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Completed

NCT Number: NCT03874793

Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD)

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.

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change (From Intake to Post-therapy) in Resting-state Functional Connectivity Between Posterior Cingulate Cortex (PCC) and Dorsolateral Prefrontal Cortex (dlPFC)

    Time frame: 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 outcomes

  1. Change (From Intake to Post-therapy) in Resting-state Functional Connectivity (rsFC) Between Posterior Cingulate Cortex (PCC) and Insula Cortex (Insula)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • University of Michigan

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Mar 14, 2019
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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