Clinical trial NCT04540939: Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for PTSD - COVID Related Substudy
Official title: Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD) - COVID Substudy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Keywords: Mindfulness-Based Cognitive Therapy
Muscle Relaxation
Group Psychotherapy
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: University of Michigan
First posted: 2020-09-07
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-adult short form level 2) Anxiety survey
timeFrame: up to 8 weeks
measure: Penn State Worry Questionnaire (PSWQ-16) Worry survey
timeFrame: up to 8 weeks
measure: PROMIS (adult short form) Emotional Depression survey
timeFrame: up to 8 weeks
measure: Working Alliance Inventory- short revised (WAI-SR)
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-adult short form level 2) Anxiety survey group differences (MBCT and PMR)
timeFrame: up to 8 weeks
measure: Penn State Worry Questionnaire (PSWQ-16) Worry survey group differences (MBCT and PMR)
timeFrame: up to 8 weeks
measure: PROMIS (adult short form) Emotional Depression survey group differences (MBCT and PMR)
timeFrame: up to 8 weeks
measure: Working Alliance Inventory- short revised (WAI-SR) group differences (MBCT and PMR)
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: University of Michigan
name: Anthony King, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: David Fresco, PhD
role: PRINCIPAL_INVESTIGATOR
References: