Trial Outcomes & Findings for Meditation Interventions for Treatment of PTSD in Veterans (NCT NCT01548742)
NCT ID: NCT01548742
Last Updated: 2015-12-10
Results Overview
The PCL is a valid and reliable measure of PTSD symptoms. Score range from 17-85; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 10 or more points on the PCL.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
116 participants
Primary outcome timeframe
Baseline, Weeks 3, 6, 9 and 17
Results posted on
2015-12-10
Participant Flow
Participants were recruited through flyers posted in targeted clinics and clinical referrals at the Minneapolis VA Medical Center.
Participants completed a 5-hour eligibility and baseline assessment that included a structured clinical interview and self-report measures. Randomization occurred for those meeting study inclusion criteria.
Participant milestones
| Measure |
Arm 1: Mindfulness-Based Stress Reduction (MBSR)
Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
|
Arm 2: Present-Centered Group Therapy (PCGT)
Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
58
|
|
Overall Study
COMPLETED
|
45
|
54
|
|
Overall Study
NOT COMPLETED
|
13
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Meditation Interventions for Treatment of PTSD in Veterans
Baseline characteristics by cohort
| Measure |
Arm 1: Mindfulness-Based Stress Reduction (MBSR)
n=58 Participants
Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
|
Arm 2: Present-Centered Group Therapy (PCGT)
n=58 Participants
Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
58.5 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
47 participants
n=5 Participants
|
50 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
6 participants
n=5 Participants
|
0 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Service Era
OEF/OIF
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Service Era
Gulf War
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Service Era
Vietnam War
|
41 participants
n=5 Participants
|
45 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
Service Era
Other
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Lifetime trauma exposure
|
7.9 No. of events
STANDARD_DEVIATION 3.3 • n=5 Participants
|
7.5 No. of events
STANDARD_DEVIATION 3.0 • n=7 Participants
|
7.7 No. of events
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Lifetime trauma exposure event type
Combat exposure
|
39 participants
n=5 Participants
|
47 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
Lifetime trauma exposure event type
Sexual trauma
|
21 participants
n=5 Participants
|
11 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Lifetime trauma exposure event type
Physical assault
|
39 participants
n=5 Participants
|
37 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Lifetime trauma exposure event type
Disaster exposure
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Lifetime trauma exposure event type
Serious accident
|
38 participants
n=5 Participants
|
36 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
Lifetime trauma exposure event type
Life-threatening illness or injury
|
34 participants
n=5 Participants
|
33 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Lifetime trauma exposure event type
Other traumatic event
|
55 participants
n=5 Participants
|
55 participants
n=7 Participants
|
110 participants
n=5 Participants
|
|
PTSD diagnosis
Full PTSD criteria
|
57 participants
n=5 Participants
|
56 participants
n=7 Participants
|
113 participants
n=5 Participants
|
|
PTSD diagnosis
Subthreshold PTSD
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Comorbid mood disorder
|
26 participants
n=5 Participants
|
23 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Taking psychotropic medication
|
51 participants
n=5 Participants
|
49 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Total number of psychotherapy mental health visits
|
13.2 sessions
STANDARD_DEVIATION 28.3 • n=5 Participants
|
14.6 sessions
STANDARD_DEVIATION 29.2 • n=7 Participants
|
13.9 sessions
STANDARD_DEVIATION 28.7 • n=5 Participants
|
|
Duration of previous mental health care
|
69.0 months
STANDARD_DEVIATION 53.3 • n=5 Participants
|
63.9 months
STANDARD_DEVIATION 45.2 • n=7 Participants
|
66.5 months
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Number of participants receiving 8 or more therapy sessions in PTSD or mental health clinics
|
19 participants
n=5 Participants
|
24 participants
n=7 Participants
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 3, 6, 9 and 17Population: Intent to treat population (all participants randomized to treatment).
The PCL is a valid and reliable measure of PTSD symptoms. Score range from 17-85; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 10 or more points on the PCL.
Outcome measures
| Measure |
Arm 1: Mindfulness-Based Stress Reduction (MBSR)
n=58 Participants
Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
|
Arm 2: Present-Centered Group Therapy (PCGT)
n=58 Participants
Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
|
|---|---|---|
|
PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up
Baseline PCL
|
63.6 units on a scale
Interval 60.6 to 66.7
|
58.8 units on a scale
Interval 55.7 to 61.8
|
|
PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up
Week 3 PCL
|
63.9 units on a scale
Interval 60.8 to 67.0
|
61.7 units on a scale
Interval 58.6 to 64.8
|
|
PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up
Wee 6 PCL
|
61.3 units on a scale
Interval 58.1 to 64.4
|
60.7 units on a scale
Interval 57.6 to 63.8
|
|
PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up
Week 9 PCL
|
55.7 units on a scale
Interval 52.6 to 58.9
|
55.8 units on a scale
Interval 52.7 to 58.9
|
|
PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up
Week 17 PCL
|
54.4 units on a scale
Interval 51.2 to 57.6
|
56.0 units on a scale
Interval 52.9 to 59.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 9 and 17Population: Intent to treat population (all participants randomized to treatment).
The CAPS is a valid and reliable measure of PTSD symptom severity. Score range from 0-136; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 10 or more points on the CAPS.
Outcome measures
| Measure |
Arm 1: Mindfulness-Based Stress Reduction (MBSR)
n=58 Participants
Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
|
Arm 2: Present-Centered Group Therapy (PCGT)
n=58 Participants
Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
|
|---|---|---|
|
PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up
Baseline CAPS
|
69.9 units on a scale
Interval 65.0 to 74.8
|
62.5 units on a scale
Interval 57.6 to 67.4
|
|
PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up
Week 9 CAPS
|
56.3 units on a scale
Interval 51.0 to 61.5
|
51.7 units on a scale
Interval 46.5 to 56.8
|
|
PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up
Week 17 CAPS
|
49.8 units on a scale
Interval 44.3 to 55.3
|
50.6 units on a scale
Interval 45.4 to 55.8
|
SECONDARY outcome
Timeframe: Baseline, Weeks 9 and 17Population: Intent to treat population (all participants randomized to treatment).
The PHQ-9 is a valid and reliable measure of depression symptom severity. Score range from 0-27; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 5 or more points on the PHQ-9.
Outcome measures
| Measure |
Arm 1: Mindfulness-Based Stress Reduction (MBSR)
n=58 Participants
Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
|
Arm 2: Present-Centered Group Therapy (PCGT)
n=58 Participants
Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
|
|---|---|---|
|
Depression Symptom Severity on the Patient Health Questionnaire-9 (PHQ-9) at Baseline, After Treatment, and at 2-Month Follow-up
Baseline PHQ-9
|
15.5 units on a scale
Interval 13.9 to 17.0
|
14.6 units on a scale
Interval 13.1 to 16.2
|
|
Depression Symptom Severity on the Patient Health Questionnaire-9 (PHQ-9) at Baseline, After Treatment, and at 2-Month Follow-up
Week 9 PHQ-9
|
13.6 units on a scale
Interval 12.0 to 15.1
|
13.9 units on a scale
Interval 12.3 to 15.4
|
|
Depression Symptom Severity on the Patient Health Questionnaire-9 (PHQ-9) at Baseline, After Treatment, and at 2-Month Follow-up
Week 17 PHQ-9
|
13.3 units on a scale
Interval 11.7 to 15.0
|
13.8 units on a scale
Interval 12.2 to 15.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 9 and 17Population: Intent to treat analysis
% of participants with clinically significant improvement in self-reported PTSD symptoms defined as a reduction of 10 points or more on the PCL.
Outcome measures
| Measure |
Arm 1: Mindfulness-Based Stress Reduction (MBSR)
n=58 Participants
Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
|
Arm 2: Present-Centered Group Therapy (PCGT)
n=58 Participants
Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
|
|---|---|---|
|
Clinically Significant Improvement in Self-reported PTSD Symptoms as Measured by the PCL
% responders, Week 9
|
36.5 percentage clinical responders
Interval 24.0 to 49.0
|
22.8 percentage clinical responders
Interval 10.9 to 34.7
|
|
Clinically Significant Improvement in Self-reported PTSD Symptoms as Measured by the PCL
% responders, Week 17
|
48.9 percentage clinical responders
Interval 35.1 to 62.8
|
28.1 percentage clinical responders
Interval 15.5 to 40.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 9 and 17Population: Intent to treat analysis
% of participants with clinically significant improvement in interviewer-rated PTSD symptom severity defined as a reduction of 10 points or more on the CAPS.
Outcome measures
| Measure |
Arm 1: Mindfulness-Based Stress Reduction (MBSR)
n=58 Participants
Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
|
Arm 2: Present-Centered Group Therapy (PCGT)
n=58 Participants
Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
|
|---|---|---|
|
Clinically Significant Improvement in Clinician Administered PTSD Scale (CAPS)
% responders, Week 9
|
63.5 percentage clinical responders
Interval 49.8 to 77.1
|
49.1 percentage clinical responders
Interval 36.1 to 62.1
|
|
Clinically Significant Improvement in Clinician Administered PTSD Scale (CAPS)
% responders, Week 17
|
66.7 percentage clinical responders
Interval 52.1 to 81.2
|
54.5 percentage clinical responders
Interval 41.4 to 67.7
|
Adverse Events
Arm 1: Mindfulness-Based Stress Reduction (MBSR)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Present-Centered Group Therapy (PCGT)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Mindfulness-Based Stress Reduction (MBSR)
n=58 participants at risk
Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
|
Arm 2: Present-Centered Group Therapy (PCGT)
n=58 participants at risk
Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
|
|---|---|---|
|
Psychiatric disorders
Suicide Attempt or worsening of symptoms
|
1.7%
1/58 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
General disorders
Crushed by falling tree
|
0.00%
0/58
|
1.7%
1/58 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Kelvin O. Lim, MD (Principal Investigator)
Minneapolis VA Medical Center
Phone: 612-467-3323
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place