Trial Outcomes & Findings for Compassion Meditation for PTSD (NCT NCT02372396)
NCT ID: NCT02372396
Last Updated: 2018-09-05
Results Overview
Clinical interview that quantifies PTSD symptomatology according to DSM-5, generating a continuous measure of severity (range 0-80) where higher scores indicate more symptomatology
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
Baseline and 10 weeks
Results posted on
2018-09-05
Participant Flow
Participant milestones
| Measure |
CBCT-Vet
Cognitively Based Compassion Training, Veteran Version (CBCT-Vet) delivered in 10 1.5-hour group treatment sessions.
CBCT-Vet is a compassion meditation practice focused on the wish that others and the self may be free of suffering. Because this particular form of meditation has been shown to elicit positive emotion and feelings of connection with other people, it is uniquely well suited to addressing PTSD, which is characterized by strong negative affect, deficits in positive emotion and social connectedness.
|
Veteran.Calm
Veteran.calm delivered in 10 1.5-hour group treatment sessions.
Veteran.calm is a form of relaxation training that was selected as the control condition because it is a good match for nonspecific aspects of the meditative practice (e.g., attention, support, contact with a mental health provider) and it is structurally similar to meditation (e.g., restful, mind-body focus, in session and at home exercises).
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
20
|
|
Overall Study
Began Intervention
|
14
|
14
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
| Measure |
CBCT-Vet
Cognitively Based Compassion Training, Veteran Version (CBCT-Vet) delivered in 10 1.5-hour group treatment sessions.
CBCT-Vet is a compassion meditation practice focused on the wish that others and the self may be free of suffering. Because this particular form of meditation has been shown to elicit positive emotion and feelings of connection with other people, it is uniquely well suited to addressing PTSD, which is characterized by strong negative affect, deficits in positive emotion and social connectedness.
|
Veteran.Calm
Veteran.calm delivered in 10 1.5-hour group treatment sessions.
Veteran.calm is a form of relaxation training that was selected as the control condition because it is a good match for nonspecific aspects of the meditative practice (e.g., attention, support, contact with a mental health provider) and it is structurally similar to meditation (e.g., restful, mind-body focus, in session and at home exercises).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
9
|
Baseline Characteristics
Data presented on participants who began the intervention rather than on the intent-to-treat sample.
Baseline characteristics by cohort
| Measure |
CBCT-Vet
n=17 Participants
CBCT-Vet delivered in 10 1.5-hour group treatment sessions.
CBCT-Vet is a compassion meditation practice focused on the wish that others and the self may be free of suffering. Because this particular form of meditation has been shown to elicit positive emotion and feelings of connection with other people, it is uniquely well suited to addressing PTSD, which is characterized by strong negative affect, deficits in positive emotion and social connectedness.
|
Veteran.Calm
n=20 Participants
Veteran.calm delivered in 10 1.5-hour group treatment sessions.
Veteran.calm is a form of relaxation training that was selected as the control condition because it is a good match for nonspecific aspects of the meditative practice (e.g., attention, support, contact with a mental health provider) and it is structurally similar to meditation (e.g., restful, mind-body focus, in session and at home exercises).
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 16.6 • n=14 Participants • Data presented on participants who began the intervention rather than on the intent-to-treat sample.
|
52.7 years
STANDARD_DEVIATION 11.4 • n=14 Participants • Data presented on participants who began the intervention rather than on the intent-to-treat sample.
|
49.11 years
STANDARD_DEVIATION 14.5 • n=28 Participants • Data presented on participants who began the intervention rather than on the intent-to-treat sample.
|
|
Sex: Female, Male
Female
|
4 Participants
n=14 Participants • Presenting data on those who began treatment
|
3 Participants
n=14 Participants • Presenting data on those who began treatment
|
7 Participants
n=28 Participants • Presenting data on those who began treatment
|
|
Sex: Female, Male
Male
|
10 Participants
n=14 Participants • Presenting data on those who began treatment
|
11 Participants
n=14 Participants • Presenting data on those who began treatment
|
21 Participants
n=28 Participants • Presenting data on those who began treatment
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=14 Participants • Presenting data on those who initiated treatment
|
8 Participants
n=14 Participants • Presenting data on those who initiated treatment
|
10 Participants
n=28 Participants • Presenting data on those who initiated treatment
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=14 Participants • Presenting data on those who initiated treatment
|
6 Participants
n=14 Participants • Presenting data on those who initiated treatment
|
18 Participants
n=28 Participants • Presenting data on those who initiated treatment
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants • Presenting data on those who initiated treatment
|
0 Participants
n=14 Participants • Presenting data on those who initiated treatment
|
0 Participants
n=28 Participants • Presenting data on those who initiated treatment
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants • Presenting data on those who began treatment
|
0 Participants
n=14 Participants • Presenting data on those who began treatment
|
0 Participants
n=28 Participants • Presenting data on those who began treatment
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=14 Participants • Presenting data on those who began treatment
|
1 Participants
n=14 Participants • Presenting data on those who began treatment
|
2 Participants
n=28 Participants • Presenting data on those who began treatment
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=14 Participants • Presenting data on those who began treatment
|
0 Participants
n=14 Participants • Presenting data on those who began treatment
|
1 Participants
n=28 Participants • Presenting data on those who began treatment
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=14 Participants • Presenting data on those who began treatment
|
1 Participants
n=14 Participants • Presenting data on those who began treatment
|
6 Participants
n=28 Participants • Presenting data on those who began treatment
|
|
Race (NIH/OMB)
White
|
7 Participants
n=14 Participants • Presenting data on those who began treatment
|
7 Participants
n=14 Participants • Presenting data on those who began treatment
|
14 Participants
n=28 Participants • Presenting data on those who began treatment
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants • Presenting data on those who began treatment
|
5 Participants
n=14 Participants • Presenting data on those who began treatment
|
5 Participants
n=28 Participants • Presenting data on those who began treatment
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants • Presenting data on those who began treatment
|
0 Participants
n=14 Participants • Presenting data on those who began treatment
|
0 Participants
n=28 Participants • Presenting data on those who began treatment
|
|
Region of Enrollment
United States
|
17 participants
n=17 Participants
|
20 participants
n=20 Participants
|
37 participants
n=37 Participants
|
PRIMARY outcome
Timeframe: Baseline and 10 weeksPopulation: Completer analysis
Clinical interview that quantifies PTSD symptomatology according to DSM-5, generating a continuous measure of severity (range 0-80) where higher scores indicate more symptomatology
Outcome measures
| Measure |
CBCT-Vet
n=10 Participants
CBCT-Vet delivered in 10 1.5-hour group treatment sessions.
CBCT-Vet is a compassion meditation practice focused on the wish that others and the self may be free of suffering. Because this particular form of meditation has been shown to elicit positive emotion and feelings of connection with other people, it is uniquely well suited to addressing PTSD, which is characterized by strong negative affect, deficits in positive emotion and social connectedness.
|
Veteran.Calm
n=11 Participants
Veteran.calm delivered in 10 1.5-hour group treatment sessions.
Veteran.calm is a form of relaxation training that was selected as the control condition because it is a good match for nonspecific aspects of the meditative practice (e.g., attention, support, contact with a mental health provider) and it is structurally similar to meditation (e.g., restful, mind-body focus, in session and at home exercises).
|
|---|---|---|
|
Clinician Administered PTSD Scale -5 (CAPS-5) PTSD Severity
Baseline
|
35.8 units on a scale
Standard Deviation 13.9
|
37.9 units on a scale
Standard Deviation 11.9
|
|
Clinician Administered PTSD Scale -5 (CAPS-5) PTSD Severity
10 weeks
|
20.4 units on a scale
Standard Deviation 11.8
|
35.3 units on a scale
Standard Deviation 7.7
|
Adverse Events
CBCT-Vet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Veteran.Calm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place