Loving-Kindness Meditation for PTSD

VA Office of Research and Development

Status

Completed

Conditions

Posttraumatic Stress Disorder

Depression

Treatments

Behavioral: Loving-Kindness Meditation

Behavioral: Cognitive Processing Therapy

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01962714

5I01CX000857-02 (U.S. NIH Grant/Contract)

MHBA-006-13S

Details and patient eligibility

About

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.

Full description

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.

Enrollment

184 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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