Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for PTSD - COVID Related Substudy

The Ohio State University

Status: Completed

Conditions: Trauma

Treatments: Behavioral: Muscle Relaxation Therapy; Behavioral: Mindfulness-Based Cognitive Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04540939

HUM00152509-COVID Substudy

1R61AT009867 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This clinical trial is a sub-study to treat participants that were not eligible in the main study (HUM00152509/NCT03874793) to receive MBCT or MRT in hard hit COVID-19 areas with trauma history and current COVID-related distress.

The purpose of this treatment-only sub-study is to see how eligible participants with life history of any trauma and are currently experiencing elevated COVID-related stress are affected by two different PTSD therapies involving Mind-Body practices; Mindfulness based Cognitive Therapy (MBCT) and Muscle Relaxation Therapy.

The targeted individuals will reside in areas (Washtenaw, Wayne, and Oakland counties in Michigan, etc.) that have been affected by COVID-19. Participants will have assessments before and after 8 weeks of therapy (remote MBCT or MRT).

Full description

This clinical trial is a sub-study to treat participants that were not eligible in the main study (HUM00152509/NCT03874793) to receive MBCT or MRT in hard hit COVID-19 areas with trauma history and current COVID-related distress.

The purpose of this treatment-only sub-study is to see how eligible participants with life history of any trauma and are currently experiencing elevated COVID-related stress are affected by two different PTSD therapies involving Mind-Body practices; Mindfulness based Cognitive Therapy (MBCT) and Muscle Relaxation Therapy.

The targeted individuals will reside in areas (Washtenaw, Wayne, and Oakland counties in Michigan, etc.) that have been affected by COVID-19. Participants will have assessments before and after 8 weeks of therapy (remote MBCT or MRT).

Enrollment: 59 patients

Sex: All

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• COVID distress sample: resides in geographical area heavily impacted by COVID-19 have a history of trauma
• Has current elevated levels of COVID related stress and/or distress (worry, repetitive negative thinking) (COVID stress scale score > 15, worry / repetitive negative thinking, Penn State Worry Questionnaire (PSWQ) score >35 ).

Exclusion criteria

• PTSD
• Suicide risk
• Psychosis
• Life history of schizophrenia
• Current substance dependence
• Other factors that preclude safe and meaningful participation in the study, at discretion of the PI and study team

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 2 patient groups

Mindfulness-Based Cognitive Therapy (MBCT)

Experimental group

Description:

MBCT is a "mindfulness-based intervention" group intervention involving in session and at home practicve of mindfulness meditation and other mindfulness practices. There are8 sessions each with a specific theme and and these are \~2 hours long. Over the 8-weeks participants will learn several mindfulness meditation techniques. Each session will involve group discussion and feedback. Participants will be asked to practice these techniques at home, and keep a log of mood, and stress ratings. Audio files with exercises will be given to participants so that they can practice at home between sessions.

Treatment:

Behavioral: Mindfulness-Based Cognitive Therapy

Muscle Relaxation Therapy

Active Comparator group

Description:

PMR is a relaxation-based group intervention similar to other relaxation interventions commonly used for anxiety and PTSD. It involves in session and at home practicve of relaxation techniques including tensing and relaxing muscle groups, but no specifici mindfulness or meta-cogntive awaremess instructions. This PMR group has been designed as an active comparator with similar stucture to MBCT, but without mindfulness instruction. There are 8 sessions each with a specific theme and these are \~2 hours long. Over the 8-weeks participants will learn several relaxation techniques. Each session will involve group discussion and feedback. Participants will be asked to practice these techniques at home, and keep a log of mood, and stress ratings. Audio files with exercises will be given to participants so that they can practice at home between sessions.

Treatment:

Behavioral: Muscle Relaxation Therapy