Accelerating Implementation of Mindful Mood Balance For Moms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 423
- 试验地点
- 8
- 主要终点
- Reach
研究概览
简要总结
The Mindful Mood Balance for Moms (MMBFM) study examines whether using an internet program called Mindful Mood Balance for Moms to deliver Mindfulness Based Cognitive Therapy (MBCT) over an 8-week time period, is effective for reducing depression symptoms among pregnant women with a history of prior depression, and studies the effects of implementation strategies on the reach of the MMBFM program. This study will enroll 470 women from Kaiser Permanente Colorado, Southern California, Georgia.
The investigators will compare clinical outcomes between those that receive mental health clinician coaching and those that receive peer coaching throughout the 8-week program. Survey data will be collected at 4 time points throughout the study (baseline, 12 weeks, 3rd trimester, and 3 months postpartum). The cost-effectiveness of both the clinical and peer coaching models at each health care system will be evaluated.
For the implementation portion of the study, 30 OB clinics across the 4 health systems will be randomized in equal numbers to provide clinician facing implementation strategies (e.g., recruitment flyers, script pads, electronic medical record prompts) to encourage engagement in the MMBFM program or to usual care where women are only recruited by the study team with no clinician involvement. The primary outcome for testing clinician facing implementation strategies is reach, the percentage of women outreached who initially engage in the MMBFM program.
详细描述
Specific Aims
Informed by the Consolidated Framework for Implementation Research, a leading implementation science framework, this hybrid type III effectiveness implementation study will evaluate specific implementation strategies for MMBFM. Consistent with a hybrid type III study, there are two goals: (1) compare the clinical effectiveness of MMBFM supported by mental health clinician vs. peer coaches in a randomized trial of 470 pregnant women; and (2) compare the reach of MMBFM across OB clinics for two sets of implementation strategies to facilitate access to and initial engagement in MMBFM: patient facing strategies (PFS - direct outreach to women following prenatal visits via secure patient portal, email, text, or mail) vs. patient facing strategies combined with clinician facing strategies (PFS+CFS - Electronic Medical Record (EMR)-embedded prompts for OB providers, printed prescription pads for providers, flyers). A cluster randomized design will be used, randomizing 30 OB clinics across 4 health systems to either of these two implementation conditions, to assess their impact on reach. The investigators will address the following specific aims:
Aim 1: Compare the clinical effectiveness (i.e. engagement and symptom reduction) of MMBFM supported by clinician vs. peer coaches among women with a history of prior depressive episodes. Hypothesis 1: Coaching delivered by mental health clinicians vs. peers with lived experience will be associated with equivalent reductions in depressive symptoms at 6 months post-randomization.
Aim 2: Examine specific mechanisms of action for MMBFM participants receiving clinician vs. peer coaching. Hypothesis 2a: MMBFM participants receiving peer coaching will report less self-stigma and social isolation than those receiving clinician coaching, and MMBFM participants receiving clinician coaching will report less ruminative response to negative affect and greater decentering at 6 months post-randomization than those receiving peer coaching. Hypothesis 2b: Any difference between peer and clinician coaching in depression outcomes will be mediated by treatment-specific targets - at least partially via increased engagement.
Aim 3: Examine the effects of specific implementation strategies on reach of the MMBFM program. Hypothesis 3: Clinician facing implementation strategies (CFS) in combination with patient facing strategies (PFS) will lead to higher rates of reach than patient facing strategies alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Aged 18 years or older, receiving prenatal care at one of the 4 participating health systems
- •12-24 weeks gestation
- •>= 1 prior episode of major depressive disorder, self-reported
- •Current Patient Health Questionnaire 9-item (PHQ9) depression score <=
- •Have internet access through home computer, smart phone, or similar device
排除标准
- •Non-English speaking
- •Past history of a psychotic, bipolar disorder, or substance misuse disorder within the past 6 months
- •Immediate risk of self-harm
- •PHQ9 score <5 or >9
- •Patients who are on the "do not call" list for research
结局指标
主要结局
Reach
时间窗: 6 months post-intervention involving patient facing vs. clinician facing implementation strategies
The percentage of participants who initially engage in the Mindful Mood Balance for Moms course.
Change in Patient Health Questionnaire 9-item (PHQ-9) scores from baseline through 3 months postpartum
时间窗: Baseline, 3 months post-randomization, 3rd trimester, 3 months postpartum
Depression symptom severity, scores range from 0 (low) to 27 (high)
次要结局
- Change in Perceived Stress Scale scores from baseline through 3 months postpartum(Baseline, 3 months post-randomization, 3rd trimester, 3 months post partum)
- Client Satisfaction Questionnaire (CSQ)(3 months post-randomization)
- Change in Attitudes Toward Motherhood (AToM) Scale scores from baseline through 3 months postpartum(Baseline, 3 months post-randomization, 3rd trimester, 3 months post partum)
- Change in Short Form 12 (SF-12) scores from baseline through 3 months postpartum(Baseline, 3 months post-randomization, 3rd trimester, 3 months post partum)
- The TWente Engagement with Ehealth Technologies Scale (TWEETS)(3 months post-randomization)
- Change in Generalized Anxiety Disorder 7-item (GAD-7) questionnaire scores from baseline through 3 months postpartum(Baseline, 3 months post-randomization, 3rd trimester, 3 months postpartum)