Kearney 2021 Oi 210216 1617752043.4612

Original Investigation | Psychiatry
Loving-Kindness Meditation vs Cognitive Processing Therapy

for Posttraumatic Stress Disorder Among Veterans
A Randomized Clinical Trial
David J. Kearney, MD; Carol A. Malte, MSW; Meghan Storms, MSW; Tracy L. Simpson, PhD
Abstract Key Points

Question Is group loving-kindness
IMPORTANCE Additional options are needed for treatment of posttraumatic stress disorder (PTSD)
meditation noninferior to group
among veterans.
cognitive processing therapy for
treatment of posttraumatic stress
OBJECTIVE To determine whether group loving-kindness meditation is noninferior to group
disorder (PTSD) among veterans?
cognitive processing therapy for treatment of PTSD.
Findings In this randomized clinical
DESIGN, SETTING, AND PARTICIPANTS This randomized clinical noninferiority trial assessed PTSD trial, 184 veterans with PTSD were
and depression at baseline, posttreatment, and 3- and 6-month follow-up. Veterans were recruited assigned to group loving-kindness
from September 24, 2014, to February 5, 2018, from a large Veternas Affairs medical center in meditation or group cognitive
Seattle, Washington. A total of 184 veteran volunteers who met Diagnostic and Statistical Manual of processing therapy; the differences in
Mental Disorders (Fifth Edition) criteria for PTSD were randomized. Data collection was completed the decrease from baseline to 6-month
November 28, 2018, and data analyses were conducted from December 10, 2018, to November follow-up for measures of PTSD and
5, 2019. depression were very similar and within
predefined margins considered not
INTERVENTIONS Each intervention comprised 12 weekly 90-minute group sessions. Loving- meaningfully different. Attendance was
kindness meditation (n = 91) involves silent repetition of phrases intended to elicit feelings of better for loving-kindness meditation.
kindness for oneself and others. Cognitive processing therapy (n = 93) combines cognitive
Meaning This study adds to the
restructuring with emotional processing of trauma-related content.
evidence indicating that interventions
without a specific focus on trauma,
MAIN OUTCOMES AND MEASURES Co–primary outcomes were change in PTSD and depression
including meditation-based
scores over 6-month follow-up, assessed by the Clinician-Administered PTSD Scale (CAPS-5; range,
interventions, can yield results similar to
0-80; higher is worse) and Patient-Reported Outcome Measurement Information System (PROMIS;
trauma-focused therapies.
reported as standardized T-score with mean [SD] of 50 [10] points; higher is worse) depression
measures. Noninferiority margins were 5 points on the CAPS-5 and 4 points on the PROMIS
depression measure. + Visual Abstract
RESULTS Among the 184 veterans (mean [SD] age, 57.1 [13.1] years; 153 men [83.2%]; 107 White
+ Supplemental content
Author affiliations and article information are
participants [58.2%]) included in the study, 91 (49.5%) were randomized to the loving-kindness
listed at the end of this article.
group, and 93 (50.5%) were randomized to the cognitive processing group. The mean (SD) baseline
CAPS-5 score was 35.5 (11.8) and mean (SD) PROMIS depression score was 60.9 (7.9). A total of 121
veterans (66%) completed 6-month follow-up. At 6 months posttreatment, mean CAPS-5 scores
were 28.02 (95% CI, 24.72-31.32) for cognitive processing therapy and 25.92 (95% CI, 22.62-29.23)
for loving-kindness meditation (difference, 2.09; 95% CI, −2.59 to 6.78), and mean PROMIS
depression scores were 61.22 (95% CI, 59.21-63.23) for cognitive processing therapy and 58.88
(95% CI, 56.86-60.91) for loving-kindness meditation (difference, 2.34; 95% CI, −0.52 to 5.19). In
superiority analyses, there were no significant between-group differences in CAPS-5 scores, whereas
for PROMIS depression scores, greater reductions were found for loving-kindness meditation vs
(continued)
Open Access. This is an open access article distributed under the terms of the CC-BY License.
JAMA Network Open. 2021;4(4):e216604. doi:10.1001/jamanetworkopen.2021.6604 (Reprinted) April 16, 2021 1/14
Downloaded From: https://jamanetwork.com/ University of Florida by John Ahn on 05/14/2021

JAMA Network Open | Psychiatry Loving-Kindness Meditation vs Cognitive Processing Therapy for PTSD Among Veterans
Abstract (continued)
cognitive processing therapy (for patients attending ⱖ6 visits, ⱖ4-point improvement was noted in
24 [39.3%] veterans receiving loving-kindness meditation vs 9 (18.0%) receiving cognitive
processing therapy; P = .03).
CONCLUSIONS AND RELEVANCE Among veterans with PTSD, loving-kindness meditation resulted
in reductions in PTSD symptoms that were noninferior to group cognitive processing therapy. For
both interventions, the magnitude of improvement in PTSD symptoms was modest. Change over
time in depressive symptoms was greater for loving-kindness meditation than for cognitive
processing therapy.
TRIAL REGISTRATION Clinicaltrials.gov Identifier: NCT01962714
JAMA Network Open. 2021;4(4):e216604. doi:10.1001/jamanetworkopen.2021.6604
Introduction
Military veterans are at increased risk of posttraumatic stress disorder (PTSD) and depression due to
combat1 and other traumas.2 PTSD occurs in 15% to 26% of veterans deployed to Iraq or
Afghanistan,3,4 15% of male Vietnam veterans,5 and 2% to 12% of Gulf War I veterans.6 PTSD
treatment guidelines recommend trauma-focused therapies, including cognitive processing therapy
(CPT) and prolonged exposure, as first-line treatments.7 Despite the proven efficacy and successful
dissemination of CPT and prolonged exposure in Veterans Affairs (VA) health care facilities, only half
or fewer of veterans with PTSD enrolled in the VA seek care,8,9 and most who engage in treatment
receive an inadequate amount of care.9-11 Barriers to PTSD treatment include stigma and concerns
that medications will be required or that talking about trauma will be too difficult.12 New treatments
tailored to patient preferences are necessary to achieve improved outcomes.13,14
Non–trauma-focused treatments can reduce PTSD symptoms.15-22 These interventions do not
elicit trauma-related content but instead teach skills, such as mindfulness or problem-solving, which
can be applied to situations in daily life.16,23 A non–trauma-focused intervention with preliminary
support for treating PTSD24,25 is loving-kindness meditation, a practice intended to increase feelings
of kindness and compassion. Loving-kindness meditation is theorized to increase the ability to
tolerate, rather than avoid, distressing thoughts, images, and feelings and to counteract shame, guilt,
and emotional numbing, which are central symptoms of PTSD24,25 (eAppendix in Supplement 2).
This study tested whether loving-kindness meditation was noninferior to CPT. We hypothesized that
veterans randomized to loving-kindness meditation would show reductions in PTSD and depression
symptoms not meaningfully worse than those assigned to CPT. We also evaluated whether the
proportion of veterans with clinically meaningful change, loss of PTSD diagnostic status, or
attendance rates differed between the 2 treatments.
Methods
Design
This clinical trial, conducted from September 24, 2014, to February 5, 2018, compared veterans
randomly assigned to group-based loving-kindness meditation or group-based CPT-C (cognitive
only) on PTSD and depression outcomes at a large VA medical center serving the Pacific Northwest.
The study was approved by the local institutional review board. All veterans provided written
informed consent. This study followed the Consolidated Standards of Reporting Trials (CONSORT)
reporting guideline.

Participants
Demographic characteristics are shown in Table 1. To better describe the sample, veterans self-
reported race/ethnicity using predefined categories or could choose “other.” Veterans met Diagnostic
and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5) criteria for PTSD26 and agreed to
not participate in mindfulness-based interventions, CPT, or prolonged exposure during the study.
Exclusions were (1) substance use dependence disorder other than alcohol, (2) alcohol use that
posed a safety concern, (3) high risk of suicide, (4) severe psychiatric illness (Supplement 1), or (5)
Table 1. Demographic Characteristics of the Intention-to-Treat Sample
No. (%)a
Characteristic CPT (n = 93) LKM (n = 91)
Age, mean (SD), y 56.1 (13.7) 58.2 (12.5)
Sex
Female 17 (18.3) 13 (14.3)
Male 76 (81.7) 77 (84.6)
Transgender 0 1 (1.1)
Race
Black 20 (21.7) 24 (26.4)
Asian or Pacific Islander 3 (3.3) 3 (3.3)
American Indian 3 (3.3) 0
White 54 (58.7) 53 (58.2)
Other or multiple 12 (13.0) 11 (12.1)
Ethnicity Hispanic or Latino 6 (6.4) 3 (3.3)
Employment
Employed 21 (23.3) 17 (18.7)
Unemployed 5 (5.6) 8 (8.8)
Unemployed due to disability 31 (34.4) 29 (31.9)
Retired 24 (26.7) 33 (36.3)
Student/homemaker 9 (10) 4 (4.4)
Education
High school or less 12 (12.9) 12 (13.2)
Some college 36 (38.7) 45 (49.4)
College degree 45 (48.4) 34 (37.4)
Service-connected disability ≥50% 67 (72.0) 57 (62.6)
Prior mental health or SUD inpatient admission 34 (37.4) 34 (39.1)
Psychotropic medication use at baseline
Antidepressants 51 (54.8) 53 (58.2)
Benzodiazepines 16 (17.2) 10 (11.0)
Other antianxiety medications 13 (14.0) 7 (7.7)
Antipsychotics 16 (17.2) 9 (9.9)
Mood stabilizers 3 (3.2) 2 (2.2)
Type of trauma event
Combat 50 (53.8) 47 (51.6)
Sexual assault or unwanted sexual contact 18 (19.4) 15 (16.5)
Other assault 8 (8.6) 12 (13.2)
Accident 7 (7.5) 5 (5.5)
Sudden death 6 (6.4) 8 (8.8)
Other 4 (4.3) 4 (4.4) Abbreviations: CAPS-5, Clinician-Administered PTSD
Baseline CAPS-5 total score, mean (SD) 35.5 (11.5) 35.5 (12.1) Scale; CPT, cognitive processing therapy; PROMIS,
Baseline PROMIS depression T-score, mean (SD) 60.5 (7.6) 61.3 (8.2) Patient-Reported Outcomes Measurement
Information System; PTSD, posttraumatic stress
Treatment session attendance
disorder; SUD, substance use disorder.
Total study treatment sessions, mean (SD)b 6.0 (4.6) 7.4 (4.2) a
Values are expressed as No. (%) unless otherwise
Attended ≥6 treatment sessions 50 (53.8) 61 (67.0)
specified.
Other mental health visits (baseline to 6-mo follow-up), mean (SD) 6.4 (9.3) 7.1 (10.2) b
P < .05.

prior participation in loving-kindness meditation or CPT. Medication and supportive counseling were
allowed throughout the study.
Procedures
Recruitment consisted primarily of mailings to veterans with a diagnosis of PTSD who received VA
care, as identified via VA databases. A telephone screen was followed by a 2-hour in-person baseline
assessment. Twelve cohorts of 10 to 21 veterans were randomized every 3 to 4 months from
September 24, 2014, to February 5, 2018. Figure 1 illustrates recruitment and retention. Participants
completed assessments at posttreatment and 3-month and 6-month follow-ups and received $20
to $50 for each assessment.
Randomization
Random permuted block randomization (blocks of 2, 4, or 6 individuals) stratified by symptom
severity per the Clinician-Administered PTSD Scale (CAPS-5, score ⱖ37) with masked allocation using
sequentially numbered opaque envelopes was performed. The CAPS-5 score was calculated by
summing severity scores for the 20 DSM-5 PTSD symptoms. A symptom was considered present if
the severity was 2 (moderate) or higher. A PTSD diagnosis required at least 1 symptom for both
criteria B and C, at least 2 symptoms for both criteria D and E, and meeting criteria F and G. A staff
Figure 1. Consolidated Standards of Reporting Trials (CONSORT) Flow Diagram
522 Assessed through a telephone screening interview
310 Excluded
111 Failed to attend baseline appointment
53 Ineligible due to current or prior treatment (previous LKM
or CPT treatment, enrolled in another interventional study,
unwilling to refrain from engaging in MBSR, or enrolled
in prolonged exposure therapy during study period)
48 Ineligible due to current mental health diagnosis (psychotic
disorder, borderline personality disorder, antisocial personality
disorder, or dementia)
27 Did not think the study was a good fit for other reasons
21 Current substance use disorder other than alcohol or marijuana
13 High risk of harm to self or others (past 30 d attempted
harm to self or others, past 30 d more than 1 suicide risk
assessment, or current suicide risk flag)
11 Inpatient admission for psychiatric reasons within past month
10 No PTSD diagnosis
7 Unwilling to participate in randomly assigned program
6 Other
2 No reason listed
1 Difficulty completing questionnaires
212 Assessed through baseline clinical evaluation
28 Ineligible
21 High risk of harm to self or others (as defined by “moderate risk”
or higher score on suicide risk assessment)
4 Current drug use (except alcohol and marijuana)
2 No PTSD diagnosis or no active symptoms
1 Did not think study was a good fit for other reasons
184 Randomized
91 Assigned to LKM 93 Assigned to CPT

61 Attended 6+ sessions (67%) 50 Attended 6+ sessions (54%)
63 Attended post follow-up (69%) 57 Attended post follow-up (61%)
58 Attended 3-mo follow-up (63%) 56 Attended 3-mo follow-up (61%)
61 Attended 6-mo follow-up (67%) 60 Attended 6-mo follow-up (66%)
CPT indicates cognitive processing therapy; LKM, loving-kindness meditation; MBSR, mindfulness-based stress reduction.

member not involved in recruitment constructed randomization lists using the random number
generator feature of Excel (Microsoft Corp).27
Study Therapists
Loving-kindness meditation groups were co-led by 2 community meditation teachers with
experience teaching mindfulness and loving-kindness meditation to veterans. A study team member
(D.J.K.) with experience teaching loving-kindness meditation provided supervision. CPT groups were
co-led by 2 master’s-level therapists who had completed training and certification in CPT through
the VA. They received supervision by an experienced CPT national trainer.
Treatment Conditions
Each intervention consisted of 12 weekly 90-minute group sessions including male and female
veterans. The study design provided parity in number of treatment hours, treatment sessions, and
the number and allegiance of facilitators and therapists across conditions.
Loving-Kindness Meditation
The loving-kindness meditation curriculum is based on the formulation described by Salzberg.28 In
loving-kindness meditation, one calls to mind a particular person (eg, a good friend) and silently
repeats phrases that invoke goodwill, such as “may you be safe,” “may you be happy,” and “may you
be healthy.” The practice gradually expands to include oneself and those who have caused difficulty
or harm.28 Veterans were asked to notice thoughts and feelings elicited by the phrases with an
attitude of kindness, curiosity, and nonjudgment, regardless of content. Class sessions began with a
brief mindfulness (weeks 1 and 2) or loving-kindness (weeks 3 through 12) meditation followed by
discussion and additional loving-kindness meditation practice. Educational materials describing the
relationship between meditation, PTSD, and depression were provided. Homework consisted of 30
minutes of meditation 6 days per week using compact discs and informal loving-kindness meditation
practices in daily life.
CPT (Cognitive Only)

CPT-C is based on Resick and colleagues’ manual for treating PTSD among military veterans, which
combines cognitive restructuring with emotional processing of trauma-related content29 but does
not include writing a trauma narrative.30 Sessions initially focus on rigid or inaccurate beliefs about
the traumatic event, which often reflect self-blame or hindsight bias. Later sessions address trauma-
related, overgeneralized beliefs about self and others relevant to 5 key areas: safety, trust, power,
esteem, and intimacy. Participants learn to identify and modify their beliefs to become more
balanced, flexible, and adaptive. Homework, conducted for 30 minutes 6 days per week, consisted
of completing worksheets and exercises as well as writing an impact statement at the beginning and
end of treatment.
Measures
PTSD severity and diagnostic status were assessed using the 30-item CAPS-5 (score range, 0-80;
higher scores indicate more severe PTSD) structured interview31 with lifetime number and type of
traumatic events assessed via the 17-item Life Events Checklist.32 The CAPS-5 has strong
psychometric properties.31 A clinician (M.S.) masked to the randomization arm conducted the
interviews. Depression was assessed using the Patient-Reported Outcomes Measurement
Information System (PROMIS) depression measure (PROMIS scores are reported as a standardized
T-score, which represents a mean [SD] of 50 [10] points; higher scores indicate worse depression),33
which has high internal consistency (Cronbach α = 0.979)34 and precision. Other VA mental health
care received by participants between baseline and 6-month follow-up was extracted from VA
databases, and days of mental health treatment received for each treatment arm were calculated.

Outcomes
The primary outcome of noninferiority of loving-kindness meditation relative to CPT-C was assessed
using a noninferiority margin of 5 points on the CAPS-5, which represents 0.5 SD of baseline PTSD
symptoms based on data from a large sample (N = 198) of treatment-seeking veterans (B.P. Marx,
MD, email communication, 2019). An effect size of Cohen d = 0.5 has been defined as the minimally
important difference in prior PTSD trials.35-37 The proportion of participants with clinically
meaningful improvement or worsening of PTSD symptoms was assessed using both stringent (ⱖ10
points) and less stringent (ⱖ5 points) criteria. Loss of PTSD diagnostic status was calculated as the
proportion no longer meeting DSM-5 criteria,26 and full remission was calculated as the proportion
with a CAPS-5 score less than 12.38 For depression, the noninferiority margin was 4 points on the
PROMIS depression measure, which is defined as the minimally important difference and represents
a Cohen d effect size of approximately 0.50.39-41 The proportion with clinically meaningful
improvement or worsening of depressive symptoms was assessed using stringent (ⱖ8 points) and
less stringent (ⱖ4 points) criteria.
Treatment Fidelity and Adverse Events

All sessions were recorded, and a random subset (20%) was coded for adherence, competence, and
proscribed elements by 2 independent raters. Training on loving-kindness meditation fidelity coding
was provided by a study team member (D.J.K.), and training on CPT-C fidelity coding was provided by
a psychologist with extensive experience coding CPT. For loving-kindness meditation, 92.8% of
essential elements were delivered, and there were no proscribed elements. Competence in loving-
kindness meditation delivery was rated on a 7-point scale (7 = excellent, 4 = satisfactory), with a
mean (SD) competence score of 5.4 (0.5) or “good”; 96.3% of the elements were rated “satisfactory”
or better. For CPT, 98.4% of unique and essential elements were included in all sessions, and there
were no proscribed elements. Competence of CPT delivery was rated on a 5-point scale
(5 = excellent, 3 = satisfactory); the mean (SD) therapist competence score was 4.0 (0.5) or “good,”
and 97% of all elements were rated “satisfactory” or better. Adverse events were prospectively
monitored, including hospitalizations, suicidality, death, and a prespecified level of increase in PTSD
or depression score.
Statistical Analysis
Data collection was completed November 28, 2018, and data analyses were conducted from
December 10, 2018, to November 5, 2019. Sample size was determined using Stata, version 15
(StataCorp LLC) using the SSI module for noninferiority trials.42 For CAPS-5 severity scores, a
noninferiority margin of 5 points, SD of 10, a 1-sided α of 0.025,36 power of 0.80, and equal allocation
of participants between treatments indicated that 63 patients per randomization arm were needed.
To protect against an anticipated attrition rate of 26%, the sample was inflated to 170 patients.
Characteristics of veterans who completed half or more of the treatment sessions were compared
with those who did not using χ2 analysis and t tests for categorical and continuous data, respectively.
Noninferiority was assessed using linear mixed models that included treatment condition, time
(baseline, posttreatment, 3 months, and 6 months), and time by treatment interaction as fixed
effects. Because outcomes were highly correlated for both the loving-kindness meditation (intraclass
correlation coefficient [ICC], 0.55; 95% CI, 0.41-0.68) and CPT-C (ICC, 0.58; 95% CI, 0.46-0.70) at
the individual level, a patient identifier was included as a random effect to account for correlated
outcomes over time. Correlation at the group cohort level was found to be minimal and not included
in the final models. Age, sex, trauma type, and baseline PROMIS depression and CAPS-5 scores for
the PTSD and depression noninferiority models, respectively, were included as covariates. A patient
identifier was included as a random effect to account for correlated outcomes over time (ICC, 0.44;
95% CI, 0.22-0.68 and 0.45; 95% CI, 0.28-0.62 in the loving-kindness meditation and CPT-C arms,
respectively). The noninferiority of loving-kindness meditation with respect to CPT-C was analyzed
using the 95% CI for the group × time interaction term, with noninferiority of loving-kindness

meditation to CPT-C claimed if the lower limit of the 95% CI was greater than –δ. Analyses were
performed using both intention-to-treat (ITT) and completer (those attending ⱖ6 sessions of loving-
kindness meditation or CPT-C) samples given that ITT analyses may bias results toward
noninferiority,43 with noninferiority claimed if both completer and ITT analyses demonstrated
noninferiority36,43 at the 6-month time point. If noninferiority was shown, as part of the analytic plan
for the primary aim, we assessed superiority using the group × time interaction term from the linear
mixed models described previously, with a 2-sided α of .05 considered significant.44,45
Between- and within-group effect sizes based on the previously mentioned models were
calculated as Cohen d. Proportions with clinically meaningful change, full remission, and no longer
meeting DSM-5 criteria were compared using χ2 tests. Veterans with missing data were coded as not
demonstrating clinically meaningful change and as retaining diagnostic status. All analyses were
completed in Stata, version 15 (StataCorp LLC).
Results
Among the 184 veterans (mean [SD] age, 57.1 [13.1] years; 153 men [83.2%]; 107 White participants
[58.2%]) included in the study, 91 (49.5%) were randomized to the loving-kindness group, and 93
(50.5%) were randomized to the cognitive processing group. PTSD and depression symptom
severity were similar at baseline across the 2 conditions (Table 1). The mean number of treatment
sessions completed was lower in CPT than in loving-kindness meditation (mean [SD] sessions, 6.01
[4.6] vs 7.40 [4.2], respectively; P = .03). Veterans who completed 6 or more sessions (n = 111) were
older (ⱖ6 sessions, mean [SD] age, 59.4 [12.3] years; <6 sessions, 53.7 [13.7] years; P = .004) and
had greater baseline depression (ⱖ6 sessions, mean [SD], 69.6 [7.3]; <6 sessions, 62.9
[8.3]; P = .005).
Table 2 shows estimated means over time for CAPS-5 and PROMIS depression scores.
Differences in mean scores at each time point for primary outcomes in relation to the noninferiority
margin are illustrated in Figure 2 and the eFigure in Supplement 2. The mean (SD) baseline CAPS-5
score was 35.5 (11.8), and the mean (SD) PROMIS depression score was 60.9 (7.9). A total of 121
(66%) veterans completed 6-month follow-up. At 6 months posttreatment, mean CAPS-5 scores
Table 2. Estimated Outcome Measures by Condition and Time Pointa
Estimated mean (95% CI)

Outcome measure Patient No. Baseline End of treatment 3-mo follow-up 6-mo follow-up
ITT
CAPS-5 scoreb 183
CPT 93 35.18 (32.94-37.42) 29.47 (26.77-32.17) 29.09 (26.16-32.01) 28.02 (24.72-31.32)
LKM 90 34.99 (32.72-37.26) 29.35 (26.70-31.99) 28.12 (25.20-31.04) 25.92 (22.62-29.23)
PROMIS depression T-scorec 184
CPT 93 60.43 (59.08-61.79) 61.25 (59.58-62.93) 62.06 (60.27-63.86) 61.22 (59.21-63.23)
LKM 91 61.27 (59.89-62.64) 58.46 (56.84-60.07) 59.1 (57.33-60.88) 58.88 (56.86-60.91)
Participants completing ≥6 treatment sessions
CAPS-5 score 110
CPT 50 33.73 (30.67-36.78) 27.53 (24.27-30.79) 27.50 (23.96-31.04) 27.70 (23.63-31.77)
LKM 60 34.36 (31.58-37.14) 29.20 (26.19-32.20) 28.30 (24.94-31.65) 25.76 (21.92-29.60)
PROMIS depression T-scorec 111
CPT 50 59.60 (57.88-61.32) 60.79 (58.93-62.66) 61.16 (59.13-63.19) 60.46 (58.21-62.71)
LKM 61 59.74 (58.18-61.30) 57.14 (55.44-58.84) 58.09 (56.17-60.01) 56.93 (54.79-59.08)
Abbreviations: CAPS-5, Clinician-Administered PTSD Scale; CPT, cognitive processing therapy; ITT, intention to treat; LKM, loving-kindness meditation; PROMIS, Patient-Reported
Outcomes Measurement Information System; PTSD, posttraumatic stress disorder.
a
Data from 1 veteran are missing from the PTSD models because the subject did not complete the PROMIS depression at baseline, which is a covariate.
b
Adjusted for sex, age, baseline PROMIS depression T-score, and trauma type.
c
Adjusted for sex, age, baseline CAPS-5 score, and trauma type.

were 28.02 (95% CI, 24.72-31.32) for CPT and 25.92 (95% CI, 22.62-29.23) for loving-kindness
meditation (difference, 2.09; 95% CI, −2.59 to 6.78), and mean PROMIS depression scores were
61.22 (95% CI, 59.21-63.23) for CPT and 58.88 (95% CI, 56.86-60.91) for loving-kindness meditation
(difference, 2.34; 95% CI, −0.52 to 5.19). In completer models, the differences in decrease were 1.94
(95% CI, −3.70 to 7.59) for CAPS-5 scores and 3.52 (95% CI, 0.39 to 6.66) for PROMIS depression
scores. The lower bound of the 95% CI of the difference between treatments was greater than the
noninferiority margin for both CAPS-5 and PROMIS depression in ITT and completer analyses at
6-month follow-up, indicating that the comparisons met criteria for noninferiority. In superiority
analyses, for CAPS-5 score, the group × time interaction term was not significant at any time point in
both ITT and completer analyses. For PROMIS depression scores, in ITT analyses, the group × time
interaction was significant at the posttreatment (β = 3.63; 95% CI, 1.23-6.04 points; P = .003),
3-month (β = 3.79; 95% CI, 1.22-6.36 points; P = .004), and 6-month (β = 3.17; 95% CI, 0.31-6.04
points; P = .03) visits, indicating superiority of loving-kindness meditation to CPT. Effect sizes ranged
from 0.35 at posttreatment to 0.24 at 6 months, indicating a small effect. Completer analyses
showed similar results with a significant group × time interaction at posttreatment (β = 3.79; 95% CI,
1.10-6.48 points; P = .006), 3-month (β = 3.21; 95% CI, 0.39-6.03 points; P = .03), and 6-month
(β = 3.66; 95% CI, 0.70-6.62; P = .02) visits. Effect sizes were slightly larger, ranging from 0.54 at
posttreatment to 0.42 at 6 months, indicating a small to medium effect. These findings indicate
greater improvement in depression symptoms but not PTSD symptoms from baseline to follow-up
for loving-kindness meditation relative to CPT.
The CAPS-5 within-condition effect sizes at 6 months were medium for CAPS-5 for loving-
kindness meditation (d = 0.66; 95% CI, 0.36-0.96) and CPT (d = 0.52; 95% CI, 0.22-0.81) in ITT
analyses, whereas between-condition effect sizes included 0 (d = 0.13; 95% CI, –0.16 to 0.42). Similar
findings were seen in CAPS-5 completer analyses. For PROMIS depression, within-condition effect
sizes for both loving-kindness meditation (d = 0.28; 95% CI, –0.01 to 0.58) and CPT (d = 0.09; 95%
CI, –0.38 to 0.19) included 0 at 6 months in ITT analyses, as did between-condition effect sizes
(d = 0.24; 95% CI, –0.05 to 0.53). For PROMIS depression completer analyses, within-condition
effect sizes at 6 months were small to medium for loving-kindness meditation (d = 0.38; 95% CI,
0.02-0.73) and included 0 for CPT (d = –0.12; 95% CI, –0.51 to 0.27). Between-condition effect sizes
demonstrated a medium effect favoring loving-kindness meditation (d = 0.42; 95% CI, 0.04-0.80).
Effect sizes are summarized in the eTable in Supplement 2.
Figure 2. Estimated Difference Between Clinician-Administered Posttraumatic Stress Disorder Scale (CAPS) and Patient-Reported Outcome Measurement
Information System (PROMIS) Depression Score at the End of Treatment and During Follow-up
A CAPS score B PROMIS depression score

10 10
Estimated difference in CAPS score (95% CI)
Estimated difference in PROMIS

depression score (95% CI)
5 5
0 0
–5 –5
–10 –10
End of treatment 3-mo Follow-up 6-mo Follow-up End of treatment 3-mo Follow-up 6-mo Follow-up
Study time point Study time point
Analyzing the difference between (A) CAPS and (B) PROMIS scores, for loving-kindness meditation (LKM) to be noninferior to cognitive processing therapy (CPT), the lower bound of
the 2-sided 95% CI for the difference in change between treatments (CPT – LKM) must be greater than the noninferiority margin (5 for CAPS, 4 for PROMIS depression) and is
indicated by the orange dotted line. Circles show the mean difference between CPT and LKM; error bars indicate 2-sided 95% CIs around the means.

The proportions with clinically meaningful improvement or loss of diagnostic status are
presented in Table 3. For CAPS-5, no differences by treatment arm were found for these parameters
in both ITT and completer samples. For PROMIS depression, greater reductions were found for
loving-kindness meditation vs CPT (for patients attending ⱖ6 visits, ⱖ4-point improvement was
noted in 24 [39.3%] veterans receiving loving-kindness meditation vs 9 [18.0%] receiving CPT;
P = .03), with no differences seen at other time points or using more stringent criteria (improvement
ⱖ8 points). Results were similar in the completer sample.
Adverse Events
Serious adverse events included 1 suicide attempt in the CPT arm and 2 deaths (due to cancer) and 1
inpatient psychiatric admission (bipolar mania) in the loving-kindness meditation arm. No serious
adverse events were deemed study related. Other adverse events included 1 disenrollment due to
risk of harm to others, 4 incidents of suicidality with intent or plan in the CPT arm, and 1 seizure in the
loving-kindness meditation arm. There were no significant differences between treatment arms in
the severity or frequency of adverse events.
The number of veterans with at least a 20-point increase in CAPS-5 PTSD score or an increase
of 2 categories in depression severity (using PROMIS scores transformed to Patient Health
Questionnaire-9 scores)34 between assessments were 3 for PTSD and 15 for depression in the CPT
group and 4 for PTSD and 7 for depression in the loving-kindness meditation group.
Discussion
This study supports the use of loving-kindness meditation as a treatment for PTSD among veterans.
Loving-kindness meditation was noninferior to CPT for PTSD and depressive symptoms at 6-month
Table 3. Improvement Over Time by Conditiona
No. (%)
Posttreatment 3-mo follow-up 6-mo follow-up
Condition CPT LKM CPT LKM CPT LKM
ITT
CAPS-5 improvement
≥10 Points 18 (19.4) 23 (25.3) 17 (18.3) 20 (22.0) 23 (24.7) 25 (27.5)
≥5 Points 27 (29.0) 33 (36.3) 31 (33.3) 36 (39.6) 35 (37.6) 38 (41.8)
Loss of DSM-5 diagnosis per CAPS-5 27 (29.0) 25 (27.5) 23 (24.7) 28 (30.8) 30 (32.3) 36 (39.6)
PTSD remission (CAPS-5 <12) 6 (6.5) 9 (9.9) 6 (6.5) 6 (6.6) 10 (10.8) 10 (11.0)
PROMIS depression T-score improvement
≥8 Points 4 (4.3) 11 (12.1) 6 (6.5) 14 (15.4) 7 (7.5) 11 (12.1)
≥4 Points 13 (14.0) 28 (30.8)b 14 (15.1) 22 (24.2) 16 (17.2) 25 (27.5)
Completers: patients attending ≥6 visits
CAPS-5 improvement
≥10 Points 15 (30.0) 19 (31.2) 15 (30.0) 16 (26.2) 16 (32.0) 19 (31.2)
≥5 Points 23 (46.0) 28 (45.9) 25 (50.0) 28 (45.9) 23 (46.0) 29 (47.5)
Loss of DSM-5 diagnosis per CAPS-5 25 (50.0) 22 (36.1) 20 (40.0) 21 (34.4) 22 (44.0) 27 (44.3)
PTSD remission (CAPS-5 <12) 5 (10.0) 7 (11.5) 6 (12.0) 4 (6.6) 8 (16.0) 8 (13.1)
PROMIS depression T-score improvement
≥8 Points 3 (6.0) 10 (16.4) 4 (8.0) 11 (18.0) 4 (8.0) 10 (16.4)
≥4 Points 9 (18.0) 24 (39.3)c 11 (22.0) 17 (27.9) 11 (22.0) 21 (34.4)
Abbreviations: CAPS-5, Clinician-Administered PTSD Scale; CPT, cognitive processing therapy; DSM-5, Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition); ITT,
intention to treat; PROMIS, Patient-Reported Outcomes Measurement Information System; PTSD, posttraumatic stress disorder.
a
Veterans with missing data coded as not improved.
b
P < .01.
c
P < .05.

follow-up, although the magnitude of improvement for both interventions was modest. Change over
time in PTSD symptoms was not found to be superior for either loving-kindness meditation or CPT
at any time point, but change over time in depressive symptoms was superior for loving-kindness
meditation compared with CPT at all time points. Those randomized to loving-kindness meditation
also attended significantly more treatment sessions, suggesting that loving-kindness meditation was
as acceptable as CPT to veterans with PTSD among our recruited sample; however, only 54% and
60% of participants attended 6 or more sessions of CPT or loving-kindness meditation, respectively.
Our results are consistent with other studies indicating that interventions without a specific
focus on trauma-related symptomatology can yield results similar to trauma-focused
interventions.15-22,46 The low completion rates for both interventions is consistent with completion
rates ranging from 39% to 68% in other PTSD studies involving veterans.47-49 In the ITT sample, the
proportions with clinically meaningful change (ⱖ5 points on CAPS-5) and no longer meeting DSM-5
criteria for PTSD at 6 months are similar to those from a review of 5 randomized clinical trials of CPT
for military-related PTSD, which found that 49% reported clinically meaningful change, and 28% to
40% no longer met criteria for PTSD.17
One explanation for the modest effects found for PTSD symptom reduction in the CPT cohort is
the group delivery format. Individually delivered CPT results in greater reductions in PTSD symptoms
than group CPT.50 Studies of active-duty military personnel undergoing group CPT found medium50
to large51 within-condition effect sizes. One trial assessed outcomes of group CPT for veterans with
PTSD and at 6-month follow-up found that 26% no longer met criteria for PTSD and a within-
condition effect size (Cohen d) of 0.76,37 consistent with our results.
Strengths and Limitations

Strengths of the study include use of a conservative noninferiority margin of 5 points for the CAPS-5,
which is narrower than the 10-point margin used by others.52 Other strengths are the study design
(which accounted for elements of interventions known to contribute to change),53 assessment of
treatment fidelity, masked clinician rating of PTSD outcomes, and 6-month follow-up.
Limitations of the study include a predominantly White male sample of veterans from 1 facility,
which limits generalizability; and high rates of noncompletion of interventions, which could bias
toward noninferiority. Statistical comparisons of secondary outcomes should be considered
exploratory given lack of adjustment for α level. In addition, there were no measures of treatment
credibility or the adequacy of masking of the assessor of PTSD symptoms.
Conclusions
In this randomized clinical trial with a sample of veterans with PTSD, group loving-kindness
meditation resulted in reductions in PTSD symptoms that were not meaningfully worse than group
CPT and higher attendance relative to CPT. For both interventions, the magnitude of PTSD symptom
reduction and rates of clinically meaningful improvement or loss of PTSD diagnostic status were
similar to outcomes reported in prior studies of veterans with PTSD. Improvement over time in
depressive symptoms was significantly greater for the loving-kindness meditation cohort relative to
CPT, although few differences were detected in rates of clinically meaningful improvement. Further
qualitative research would help to clarify the acceptability of loving-kindness meditation for PTSD.
Overall, loving-kindness meditation shows promise as a treatment for PTSD, and the findings warrant
replication.
ARTICLE INFORMATION
Accepted for Publication: March 1, 2021.
Published: April 16, 2021. doi:10.1001/jamanetworkopen.2021.6604

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Kearney DJ
et al. JAMA Network Open.
Corresponding Author: David J. Kearney, MD, VA Medical Center 111GI, 1660 S Columbian Way, Seattle, WA 98108
(david.kearney@va.gov).
Author Affiliations: VA Puget Sound Health Care System, Seattle, Washington (Kearney); Division of
Gastroenterology, Department of Medicine, University of Washington School of Medicine, Seattle (Kearney);
Center of Excellence in Substance Addiction Treatment and Education, VA Puget Sound Health Care System,
Seattle, Washington (Malte, Simpson); VA Research and Development, VA Puget Sound Health Care System,
Seattle, Washington (Storms); Department of Psychiatry and Behavioral Sciences, University of Washington
School of Medicine, Seattle (Simpson).
Author Contributions: Dr Kearney and Ms Malte had full access to all of the data in the study and take
responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Kearney, Simpson.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Kearney, Storms, Simpson.
Critical revision of the manuscript for important intellectual content: Kearney, Malte, Simpson.
Statistical analysis: Kearney, Malte.
Obtained funding: Kearney, Simpson.
Administrative, technical, or material support: Kearney, Storms.
Supervision: Kearney, Simpson.
Conflict of Interest Disclosures: None reported.
Funding/Support: This study was supported with resources from and the use of facilities at the VA Puget Sound
Health Care System. This research was supported by VA grant 1I01CX000857 (Drs Kearney and Simpson).
Role of the Funder/Sponsor: The funder was involved in the design of the trial through the peer review process
and oversaw the design and conduct of the study through appointment of a data monitoring committee; data
collection, management, and the analysis plan were also overseen by the data monitoring committee. The sponsor
did not participate in data analysis or interpretation, the preparation, review, or approval of the manuscript, or
decision to submit the manuscript for publication.
Disclaimer: The contents do not represent the views of the US Department of Veterans Affairs or the US
government.
Data Sharing Statement: See Supplement 3.
Additional Contributions: Carolyn McManus, PT, MA, and Jonas Batt, MA, LMHC, taught the loving-kindness
meditation classes and received compensation for their roles in the study. Martha Hickey, MSW, LICSW, and
Bethann Gurrad, MA, LMHC, independent therapists previously trained in cognitive processing therapy at VA
Puget Sound, provided cognitive processing therapy and received compensation for their roles in the study. Carie
Rodgers, PhD, ABPP, VA Center of Excellence for Stress and Mental Health, University of California at San Diego
School of Medicine, provided clinical supervision of cognitive processing therapy therapists and evaluation of
cognitive processing therapy treatment fidelity, for which she received no compensation. VA Puget Sound
research coordinators Kimberly Moore, BA, Ashley Morris, BA, Nicole Bernardi, MS, Larry Swanson, BA, and
Michelle Martinez, MPH, received compensation for their roles in the study. Larry Swanson also created the
research database for the study and received compensation for his role. Volunteer research assistants Kaitlin
Harding, PhD, Madeline Noland, PhD, Lisa Kothari, MA, and Margaret Reese, BA, performed fidelity coding and did
not receive compensation for their roles in the study.
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SUPPLEMENT 1.
Trial Protocol
SUPPLEMENT 2.
eAppendix. Additional Description of Loving-Kindness Meditation and Rationale for Its Use as a PTSD Treatment
eTable. Within- and Between-Condition Effect Sizes by Treatment Outcome
eFigure. Estimated Differences Between Loving-Kindness Meditation and Cognitive Processing Therapy in
Outcome Measures by Time, Patients Attending ⱖ6 Visits
eReferences
SUPPLEMENT 3.
Data Sharing Statement

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Original Investigation | Psychiatry

Loving-Kindness Meditation vs Cognitive Processing Therapy

Abstract Key Points

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TRIAL REGISTRATION Clinicaltrials.gov Identifier: NCT01962714

JAMA Network Open. 2021;4(4):e216604. doi:10.1001/jamanetworkopen.2021.6604

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Table 1. Demographic Characteristics of the Intention-to-Treat Sample

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Figure 1. Consolidated Standards of Reporting Trials (CONSORT) Flow Diagram

522 Assessed through a telephone screening interview

212 Assessed through baseline clinical evaluation

91 Assigned to LKM 93 Assigned to CPT

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CPT (Cognitive Only)

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Treatment Fidelity and Adverse Events

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Table 2. Estimated Outcome Measures by Condition and Time Pointa

Estimated mean (95% CI)

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A CAPS score B PROMIS depression score

Estimated difference in PROMIS

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Table 3. Improvement Over Time by Conditiona

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Strengths and Limitations

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