Loving-Kindness Meditation for PTSD



Status:Completed
Conditions:Depression, Depression, Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:12/23/2018
Start Date:December 1, 2014
End Date:November 29, 2018

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A Trial of Loving-Kindness Meditation and Cognitive Processing Therapy for PTSD

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.

Aim 1: Evaluate if LKM is non-inferior to CPT-C in producing reductions in PTSD symptoms
among Veterans with current PTSD. Aim 2: Evaluate the non-inferiority of LKM and CPT-C in
producing reductions in depressive symptoms among Veterans with current PTSD. Exploratory
Aim: Evaluate potential mediators of response to LKM and to CPT to provide preliminary
information regarding whether they are consistent with the mechanisms of change
conceptualized by each intervention to be associated with improvement in PTSD and depression.

Methods: A randomized controlled non-inferiority trial comparing LKM to CPT-C. In the
proposed project 170 Veterans with PTSD will be randomized to LKM or CPT-C. Comprehensive
assessments will be performed at baseline as well as at the end of the 12-week interventions
and 3 and 6 months later. PTSD symptoms, depression, posttraumatic maladaptive cognitions and
self-compassion will be assessed weekly during the treatment phase to assess temporality of
change and to assess mediators of outcomes.

Inclusion Criteria:

- Current DMS-V 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
We found this trial at
1
site
Seattle, Washington 98108
Principal Investigator: David J. Kearney, MD
Phone: 206-277-1445
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mi
from
Seattle, WA
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