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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61AT009867-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| University of Michigan | OTHER |
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This study will examine the effects of psychotherapy as treatment for PTSD, and specifically how brain activity and brain connectivity is affected by Mindfulness Based Cognitive Therapy (MBCT) and an active mind-body comparison comparison therapy.
This research will see how brain activity and brain connectivity is affected by Mindfulness Based Cognitive Therapy (MBCT) and an active comparison therapy called Muscle Relaxation Therapy (MRT). Participants that qualify to be in this study will be randomly assigned to receive 8 weeks of group therapy in either MBCT or MRT treatments. Prior to receiving therapy participants will: complete baseline assessments related to their PTSD; fill out surveys; have an functional magnetic resonance imaging (fMRI); and provide saliva samples. These assessments will be repeated after the therapy is over. Overall study participation should last approximately 10-12 weeks.
Due to COVID precautions, treatments shifted from in-person to remotely-delivered ("Zoom" video-conferencing) modality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Cognitive Therapy | Experimental | 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) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Cognitive Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change (From Intake to Post-therapy) in Resting-state Functional Connectivity Between Posterior Cingulate Cortex (PCC) and Dorsolateral Prefrontal Cortex (dlPFC) | 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. | Intake (pre-therapy) and post therapy (approximately 9 - 10 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change (From Intake to Post-therapy) in Resting-state Functional Connectivity (rsFC) Between Posterior Cingulate Cortex (PCC) and Insula Cortex (Insula) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony King, Ph.D. | Ohio State University | Principal Investigator |
| David Fresco, Ph.D | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States | ||
| Ohio State University |
We plan to make available data from fMRI scans from human subjects initially to collaborators for independent replication / data pooling. We also plan to make the de-identified brain scans available to the broad scientific community, however, additional redaction steps may need to be made to brain scans to ensure subject confidentiality / inability to identify individuals from brain scans. Completely de-identified research data (redacted according to NIH practice to prevent disclosure of personal identifiers) which documents the research findings will be made available after the main findings from the finalized research dataset have been accepted for publication.
Within 36 months of completion of the project.
Access to data generated by the project will be available for educational, research and non-profit purposes to researchers who provide a methodologically sound proposal. Data generated under this project will be administered in accordance with NIH Sharing policies, including NIH Policy on Dissemination of NIH-Funded Clinical Trial Information (8/2016), and the NIH Grants Policy Statement (Availability of Research Results) (11/2015). Depending on such NIH policies, Data generated by this project may be available for educational, research or non-commercial purposes under the terms of a data use agreement. Data will be stored in an established data repository (e.g. Inter-university Consortium for Political and Social Research (ICPSR): icpsr.umich.edu) with appropriate provisions for curation and longterm preservation.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Muscle Relaxation Therapy (MRG) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change (From Intake to Post-therapy) in Resting-state Functional Connectivity Between Posterior Cingulate Cortex (PCC) and Dorsolateral Prefrontal Cortex (dlPFC) | 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. | Posted | Mean | Standard Error | rsFC Beta change score intake to post | Intake (pre-therapy) and post therapy (approximately 9 - 10 weeks) |
2 years and 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment | Participant voluntarily self-admitted |
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The COVID-19 pandemic led to participants lost to follow-up / unable to receive post-treatment scans. Interventiions were shifted to remotely delivered (Zoom) rather than in-person. The total N able to collect complete sets of post-treatment outcome measures were smaller than anticipated, but we were able to collect sufficient data to test the hypothesized ("Go-crtieria") effect.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony King, PhD | The Ohio State University | 7347094744 | anthony.king@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 24, 2020 | Mar 15, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000099025 | Mindfulness-Based Cognitive Therapy |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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treatment groups will consist of a minimum of 4 participants (preferably 5-8). The statistician will randomize the groups once a sufficient number of participants have enrolled to ensure desired group size.
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Statistician will not know the group assignment until blind is broken. Statistician randomizes the groups. Principal investigator will not know group assignment until blind is broken.
| Muscle Relaxation Therapy | Behavioral | 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. |
|
| pre-therapy and post therapy (approximately 9-10 weeks) |
| Columbus |
| Ohio |
| 43210 |
| United States |
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Resting-state functional connectivity btw posterior cingulate cortex (PCC) and dorsolateral PFC | Network functional connectivity will be measured through fMRI blood oxygen level dependent [BOLD] signal. Time-course of BOLD signal while participants are "resting" / not performing a task will be used identify brain regions whose activity time-course is correlated with a brain region of interest (ROI), called a "seed" ROI. We will use activity in the PCC as a seed ROI and search for regions of time-course correlation within the dlPFC, searching for dlPFC clusters within an anatomical mask of middle frontal cortex. Betas for identified dlPFC clusters will be extracted. | Mean | Standard Deviation | arbitrary (beta) |
|
| ID | Title | Description |
|---|
| OG000 | 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. |
| OG001 | 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. |
|
|
|
| Secondary | Change (From Intake to Post-therapy) in Resting-state Functional Connectivity (rsFC) Between Posterior Cingulate Cortex (PCC) and Insula Cortex (Insula) | 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. | We analyzed all subjects who had both a usable intake rsfMRI scan and a usable post-therapy rsfMRI scan (N=41) | Posted | Mean | Standard Error | Beta of BOLD rsFC change score | pre-therapy and post therapy (approximately 9-10 weeks) |
|
|
|
|
| 0 |
| 31 |
| 1 |
| 31 |
| 0 |
| 31 |
| EG001 | 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. 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. | 0 | 30 | 1 | 30 | 0 | 30 |
|
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| D004191 |
| Behavioral Disciplines and Activities |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 0.227 |
The a priori threshold for statistical significance was p < 0.025, adjusted for two comparisons (left and right insula) |
| Superiority |