Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD) - COVID Substudy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 4
- 主要终点
- Patient-Reported Outcomes Measurement Information System (PROMIS-adult short form level 2) Anxiety survey
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ).
排除标准
- •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
结局指标
主要结局
Patient-Reported Outcomes Measurement Information System (PROMIS-adult short form level 2) Anxiety survey
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- 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)
研究者
Anthony P King
Associate Professor of Psychiatry and Behavioral Health
Ohio State University