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

Not Applicable

Completed

• Conditions: Trauma
• Interventions: Behavioral: Mindfulness-Based Cognitive Therapy; Behavioral: Muscle Relaxation Therapy

• Registration Number: NCT04540939
• Lead Sponsor: Ohio State University

Brief Summary

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).

Detailed 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).

Study Timeline

• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-04
• Study First Posted: 2020-09-07
• Study Start: 2020-10-19
• Primary Completion: 2023-03-30
• Study Completion: 2023-09-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-03
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-Based Cognitive Therapy (MBCT)	Mindfulness-Based Cognitive Therapy	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.
Muscle Relaxation Therapy	Muscle Relaxation Therapy	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.

Primary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes Measurement Information System (PROMIS-adult short form level 2) Anxiety survey	up to 8 weeks	This Anxiety-Adult measure 7-item PROMIS Anxiety Short Form assesses the pure domain of anxiety in individuals age 18 and older. The participants will select how often they have been bothered by symptoms during the past 7 days from 1=never to 5=always (the higher the score the more anxiety).
Penn State Worry Questionnaire (PSWQ-16) Worry survey	up to 8 weeks	The PSWQ is a well-validated self-administered, 16-item, Likert-type scale designed to measure worry. Possible range of scores is 16-80 with the algorithm of Total scores: 16-34 Low Worry, 35-59 Moderate, and 60-80 High Worry.
PROMIS (adult short form) Emotional Depression survey	up to 8 weeks	This is an 8 question survey where participants will select answers of 1= Never to 5= always. The higher the score the greater severity of depression.
Working Alliance Inventory- short revised (WAI-SR)	up to 8 weeks	This is a 12-item measure that assesses therapy clients' perception of working alliance with their therapists, developed by Adam Horvath with 3 factors of shared goals, tasks, and personal bond / regard. The participants select from Seldom= 1, Sometimes=2, Fairly often =3, Very often = 4, and Always = 5. The higher the score the higher working alliance.

Secondary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes Measurement Information System (PROMIS-adult short form level 2) Anxiety survey group differences (MBCT and PMR)	up to 8 weeks	This Anxiety-Adult measure 7-item PROMIS Anxiety Short Form assesses the pure domain of anxiety in individuals age 18 and older. The participants will select how often they have been bothered by symptoms during the past 7 days from 1=never to 5=always (the higher the score the more anxiety). This will look at the group differences between MBCT and PMR.
Penn State Worry Questionnaire (PSWQ-16) Worry survey group differences (MBCT and PMR)	up to 8 weeks	The PSWQ is a well-validated self-administered, 16-item, Likert-type scale designed to measure worry. Possible range of scores is 16-80 with the algorithm of Total scores: 16-34 Low Worry, 35-59 Moderate, and 60-80 High Worry. This will look at the group differences between MBCT and PMR.
PROMIS (adult short form) Emotional Depression survey group differences (MBCT and PMR)	up to 8 weeks	This is an 8 question survey where participants will select answers of 1= Never to 5= always. The higher the score the greater severity of depression. This will look at the group differences between MBCT and PMR.
Working Alliance Inventory- short revised (WAI-SR) group differences (MBCT and PMR)	up to 8 weeks	This is a 12-item measure that assesses therapy clients' perception of working alliance with their therapists, developed by Adam Horvath with 3 factors of shared goals, tasks, and personal bond / regard. The participants select from Seldom= 1, Sometimes=2, Fairly often =3, Very often = 4, and Always = 5. The higher the score the higher working alliance.This will look at the group differences between MBCT and PMR.

Trial Locations

Locations (2)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States