Trial Outcomes & Findings for Loving-Kindness Meditation for PTSD (NCT NCT01962714)
NCT ID: NCT01962714
Last Updated: 2020-03-17
Results Overview
PTSD diagnostic severity was measured using the 30-item CAPS-5 structured interview (range 0-80; higher scores indicate worse PTSD). Linear mixed effects models (LMM) were used to analyze continuous outcomes, with time and time by treatment interaction included as fixed effects to determine if differences exist between conditions by time. Non-inferiority of LKM to CPT-C was claimed if the lower limit of the 95% confidence interval for difference in change rate from baseline to 6-month follow-up in mean CAPS or depression score was greater than (i.e., did not extend beyond) negative delta (defined as 5 points on the CAPS-5 measure). A 2-sided 95% confidence interval of the difference in change rate from baseline to 6-month follow-up between groups (CPT-C minus LKM) was calculated, with a positive value indicating a greater reduction in scores from baseline for LKM compared to CPT-C.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
184 participants
Primary outcome timeframe
6 months post-intervention
Results posted on
2020-03-17
Participant Flow
Participant milestones
| Measure |
Loving-Kindness Meditation
A 12-week duration, 90-minute per session Loving-Kindness Meditation (LKM) course, taught in groups of 10 participants.
Loving-Kindness Meditation: 12-week loving-kindness meditation course
|
Cognitive Processing Therapy - Cognitive Only
A 12-week duration, 90-minute per session Cognitive Processing Therapy (CPT) course, taught in groups of 10 participants.
Cognitive Processing Therapy: 12-week CPT course
|
|---|---|---|
|
Overall Study
STARTED
|
91
|
93
|
|
Overall Study
Immediate Post-treatment Assessment
|
63
|
57
|
|
Overall Study
3-month Follow-up
|
58
|
56
|
|
Overall Study
COMPLETED
|
61
|
60
|
|
Overall Study
NOT COMPLETED
|
30
|
33
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Loving-Kindness Meditation for PTSD
Baseline characteristics by cohort
| Measure |
Loving-Kindness Meditation
n=91 Participants
The intervention consisted of 12 weekly 90-minute group sessions. In Loving-Kindness Meditation, a person sits and calls to mind a particular person (e.g., a good friend) and silently repeats phrases that invoke goodwill for that person, e.g., the desire for safety, happiness, health, and peace. Over 12 weeks, the practice expands to bring to mind other individuals or categories of people, including themselves, neutral persons, and those who have caused difficulty or harm, changing the phrases as needed. Participants are asked to notice any thoughts and feelings elicited by the phrases with an attitude of kindness, curiosity, and non-judgment, regardless of content. Each session begins with either mindfulness meditation (weeks 1 \& 2) or LKM meditation (weeks 3 through 12) followed by group discussion and additional LKM teaching and practice. Homework for LKM consisted of 30 minutes of meditation 6 days per week using compact disks (CDs) as well as informal LKM practice in daily life.
|
Cognitive Processing Therapy - Cognitive Only
n=93 Participants
CPT-C does not include writing a trauma narrative. The intervention is based on Resick and colleagues' manual for treating PTSD among military veterans, which combines cognitive restructuring with emotional processing of trauma- related content. Sessions initially focus on rigid or inaccurate beliefs about the traumatic event itself, which often reflect self-blame or hindsight bias. Later sessions address over-generalized beliefs about self and others that result from a traumatic event relevant to five key areas: safety, trust, power, esteem, and intimacy. Clients learn to identify and modify their beliefs to develop more balanced, flexible, and ultimately, more adaptive beliefs. Homework for CPT-C consisted of 30 minutes of homework 6 days a week, including writing an impact statement at the beginning and the end of treatment and completing worksheets and exercises regarding safety, trust, power/control, esteem, and intimacy.
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
57.1 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
77 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Transgender
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
88 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
91 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual (DSM)-5 (CAPS-5)
|
35.54 units on a scale
STANDARD_DEVIATION 12.12 • n=5 Participants
|
35.53 units on a scale
STANDARD_DEVIATION 11.48 • n=7 Participants
|
35.53 units on a scale
STANDARD_DEVIATION 11.77 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post-interventionPTSD diagnostic severity was measured using the 30-item CAPS-5 structured interview (range 0-80; higher scores indicate worse PTSD). Linear mixed effects models (LMM) were used to analyze continuous outcomes, with time and time by treatment interaction included as fixed effects to determine if differences exist between conditions by time. Non-inferiority of LKM to CPT-C was claimed if the lower limit of the 95% confidence interval for difference in change rate from baseline to 6-month follow-up in mean CAPS or depression score was greater than (i.e., did not extend beyond) negative delta (defined as 5 points on the CAPS-5 measure). A 2-sided 95% confidence interval of the difference in change rate from baseline to 6-month follow-up between groups (CPT-C minus LKM) was calculated, with a positive value indicating a greater reduction in scores from baseline for LKM compared to CPT-C.
Outcome measures
| Measure |
Loving-Kindness Meditation
n=91 Participants
A 12-week duration, 90-minute per session Loving-Kindness Meditation (LKM) course, taught in groups of 10 participants.
Loving-Kindness Meditation: 12-week loving-kindness meditation course
|
Cognitive Processing Therapy - Cognitive Only
n=93 Participants
A 12-week duration, 90-minute per session Cognitive Processing Therapy (CPT) course, taught in groups of 10 participants.
Cognitive Processing Therapy: 12-week CPT course
|
|---|---|---|
|
Clinician Administered PTSD Scale (CAPS-5) Score
|
25.92 units on a scale
Interval 22.62 to 29.23
|
28.02 units on a scale
Interval 24.72 to 31.32
|
PRIMARY outcome
Timeframe: 6 months post-interventionDepression was assessed using the National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) depression measure. This scale utilizes item-response theory and is scored using a T-score metric with a mean of 50 and SD=10 in the US general population. Higher scores indicate more severe depression.
Outcome measures
| Measure |
Loving-Kindness Meditation
n=91 Participants
A 12-week duration, 90-minute per session Loving-Kindness Meditation (LKM) course, taught in groups of 10 participants.
Loving-Kindness Meditation: 12-week loving-kindness meditation course
|
Cognitive Processing Therapy - Cognitive Only
n=93 Participants
A 12-week duration, 90-minute per session Cognitive Processing Therapy (CPT) course, taught in groups of 10 participants.
Cognitive Processing Therapy: 12-week CPT course
|
|---|---|---|
|
NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score
|
58.88 units on a scale
Interval 56.86 to 60.91
|
61.22 units on a scale
Interval 59.21 to 68.23
|
Adverse Events
Loving-Kindness Meditation
Serious events: 5 serious events
Other events: 11 other events
Deaths: 2 deaths
Cognitive Processing Therapy - Cognitive Only
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Loving-Kindness Meditation
n=91 participants at risk
A 12-week duration, 90-minute per session Loving-Kindness Meditation (LKM) course, taught in groups of 10 participants.
|
Cognitive Processing Therapy - Cognitive Only
n=93 participants at risk
A 12-week duration, 90-minute per session Cognitive Processing Therapy (CPT) course, taught in groups of 10 participants.
|
|---|---|---|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/91 • From baseline to 6-month follow-up (approximately 9 months total).
We prospectively monitored hospitalizations, suicidality and death. In addition we recorded events according to the following criteria: An increase of 20 or more points on the total CAPS-5 score since the last assessment point or an increase in depression severity of 2 or more severity categories using a rubric that transformed PROMIS depression values scores to Patient Health Questionnaire (PHQ)-9 scores and categories
|
1.1%
1/93 • Number of events 1 • From baseline to 6-month follow-up (approximately 9 months total).
We prospectively monitored hospitalizations, suicidality and death. In addition we recorded events according to the following criteria: An increase of 20 or more points on the total CAPS-5 score since the last assessment point or an increase in depression severity of 2 or more severity categories using a rubric that transformed PROMIS depression values scores to Patient Health Questionnaire (PHQ)-9 scores and categories
|
|
Psychiatric disorders
Inpatient psychiatric admission
|
1.1%
1/91 • Number of events 1 • From baseline to 6-month follow-up (approximately 9 months total).
We prospectively monitored hospitalizations, suicidality and death. In addition we recorded events according to the following criteria: An increase of 20 or more points on the total CAPS-5 score since the last assessment point or an increase in depression severity of 2 or more severity categories using a rubric that transformed PROMIS depression values scores to Patient Health Questionnaire (PHQ)-9 scores and categories
|
0.00%
0/93 • From baseline to 6-month follow-up (approximately 9 months total).
We prospectively monitored hospitalizations, suicidality and death. In addition we recorded events according to the following criteria: An increase of 20 or more points on the total CAPS-5 score since the last assessment point or an increase in depression severity of 2 or more severity categories using a rubric that transformed PROMIS depression values scores to Patient Health Questionnaire (PHQ)-9 scores and categories
|
|
Psychiatric disorders
Risk of Harm to Others
|
0.00%
0/91 • From baseline to 6-month follow-up (approximately 9 months total).
We prospectively monitored hospitalizations, suicidality and death. In addition we recorded events according to the following criteria: An increase of 20 or more points on the total CAPS-5 score since the last assessment point or an increase in depression severity of 2 or more severity categories using a rubric that transformed PROMIS depression values scores to Patient Health Questionnaire (PHQ)-9 scores and categories
|
1.1%
1/93 • Number of events 1 • From baseline to 6-month follow-up (approximately 9 months total).
We prospectively monitored hospitalizations, suicidality and death. In addition we recorded events according to the following criteria: An increase of 20 or more points on the total CAPS-5 score since the last assessment point or an increase in depression severity of 2 or more severity categories using a rubric that transformed PROMIS depression values scores to Patient Health Questionnaire (PHQ)-9 scores and categories
|
|
Psychiatric disorders
Suicidality with Intent or Plan requiring staff intervention
|
4.4%
4/91 • Number of events 4 • From baseline to 6-month follow-up (approximately 9 months total).
We prospectively monitored hospitalizations, suicidality and death. In addition we recorded events according to the following criteria: An increase of 20 or more points on the total CAPS-5 score since the last assessment point or an increase in depression severity of 2 or more severity categories using a rubric that transformed PROMIS depression values scores to Patient Health Questionnaire (PHQ)-9 scores and categories
|
0.00%
0/93 • From baseline to 6-month follow-up (approximately 9 months total).
We prospectively monitored hospitalizations, suicidality and death. In addition we recorded events according to the following criteria: An increase of 20 or more points on the total CAPS-5 score since the last assessment point or an increase in depression severity of 2 or more severity categories using a rubric that transformed PROMIS depression values scores to Patient Health Questionnaire (PHQ)-9 scores and categories
|
|
Nervous system disorders
Seizure
|
0.00%
0/91 • From baseline to 6-month follow-up (approximately 9 months total).
We prospectively monitored hospitalizations, suicidality and death. In addition we recorded events according to the following criteria: An increase of 20 or more points on the total CAPS-5 score since the last assessment point or an increase in depression severity of 2 or more severity categories using a rubric that transformed PROMIS depression values scores to Patient Health Questionnaire (PHQ)-9 scores and categories
|
1.1%
1/93 • Number of events 1 • From baseline to 6-month follow-up (approximately 9 months total).
We prospectively monitored hospitalizations, suicidality and death. In addition we recorded events according to the following criteria: An increase of 20 or more points on the total CAPS-5 score since the last assessment point or an increase in depression severity of 2 or more severity categories using a rubric that transformed PROMIS depression values scores to Patient Health Questionnaire (PHQ)-9 scores and categories
|
Other adverse events
| Measure |
Loving-Kindness Meditation
n=91 participants at risk
A 12-week duration, 90-minute per session Loving-Kindness Meditation (LKM) course, taught in groups of 10 participants.
|
Cognitive Processing Therapy - Cognitive Only
n=93 participants at risk
A 12-week duration, 90-minute per session Cognitive Processing Therapy (CPT) course, taught in groups of 10 participants.
|
|---|---|---|
|
Psychiatric disorders
Increase in depression score
|
7.7%
7/91 • Number of events 91 • From baseline to 6-month follow-up (approximately 9 months total).
We prospectively monitored hospitalizations, suicidality and death. In addition we recorded events according to the following criteria: An increase of 20 or more points on the total CAPS-5 score since the last assessment point or an increase in depression severity of 2 or more severity categories using a rubric that transformed PROMIS depression values scores to Patient Health Questionnaire (PHQ)-9 scores and categories
|
15.1%
14/93 • Number of events 93 • From baseline to 6-month follow-up (approximately 9 months total).
We prospectively monitored hospitalizations, suicidality and death. In addition we recorded events according to the following criteria: An increase of 20 or more points on the total CAPS-5 score since the last assessment point or an increase in depression severity of 2 or more severity categories using a rubric that transformed PROMIS depression values scores to Patient Health Questionnaire (PHQ)-9 scores and categories
|
|
Psychiatric disorders
Increase in PTSD severity score
|
4.4%
4/91 • Number of events 91 • From baseline to 6-month follow-up (approximately 9 months total).
We prospectively monitored hospitalizations, suicidality and death. In addition we recorded events according to the following criteria: An increase of 20 or more points on the total CAPS-5 score since the last assessment point or an increase in depression severity of 2 or more severity categories using a rubric that transformed PROMIS depression values scores to Patient Health Questionnaire (PHQ)-9 scores and categories
|
3.2%
3/93 • Number of events 93 • From baseline to 6-month follow-up (approximately 9 months total).
We prospectively monitored hospitalizations, suicidality and death. In addition we recorded events according to the following criteria: An increase of 20 or more points on the total CAPS-5 score since the last assessment point or an increase in depression severity of 2 or more severity categories using a rubric that transformed PROMIS depression values scores to Patient Health Questionnaire (PHQ)-9 scores and categories
|
|
Psychiatric disorders
Risk of harm to others
|
0.00%
0/91 • From baseline to 6-month follow-up (approximately 9 months total).
We prospectively monitored hospitalizations, suicidality and death. In addition we recorded events according to the following criteria: An increase of 20 or more points on the total CAPS-5 score since the last assessment point or an increase in depression severity of 2 or more severity categories using a rubric that transformed PROMIS depression values scores to Patient Health Questionnaire (PHQ)-9 scores and categories
|
1.1%
1/93 • Number of events 93 • From baseline to 6-month follow-up (approximately 9 months total).
We prospectively monitored hospitalizations, suicidality and death. In addition we recorded events according to the following criteria: An increase of 20 or more points on the total CAPS-5 score since the last assessment point or an increase in depression severity of 2 or more severity categories using a rubric that transformed PROMIS depression values scores to Patient Health Questionnaire (PHQ)-9 scores and categories
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place