The Impact of a Mindfulness-based Intervention on Opioid Use During Pregnancy: A Mixed Methods Pilot RCT
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Current Opioid Misuse Measure
研究概览
简要总结
The purpose of this study is to evaluate the effects of Mindfulness-Oriented Recovery Enhancement (MORE) on opioid misuse and parenting behavior among pregnant women using opioids.
Specific aims are:
AIM 1: To evaluate the preliminary efficacy of MORE, relative to a supportive counseling control condition, on primary outcomes (opioid misuse) and secondary outcomes (opioid craving, psychological distress) among pregnant women using opioids. Hypothesis: Participants who participate in MORE will demonstrate significantly greater improvements than the supportive visit control group on: opioid misuse behaviors, opioid craving, and psychological distress.
AIM 2: To test and quantify the degree to which the impact of MORE on opioid misuse is mediated by changes in cognitive, affective, and autonomic mechanisms relevant to this clinical population - including opioid attentional bias, negative emotion regulation, reward responsiveness, and physiological reactivity to infant cues. Hypothesis: The impact of MORE on craving and opioid misuse behaviors will be mediated by improvements in attentional bias toward opioid cues, negative emotion regulation and natural reward responsiveness on the emotion regulation task, and autonomic reactivity to infant cues.
AIM 3: To evaluate the impact of MORE on mothers' perceptions of their ability to parent effectively and the quality of the mother-baby relationship. Hypothesis: Participants participating in MORE will report more positive beliefs about their ability to effectively parent. Participants who participated in MORE will interact more sensitively with their newborn.
Exploratory AIM 1: To evaluate the efficacy of MORE, relative to a support group control condition, on co-regulation, as measured by an index of sympathetic nervous system functioning, among pregnant women using opioids. Hypothesis 1: Dyads in which the mother participated in MORE will demonstrate significantly greater dyadic synching of sympathetic activity as measured by respiratory sinus arrhythmia (RSA).
Exploratory AIM 2: To test and quantify the degree to which the impact of MORE on dyadic synchrony (during the Still Face Paradigm) is mediated by changes in negative emotion regulation and reward responsiveness. Hypothesis 2: The impact of MORE on dyadic synchrony will be mediated by improvements in negative emotion regulation and natural reward responsiveness as measured by an emotion regulation task.
详细描述
Investigators will use an embedded mixed methods design including semi-structured qualitative interviews before the intervention, after the intervention, and five months following the post-intervention assessment. For the quantitative component, investigators will use a single-blind randomized controlled design to compare within participant and between group (i.e., mindfulness vs. supportive counseling control) changes in opioid misuse and craving as well as the quality of the mother-baby relationship. Psychophysiology will be used to assess the neurocognitive and autonomic mediators of treatment effects.
After determining eligibility, participants will be consented by the Principal Investigator or a research assistant. During the consent visit, individuals will also participate in a structured psychiatric interview, an opioid misuse assessment, and self-report measures. During a second visit, individuals will complete a psychophysiological protocol. All assessments will be conducted in the participant's home, at the University of Utah College of Social Work in Dr. Eric Garland's lab and the Bridge Training Clinic, or at the participant's physician's office or substance use treatment facility.
Psychiatric interview and opioid misuse assessment: Mini-International Neuropsychiatric Interview 6.0 and Addiction Behaviors Checklist.
Self report measures: The following validated questionnaires will be administered: Brief Pain Inventory; Current Opioid Misuse Measure; Opioid Craving Visual Analogue Scale; Depression Anxiety Stress Scale; Five Facet Mindfulness Questionnaire; Cognitive Emotion Regulation Questionnaire; Brief Savoring Beliefs Inventory; Attention to Positive and Negative Information Scale; Multidimensional Assessment of Interoceptive Ability; Coping Strategies Questionnaire; Ways of Savoring Checklist; Maternal Antenatal Attachment Scale; the Parenting Stress Index; the Edinburgh Postnatal Depression Scale; the Interpersonal Mindfulness in Parenting Scale - Infant Version; the Parental Evaluation Scale; the Self-Compassion Scale; Brief Child Abuse Potential Inventory.
Psychophysiological protocol:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Currently pregnant
- •Taking opioids (prescription opioids, methadone, suboxone, heroin, kratom, etc.)
- •Fluent in English
排除标准
- •Past experiences with mindfulness-based stress reduction, mindfulness-based relapse prevention, mindfulness-based cognitive therapy
- •Active suicidality
- •Active psychosis
结局指标
主要结局
Current Opioid Misuse Measure
时间窗: 10 weeks
The Current Opioid Misuse Measure misuse (COMM; α = .83) is a 17-item scale developed to help physicians identify patients misusing their prescribed opioids. Examples of items include: "In the past 30 days, how often have you needed to take pain medications belonging to someone else?" and, "In the past 30 days, how often have you used your pain medicine for symptoms other than for pain (e.g., to help your sleep, improve your mood, or relieve stress)?"
Brief Child Abuse Potential Inventory
时间窗: 10 weeks
The Brief Child Abuse Potential Inventory (B-CAP; α = .89) was developed from the Child Abuse Potential Inventory to identify in a briefer time period individuals at risk for committing child abuse. The B-CAP is a 24-item self-report scale with disagree and agree responses. Items include "Children should never disobey", "Children should be quiet and listen", and "A child needs very strict rules."
次要结局
- Opioid Craving Visual Analog Scale(10 weeks)
- Depression, Anxiety and Stress Scale(10 weeks)