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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04540939
• Other study ID #: HUM00152509-COVID Substudy
• Secondary ID: 1R61AT009867
• Status: Completed
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: March 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 1, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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

Related Conditions & MeSH terms

• Trauma

Intervention

Behavioral:
• Mindfulness-Based Cognitive Therapy
There will be 8 sessions and these will be approximately 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
Each MR session is approximately 2 hours. Over the 8-weeks you will learn how to relax your body using a step-by-step process in which you alternate between squeezing and relaxing your muscles. You will learn about your body's natural response to stress and how to use muscle relaxation during your everyday life. Each session will also involve group discussion and feedback. You will be asked to practice these techniques at home, and keep a log of your mood, and stress ratings. You will receive audio files with exercises so you can practice at home between sessions.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	The Ohio State University	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University	National Center for Complementary and Integrative Health (NCCIH), University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-Reported Outcomes Measurement Information System (PROMIS-adult short form level 2) Anxiety survey	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).	up to 8 weeks
Primary	Penn State Worry Questionnaire (PSWQ-16) Worry survey	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.	up to 8 weeks
Primary	PROMIS (adult short form) Emotional Depression survey	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.	up to 8 weeks
Primary	Working Alliance Inventory- short revised (WAI-SR)	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.	up to 8 weeks
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS-adult short form level 2) Anxiety survey group differences (MBCT and PMR)	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.	up to 8 weeks
Secondary	Penn State Worry Questionnaire (PSWQ-16) Worry survey group differences (MBCT and PMR)	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.	up to 8 weeks
Secondary	PROMIS (adult short form) Emotional Depression survey group differences (MBCT and PMR)	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.	up to 8 weeks
Secondary	Working Alliance Inventory- short revised (WAI-SR) group differences (MBCT and PMR)	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.	up to 8 weeks