Exploring Mechanisms of Change in a Pilot Randomized Trial of Mindfulness-Based Cognitive Therapy to Promote Well-being During Pregnancy and Postpartum Among At-risk Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in anxiety symptoms from 8 weeks to 3 months
研究概览
简要总结
The proposed study seeks to elucidate the mechanisms underlying Mindfulness-Based Cognitive Therapy in pregnancy to improve understanding of how and why this treatment modality enhances well-being, which can then be leveraged to optimize treatment for psychological distress emerging during this vulnerable period.
详细描述
Pregnancy and postpartum is a period of vulnerability for new or worsening psychiatric symptoms. Mindfulness Based Cognitive Therapy (MBCT) is an effective approach to mitigate pregnancy-related worsening of psychological distress. However, prior research has focused predominantly on symptoms of depression and anxiety, and is it not clear how or why MBCT improves psychological health during the perinatal period. Thus, the goals of this project are to (1) examine whether MBCT improves psychological functioning among pregnant women and whether these improvements persist at three-months postpartum, (2) examine whether improved ability to regulate emotions and behavior accounts for the beneficial effects of MBCT, and (3) determine what demographic, socioeconomic, and psychosocial factors impact treatment engagement and effectiveness.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnancy between 12 and 30 weeks gestation
- •reporting at least mild psychological distress (based on self-report)
- •access to high-speed internet or cellular network access
- •located in the U.S.
排除标准
- •current suicidal or homicidal ideation as assessed verbally during screening
- •symptom severity necessitating a higher level of clinical care
- •current psychosis
- •untreated mania
- •active substance abuse
- •lack of high-speed internet connection or cellular network access
- •planning to be traveling without access to internet for more than two weeks in the next 12 months
研究组 & 干预措施
Mindfulness-Based Cognitive Therapy (MBCT)
MBCT will be delivered in a group based, videoconference format with 90 minute sessions 1x/week.
干预措施: Mindfulness-Based Cognitive Therapy (MBCT) (Behavioral)
Treatment as Usual (TAU)
TAU, or the control group, provides information about the benefits of mindfulness in pregnancy, offers referrals for psychotherapy in the community, and involves monthly phone or videoconference calls to maintain engagement.
干预措施: Treatment as Usual (TAU) (Behavioral)
结局指标
主要结局
Change in anxiety symptoms from 8 weeks to 3 months
时间窗: 8 weeks and 3 months
Change in anxiety symptoms from 8 weeks to 3 months will be measured using the 16-item Penn State Worry Questionnaire (PSWQ). Questions 2, 4-7, 9, and 12-16 on the PSWQ are scored 1-5. Questions 1, 3, 8, 10, and 11 on the PSWQ are reverse scored 5-1. Total scores on the PSWQ are calculated by summing the score for each question. Total scores on the PSWQ range from 16-80, with higher scores indicating higher worry. Scores ranging from 16-39 would be considered low worry, scores ranging from 40-59 would be considered moderate worry, and scores ranging from 60-80 would be considered high worry.
Change in perceptions of daily life stress from baseline to 8 weeks
时间窗: baseline and 8 weeks
Change in the perceptions of daily life stress from baseline to 8 weeks will be measured using the 10-item Perceived Stress Scale (PSS). Questions 1, 2, 3, 6, 9, and 10 on the PSS are scored 0, 1, 2, and 3. Questions 4, 5, 7, and 8 on the PSS are reverse scored 3, 2, 1, and 0. Total scores on the PSS are calculated by summing the score for each question. Total scores on the PSS range from 0-40, with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress, scores ranging from 14-26 would be considered moderate stress, and scores ranging from 27-40 would be considered high perceived stress.
Change in rumination from baseline to 8 weeks
时间窗: baseline and 8 weeks
Change in rumination from baseline to 8 weeks will be measured using the 10-item Ruminative Response Scale (RRS-10). Questions 1-10 on the RRS-10 are scored 1-4. Total scores on the RRS-10 are calculated by summing the score for each question. Total scores on the RRS-10 range from 1-40, with higher scores indicating higher rumination.
Change in anxiety symptoms from baseline to 8 weeks
时间窗: baseline and 8 weeks
Change in anxiety symptoms from baseline to 8 weeks will be measured using the 16-item Penn State Worry Questionnaire (PSWQ). Questions 2, 4-7, 9, and 12-16 on the PSWQ are scored 1-5. Questions 1, 3, 8, 10, and 11 on the PSWQ are reverse scored 5-1. Total scores on the PSWQ are calculated by summing the score for each question. Total scores on the PSWQ range from 16-80, with higher scores indicating higher worry. Scores ranging from 16-39 would be considered low worry, scores ranging from 40-59 would be considered moderate worry, and scores ranging from 60-80 would be considered high worry.
Change in mindfulness from baseline to 8 weeks
时间窗: baseline and 8 weeks
Change in mindfulness from baseline to 8 weeks will be measured using the 39-item Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ consists of five subscales, which are calculated by summing the following questions, which are scored 1-5 (questions followed by "R" are reverse scored 5-1): observing = questions 1, 6, 11, 15, 20, 26, 31, and 36; describing = 2, 7, 12R, 16R, 22R, 27, 32, and 37; acting with awareness = 5R, 8R, 13R, 18R, 23R, 28R, 34R, and 38R; nonjudging of inner experience = 3R, 10R, 14R, 17R, 25R, 30R, 35R, and 39R; nonreactivity to inner experience = 4, 9, 19, 21, 24, 29, and 33. For the FFMQ subscales, scores can range from 8 to 40, except for non-reactivity to inner experience, which can range from 7 to 35. For the FFMQ subscales, higher scores represent higher subscale levels of mindfulness. Total scores are calculated by summing the subscale scores and range from 39-195, with higher scores indicating higher overall levels of mindfulness.
Change in presence and severity of depressive symptoms from baseline to 8 weeks
时间窗: baseline and 8 weeks
Change in the presence and severity of depressive symptoms from baseline to 8 weeks will be measured using the 10-item Edinburgh Postnatal Depression Scale (EPDS), a widely used instrument validated in pregnancy and the postpartum period. Questions 1, 2, 3, and 4 on the EPDS are scored 0, 1, 2, or 3 with the top box scored as 0 and the bottom box scored as 3. Questions 3 and 5-10 on the EPDS are reverse scored with the top box scored as 3 and the bottom box scored as 0. Total scores on the EPDS are calculated by summing the score for each question. Total scores on the EPDS range from 0-30, with a score of 10 or greater indicating possible depression and higher scores indicating greater severity of possible depression.
Change in presence and severity of depressive symptoms from 8 weeks to 3 months
时间窗: 8 weeks and 3 months
Change in the presence and severity of depressive symptoms from baseline to 3 months will be measured using the 10-item Edinburgh Postnatal Depression Scale (EPDS), a widely used instrument validated in pregnancy and the postpartum period. Questions 1, 2, 3, and 4 on the EPDS are scored 0, 1, 2, or 3 with the top box scored as 0 and the bottom box scored as 3. Questions 3 and 5-10 on the EPDS are reverse scored with the top box scored as 3 and the bottom box scored as 0. Total scores on the EPDS are calculated by summing the score for each question. Total scores on the EPDS range from 0-30, with a score of 10 or greater indicating possible depression and higher scores indicating greater severity of possible depression.
Change in perceptions of daily life stress from 8 weeks to 3 months
时间窗: 8 weeks and 3 months
Change in the perceptions of daily life stress from 8 weeks to 3 months will be measured using the 10-item Perceived Stress Scale (PSS). Questions 1, 2, 3, 6, 9, and 10 on the PSS are scored 0, 1, 2, and 3. Questions 4, 5, 7, and 8 on the PSS are reverse scored 3, 2, 1, and 0. Total scores on the PSS are calculated by summing the score for each question. Total scores on the PSS range from 0-40, with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress, scores ranging from 14-26 would be considered moderate stress, and scores ranging from 27-40 would be considered high perceived stress.
Change in rumination from 8 weeks to 3 months
时间窗: 8 weeks and 3 months
Change in rumination from 8 weeks to 3 months will be measured using the 10-item Ruminative Response Scale (RRS-10). Questions 1-10 on the RRS-10 are scored 1-4. Total scores on the RRS-10 are calculated by summing the score for each question. Total scores on the RRS-10 range from 1-40, with higher scores indicating higher rumination.
Change in rates of psychiatric diagnoses from baseline to 3 months
时间窗: baseline and 3 months
Change in rates of psychiatric diagnoses from baseline to 3 months will be measured using the Structured Clinical Interview for DSM-5 (SCID-5). The SCID-5 consists of a semistructured interview administered to participants by a clinician or trained mental health professional to determine participants' current and previous psychiatric diagnoses.
Change in mindfulness from 8 weeks to 3 months
时间窗: 8 weeks and 3 months
Change in mindfulness from 8 weeks to 3 months will be measured using the 39-item Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ consists of five subscales, which are calculated by summing the following questions, which are scored 1-5 (questions followed by "R" are reverse scored 5-1): observing = questions 1, 6, 11, 15, 20, 26, 31, and 36; describing = 2, 7, 12R, 16R, 22R, 27, 32, and 37; acting with awareness = 5R, 8R, 13R, 18R, 23R, 28R, 34R, and 38R; nonjudging of inner experience = 3R, 10R, 14R, 17R, 25R, 30R, 35R, and 39R; nonreactivity to inner experience = 4, 9, 19, 21, 24, 29, and 33. For the FFMQ subscales, scores can range from 8 to 40, except for non-reactivity to inner experience, which can range from 7 to 35. For the FFMQ subscales, higher scores represent higher subscale levels of mindfulness. Total scores are calculated by summing the subscale scores and range from 39-195, with higher scores indicating higher overall levels of mindfulness.
次要结局
- Change in attention from baseline to 8 weeks(baseline and 8 weeks)
- Change in disinhibition from baseline to 8 weeks(baseline and 8 weeks)
- Change in disinhibition from 8 weeks to 3 months(8 weeks and 3 months)
- Change in emotion regulation from baseline to 8 weeks(baseline and 8 weeks)
- Change in attention from 8 weeks to 3 months(8 weeks to 3 months)
- Change in cognitive inflexibility from baseline to 8 weeks(baseline to 8 weeks)
- Change in cognitive inflexibility from 8 weeks to 3 months(8 weeks to 3 months)
- Change in emotion regulation from 8 weeks to 3 months(8 weeks and 3 months)
研究者
Michele Levine
Professor
University of Pittsburgh