TraumaNCT04540939
Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for PTSD - COVID Related Substudy
A study testing Mindfulness-Based Cognitive Therapy and Muscle Relaxation Therapy in people with Trauma, run by Ohio State University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Trauma
- What is being tested?
- Mindfulness-Based Cognitive Therapy and Muscle Relaxation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Oct 2020to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ).
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48170
The Ohio State University
Columbus, Ohio, 43210
About this study
Official title: Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD) - COVID Substudy
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).
Read the 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).
- Conditions
- Trauma
- Being tested
- Mindfulness-Based Cognitive Therapy, Muscle Relaxation Therapy
- Keywords
- Mindfulness-Based Cognitive Therapy, Muscle Relaxation, Group Psychotherapy
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive TherapyBehavioural
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 TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Muscle Relaxation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: up to 8 weeks
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.
Measured: up to 8 weeks
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.
Measured: up to 8 weeks
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.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start19 Oct 2020
- Primary completion30 Mar 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of Michigan
- Responsible party
- Principal investigator, Anthony P King, Ohio State University
- Investigators
- Anthony King, Ph.D., Principal investigator, University of MichiganDavid Fresco, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540939
- Sponsor's protocol ID
- HUM00152509-COVID Substudy
- Other IDs
- 1R61AT009867
- Status last verified
- Mar 2024
- First submitted
- 4 Sep 2020
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD) - COVID Substudy
- ClinicalTrials.gov ID
- NCT04540939
- Acronym / sponsor ID
- HUM00152509-COVID Substudy
- Conditions
- Trauma
- Keywords
- Mindfulness-Based Cognitive Therapy, Muscle Relaxation, Group Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of Michigan
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Cognitive Therapy (MBCT) | Experimental | Behavioral: Mindfulness-Based Cognitive TherapyMBCT 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 | Active comparator | Behavioral: Muscle Relaxation TherapyPMR 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. |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 ).
Key exclusion criteria (6 listed)
- PTSD
- Suicide risk
- Psychosis
- Life history of schizophrenia
- Current substance dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Cognitive TherapyThere 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. | Behavioural | Mindfulness-Based Cognitive Therapy (MBCT) |
| Muscle Relaxation TherapyEach 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. | Behavioural | Muscle Relaxation Therapy |
Primary outcome
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.
4 secondary outcomes
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
Penn State Worry Questionnaire (PSWQ-16) Worry survey group differences (MBCT and PMR)
Time frame: up to 8 weeks
PROMIS (adult short form) Emotional Depression survey group differences (MBCT and PMR)
Time frame: up to 8 weeks
Working Alliance Inventory- short revised (WAI-SR) group differences (MBCT and PMR)
Time frame: up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony King, Ph.D. principal investigator
University of Michigan
David Fresco, PhD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive Therapy and Muscle Relaxation Therapy in people with Trauma, run by Ohio State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System (PROMIS-adult short form level 2) Anxiety survey (time frame: up to 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.