Post Traumatic Stress Disorder
Conditions
Keywords
Mindfulness-Based Cognitive Therapy, Muscle Relaxation, fMRI, Group Psychotherapy
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMindfulness-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.
BEHAVIORALMuscle 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.
Sponsors
Ohio State University
National Center for Complementary and Integrative Health (NCCIH)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
No
Inclusion criteria
* Meets current Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for PTSD (with or without Major Depressive Disorder) or subsyndromal PTSD (has qualifying trauma, has intrusive and avoidant symptoms, and at least one negativity and one arousal symptom, and significant impairment); type of trauma shall be interpersonal violence, combat, and/or sexual assault, etc.
Exclusion criteria
* Dissociative PTSD * Delayed-onset PTSD * Magnetic Resonance Imaging (MRI) contraindications (e.g. metal in body, inability to be in the scanner - claustrophobia, severe back pain, etc.) * Serious medical or neurologic conditions (e.g. stroke, seizures) * Suicide risk * Psychosis * Life history of schizophrenia * Life history of bipolar disorder * Current substance dependence * Other factors that preclude safe and meaningful participation in the study, at discretion of the PI and study team
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change (From Intake to Post-therapy) in Resting-state Functional Connectivity Between Posterior Cingulate Cortex (PCC) and Dorsolateral Prefrontal Cortex (dlPFC) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change (From Intake to Post-therapy) in Resting-state Functional Connectivity (rsFC) Between Posterior Cingulate Cortex (PCC) and Insula Cortex (Insula) | pre-therapy and post therapy (approximately 9-10 weeks) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnthony King, Ph.D.
Ohio State University
PRINCIPAL_INVESTIGATORDavid Fresco, Ph.D
University of Michigan
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Resting-state functional connectivity btw posterior cingulate cortex (PCC) and dorsolateral PFC | 0.0010 arbitrary (beta) STANDARD_DEVIATION 0.0927 |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 30 |
| other Total, other adverse events | 0 / 31 | 0 / 30 |
| serious Total, serious adverse events | 1 / 31 | 1 / 30 |
Outcome results
None listed