N/A
Completed N=184
Loving-Kindness Meditation for PTSD
Source: ClinicalTrials.gov NCT01962714 ↗Enrolled (actual)
184
Serious AEs
4.4%
Results posted
Feb 2020
Primary outcomePrimary: Clinician Administered PTSD Scale (CAPS-5) Score — 25.92; 28.02 units on a scale
Summary
This randomized controlled trial will assess whether a novel complementary and alternative medicines (CAM) intervention, Loving-kindness Meditation (LKM), is not meaningfully inferior to another group-based PTSD treatment , Cognitive Processing Therapy (Cognitive Only version; CPT-C) for reductions in PTSD and depressive symptoms. 170 male and female Veterans with current PTSD will be randomized to LKM or CPT-C. The investigators hypothesize that Veterans randomized to LKM will report mean reductions in PTSD and depressive symptom severity that are not meaningfully worse than CPT-C. The investigators further hypothesize that reductions in posttraumatic maladaptive beliefs will more strongly mediate PTSD and depressive symptom improvement for those assigned to CPT-C than those assigned to LKM.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician Administered PTSD Scale (CAPS-5) Score |
25.92; 28.02 | — |
| PRIMARY NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score |
58.88; 61.22 | — |
Eligibility Criteria
Inclusion Criteria
- Current Diagnostic and Statistical Manual of Mental Disorder (DSM)-5 diagnosis of PTSD,
- 18 or over,
- English fluency,
- Willingness to not participate in Mindfulness-Based Stress Reduction or other meditation programs, as well as Prolonged Exposure (PE) or CPT during the study period.
Exclusion Criteria
- Any of the following substance use criteria: 1) Use in the past 90 days of illicit substance (do not include cannabis)/ street drug (non-prescribed); 2) Use in the past 90 days of prescription drug of abuse, use is not as prescribed AND poses safety concern
- Alcohol involvement that poses a safety concern or is associated with inability to follow through on assessments and class attendance as evinced by current drinking AND dt's or seizure in past year
- Suicidal or homicidal ideation with intent or plan
- Attempted harm to Self or others in the past month
- A lifetime psychotic disorder or current psychotic symptoms
- Uncontrolled bipolar disorder (ie current mania, current hypomania is not an exclusion)
- Chart diagnoses of borderline personality disorder or antisocial personality disorder
- In-patient admission for psychiatric reasons within the past month
- Prior participation in LKM or CPT
- Dementia
Data sourced from ClinicalTrials.gov (NCT01962714). 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. Informational only — not medical advice.