Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD) - COVID Related Substudy
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04540939 |
|
Recruitment Status :
Recruiting
First Posted : September 7, 2020
Last Update Posted : February 14, 2022
|
Sponsor:
University of Michigan
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Ohio State University
Information provided by (Responsible Party):
Anthony King, University of Michigan
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Trauma | Behavioral: Mindfulness-Based Cognitive Therapy Behavioral: Muscle Relaxation Therapy | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Investigator, Outcomes Assessor) |
| Masking Description: | 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. |
| Primary Purpose: | Treatment |
| Official Title: | Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD) - COVID Related Substudy |
| Actual Study Start Date : | October 19, 2020 |
| Estimated Primary Completion Date : | May 2022 |
| Estimated Study Completion Date : | June 2022 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Mindfulness-Based Cognitive Therapy |
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. |
| Experimental: Muscle Relaxation Therapy |
Behavioral: 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. |
Primary Outcome Measures :
- Patient-Reported Outcomes Measurement Information System (PROMIS-adult short form level 2) Anxiety survey [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 :
- Patient-Reported Outcomes Measurement Information System (PROMIS-adult short form level 2) Anxiety survey group differences (MBCT and PMR) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 72 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04540939
Contacts
| Contact: Jung Park, BS | 734-615-5249 | jungp@med.umich.edu | |
| Contact: Anthony King, Ph.D. | 614-688-9537 | anthony.king@osumc.edu |
Locations
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48170 | |
| Contact: Jung Park 734-615-5249 jungp@umich.edu | |
| United States, Ohio | |
| The Ohio State University | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Anthony P King, PhD 614-688-9537 anthony.king@osumc.edu | |
| Contact: Alexis Berry, BS 614-688-9537 alexis.berry@osumc.edu | |
Sponsors and Collaborators
University of Michigan
National Center for Complementary and Integrative Health (NCCIH)
Ohio State University
Investigators
| Principal Investigator: | Anthony King, Ph.D. | University of Michigan | |
| Principal Investigator: | David Fresco, PhD | University of Michigan |
| Responsible Party: | Anthony King, Assistant Professor of Psychiatry, Medical School and Faculty Associate, Research Center for Group Dynamics, Institute for Social Research, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT04540939 |
| Other Study ID Numbers: |
HUM00152509-COVID Substudy 1R61AT009867 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 7, 2020 Key Record Dates |
| Last Update Posted: | February 14, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | We plan to make available data from human subjects initially to collaborators for independent replication / data pooling. Completely de-identified research data (redacted according to NIH practice to prevent disclosure of personal identifiers) which documents the research findings will be made available after the main findings from the finalized research dataset have been accepted for publication. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Anthony King, University of Michigan:
|
Mindfulness-Based Cognitive Therapy Muscle Relaxation Group Psychotherapy |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Mental Disorders |