Trial Outcomes & Findings for Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD) (NCT NCT03874793)
NCT ID: NCT03874793
Last Updated: 2026-03-20
Results Overview
Posterior cingulate-seed functional connectivity with dorsolateral PFC index (PCC seed-dlPFC rsFC index) was measured using fMRI \[BOLD\] signal, a measure of brain regional blood flow used as a proxy for neural activity. BOLD signal while "resting" identified regions whose activity is correlated with a "seed" ROI within PCC. A whole-brain map of Pearson's (r) was transformed (Fisher r-to-Z) to a T-map. A beta from cluster in the hypothesized dlPFC region was extracted (as the "PCC seed-dlPFC rsFC index"). Fisher r-to-Z scores are not bounded to the -1 to +1 range, although practically rsFC scores fall in the -1.5 to +1.5 range. This index was used to test a pre-registered mechanistic hypothesis that MBCT would lead to an increase in PCC-dlPFC rsFC index, associated with increase in meta-cognitive emotional regulation. Increase in PCC-dlPFC rsFC index might theoretically be better; but this has not been clinically validated, and no clinically relevant thresholds for this index.
COMPLETED
NA
61 participants
Intake (pre-therapy) and post therapy (approximately 9 - 10 weeks)
2026-03-20
Participant Flow
Participant milestones
| Measure |
Mindfulness-Based Cognitive Therapy
Participants will have 8 weeks of group therapy and will be asked to do MBCT exercises for approximately 20-30 minutes on 5 or more days/week.
|
Muscle Relaxation Therapy (MRG)
Participants will have 8 weeks of group therapy participants and will be asked to do MRG exercises for approximately 20-30 minutes on 5 or more days/week.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
|
Overall Study
COMPLETED
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
| Measure |
Mindfulness-Based Cognitive Therapy
Participants will have 8 weeks of group therapy and will be asked to do MBCT exercises for approximately 20-30 minutes on 5 or more days/week.
|
Muscle Relaxation Therapy (MRG)
Participants will have 8 weeks of group therapy participants and will be asked to do MRG exercises for approximately 20-30 minutes on 5 or more days/week.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
Baseline Characteristics
Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
Mindfulness-Based Cognitive Therapy
n=31 Participants
Participants will have 8 weeks of group therapy and will be asked to do MBCT exercises for approximately 20-30 minutes on 5 or more days/week.
|
Muscle Relaxation Therapy (MRG)
n=30 Participants
Participants will have 8 weeks of group therapy participants and will be asked to do MRG exercises for approximately 20-30 minutes on 5 or more days/week.
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=61 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=31 Participants
|
30 Participants
n=30 Participants
|
61 Participants
n=61 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=61 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=31 Participants
|
27 Participants
n=30 Participants
|
54 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
7 Participants
n=61 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=61 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=31 Participants
|
28 Participants
n=30 Participants
|
55 Participants
n=61 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=61 Participants
|
|
Resting-state functional connectivity btw posterior cingulate cortex (PCC) and dorsolateral PFC
|
0.0010 arbitrary (beta)
STANDARD_DEVIATION 0.0927 • n=31 Participants
|
0.0279 arbitrary (beta)
STANDARD_DEVIATION 0.0458 • n=30 Participants
|
0.0141 arbitrary (beta)
STANDARD_DEVIATION .0740 • n=61 Participants
|
PRIMARY outcome
Timeframe: Intake (pre-therapy) and post therapy (approximately 9 - 10 weeks)Posterior cingulate-seed functional connectivity with dorsolateral PFC index (PCC seed-dlPFC rsFC index) was measured using fMRI \[BOLD\] signal, a measure of brain regional blood flow used as a proxy for neural activity. BOLD signal while "resting" identified regions whose activity is correlated with a "seed" ROI within PCC. A whole-brain map of Pearson's (r) was transformed (Fisher r-to-Z) to a T-map. A beta from cluster in the hypothesized dlPFC region was extracted (as the "PCC seed-dlPFC rsFC index"). Fisher r-to-Z scores are not bounded to the -1 to +1 range, although practically rsFC scores fall in the -1.5 to +1.5 range. This index was used to test a pre-registered mechanistic hypothesis that MBCT would lead to an increase in PCC-dlPFC rsFC index, associated with increase in meta-cognitive emotional regulation. Increase in PCC-dlPFC rsFC index might theoretically be better; but this has not been clinically validated, and no clinically relevant thresholds for this index.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy
n=21 Participants
Participants will have 8 weeks of group therapy and will be asked to do MBCT exercises for approximately 20-30 minutes on 5 or more days/week.
|
Muscle Relaxation Therapy (MRG)
n=20 Participants
Participants will have 8 weeks of group therapy participants and will be asked to do MRG exercises for approximately 20-30 minutes on 5 or more days/week.
|
|---|---|---|
|
Change (From Intake to Post-therapy) in Resting-state Functional Connectivity Between Posterior Cingulate Cortex (PCC) and Dorsolateral Prefrontal Cortex (dlPFC)
|
0.0417 rsFC Beta change score intake to post
Standard Error 0.0169
|
-0.0262 rsFC Beta change score intake to post
Standard Error 0.0142
|
SECONDARY outcome
Timeframe: pre-therapy and post therapy (approximately 9-10 weeks)Population: We analyzed all subjects who had both a usable intake rsfMRI scan and a usable post-therapy rsfMRI scan (N=41)
Posterior cingulate-seed functional connectivity with insula index (PCC seed-insula rsFC index) was measured using fMRI \[BOLD\] signal, a measure of brain regional blood flow used as a proxy for neural activity. BOLD signal while "resting" identified regions whose activity is correlated with a "seed" ROI within PCC. A whole-brain map of Pearson's (r) was transformed (Fisher r-to-Z) to a T-map. A beta from a cluster in the hypothesized insula region was extracted (as the "PCC seed-insula rsFC index"). Fisher r-to-Z scores are not bounded to the -1 to +1 range, although practically rsFC scores fall in the -1.5 to +1.5 range. This index was used to test a pre-registered mechanistic hypothesis that MBCT would lead to decrease in PCC-insula rsFC index (more negative), associated with decreased PTSD hyperarousal symptoms. Decrease in PCC-insula rsFC index might theoretically be better; but this has not been clinically validated, and there are no clinically relevant thresholds for this index.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy
n=21 Participants
Participants will have 8 weeks of group therapy and will be asked to do MBCT exercises for approximately 20-30 minutes on 5 or more days/week.
|
Muscle Relaxation Therapy (MRG)
n=20 Participants
Participants will have 8 weeks of group therapy participants and will be asked to do MRG exercises for approximately 20-30 minutes on 5 or more days/week.
|
|---|---|---|
|
Change (From Intake to Post-therapy) in Resting-state Functional Connectivity (rsFC) Between Posterior Cingulate Cortex (PCC) and Insula Cortex (Insula)
Left Insula rsFC (PCC seed) change intake to post
|
-0.0067 Beta of BOLD rsFC change score
Standard Error 0.0090
|
-0.0240 Beta of BOLD rsFC change score
Standard Error 0.0103
|
|
Change (From Intake to Post-therapy) in Resting-state Functional Connectivity (rsFC) Between Posterior Cingulate Cortex (PCC) and Insula Cortex (Insula)
Right Insula rsFC (PCC seed) change intake to post
|
-0.0031 Beta of BOLD rsFC change score
Standard Error 0.0108
|
-0.0223 Beta of BOLD rsFC change score
Standard Error 0.0112
|
Adverse Events
Mindfulness-Based Cognitive Therapy
Muscle Relaxation Therapy (MRG)
Serious adverse events
| Measure |
Mindfulness-Based Cognitive Therapy
n=31 participants at risk
Participants will have 8 weeks of group therapy and will be asked to do MBCT exercises for approximately 20-30 minutes on 5 or more days/week.
Mindfulness-Based Cognitive Therapy: Participants will attend 8 weekly group therapy sessions. Prior to and after therapy participants will have assessments related to their PTSD, fill out surveys, and have an fMRI.
|
Muscle Relaxation Therapy (MRG)
n=30 participants at risk
Participants will have 8 weeks of group therapy participants and will be asked to do MRG exercises for approximately 20-30 minutes on 5 or more days/week.
Muscle Relaxation Therapy: Participants will attend 8 weekly group therapy sessions. Prior to and after therapy participants will have assessments related to their PTSD, fill out surveys, and have an fMRI.
|
|---|---|---|
|
Psychiatric disorders
Hospitalization
|
3.2%
1/31 • Number of events 1 • 2 years and 6 months
|
3.3%
1/30 • Number of events 1 • 2 years and 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place