has been found to be effective in helping people with problems with pain and anxiety. MBSR has not yet been studied in veterans with PTSD. The proposed study will compare MBSR with a standard psychotherapy treatment in veterans with PTSD. This research is relevant to Veterans' health because of the need to develop alternative treatments for veterans with PTSD who have not responded to currently available treatments.
Eligibility Criteria
Inclusion Criteria
- Male or female veterans who are 18 years or older.
- Must meet current DSM-IV criteria for PTSD based on the Clinician Administered PTSD Scale (CAPS) or have a PTSD Checklist (PCL) score between 40 and 60.
- If taking psychoactive medications, must be on a stable regime for 8 weeks or more.
Exclusion Criteria
- Current suicidal or homicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment.
- Current substance dependence (not in sustained remission), current or recent (within past 6 months) manic episode, or active psychosis. To be eligible, if veteran has current diagnosis of bipolar disorder, there is evidence that illness has been stable for at least 6 months on medication. Has unstable or serious medical illness, including history of stroke, seizure disorder, or unstable cardiac disease that would interfere with participation in treatment.
- Severe cognitive impairment or moderate/severe traumatic brain injury.
- Unable to comprehend or communicate in English.
- Unwilling to accept random assignment or unwilling to refrain from participating in other active forms of psychotherapy during 8-week treatment.
Data sourced from ClinicalTrials.gov (NCT01548742). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.