Serving Women Using Opioids During Pregnancy

Summary

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.

Conditions

• Opioid Use
• Pregnancy Related

Interventions

BEHAVIORAL

MORE

MORE is a manualized integrative treatment strategy that targets transdiagnostic mechanisms in stress-related conditions. MORE is made up of three primary components: mindfulness training, cognitive restructuring, and savoring. Mindfulness training aims to increase attentional control to reduce cognitive bias toward negative information. Cognitive reappraisal promotes restructuring of maladaptive cognitions, which would otherwise intensify negative emotion and addictive behavior. Finally, MORE promotes savoring - mindful attention to and appreciation of pleasant events in life as a means of increasing positive emotion regulation.

BEHAVIORAL

Supportive Psychotherapy

Supportive psychotherapy is a form of non-directive talk therapy, which follows a Rogerian person-centered approach. The therapist's primary objectives during a session will be (1) to communicate unconditional positive regard for the participant, (2) to communicate engagement and empathic understanding, and (3) to mirror a participant's affect.

Sponsors & Collaborators

• Mind and Life Institute, Hadley, Massachusetts

  collaborator OTHER

• University of Utah

  lead OTHER

Principal Investigators

• Sarah Priddy, MSW · University of Utah

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-23

Primary Completion

2021-02-05

Completion

2021-02-05

Countries

• United States

Study Locations