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

NCT04540939 | Completed

• 2 other identifiers: HUM00152509-COVID Substudy1R61AT009867
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

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).

Conditions

Trauma

Keywords

Mindfulness-Based Cognitive Therapy; Muscle Relaxation; Group Psychotherapy

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• Patient-Reported Outcomes Measurement Information System (PROMIS-adult short form level 2) Anxiety survey group differences (MBCT and PMR)

  up to 8 weeks

• Penn State Worry Questionnaire (PSWQ-16) Worry survey group differences (MBCT and PMR)

  up to 8 weeks

• PROMIS (adult short form) Emotional Depression survey group differences (MBCT and PMR)

  up to 8 weeks

• Working Alliance Inventory- short revised (WAI-SR) group differences (MBCT and PMR)

  up to 8 weeks

Study Arms (2)

Mindfulness-Based Cognitive Therapy (MBCT)

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based Cognitive Therapy

Muscle Relaxation Therapy

ACTIVE COMPARATOR

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.

Behavioral: Muscle Relaxation Therapy

Interventions

Mindfulness-Based Cognitive Therapy BEHAVIORAL

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.

Mindfulness-Based Cognitive Therapy (MBCT)

Muscle Relaxation Therapy BEHAVIORAL

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.

Muscle Relaxation Therapy

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ).

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• University of Michigan: collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48170, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Mindfulness-Based Cognitive Therapy

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Anthony King, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

• David Fresco, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and Behavioral Health

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 7, 2020
• Study Start: October 19, 2020
• Primary Completion: March 30, 2023
• Study Completion: September 1, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 36 months of completion of the project.
• Access Criteria: Access to data generated by the project will be available for educational, research and non-profit purposes to researchers who provide a methodologically sound proposal. Data generated under this project will be administered in accordance with NIH Sharing policies, including NIH Policy on Dissemination of NIH-Funded Clinical Trial Information (8/2016), and the NIH Grants Policy Statement (Availability of Research Results) (11/2015). Depending on such NIH policies, Data generated by this project may be available for educational, research or non-commercial purposes under the terms of a data use agreement. Data will be stored in an established data repository (e.g. Inter-university Consortium for Political and Social Research (ICPSR): icpsr.umich.edu) with appropriate provisions for curation and longterm preservation.

Locations

US (2)