Serving Women Using Opioids During Pregnancy

NCT03552120 | Terminated

• 1 other identifier: IRB_00099361
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Current Opioid Misuse Measure

  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)?"

  10 weeks

• Brief Child Abuse Potential Inventory

  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."

  10 weeks

Secondary Outcomes (2)

• Opioid Craving Visual Analog Scale

  10 weeks

• Depression, Anxiety and Stress Scale

  10 weeks

Study Arms (2)

Mindfulness

EXPERIMENTAL

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: MORE

Supportive Psychotherapy

ACTIVE COMPARATOR

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.

Behavioral: Supportive Psychotherapy

Interventions

MORE BEHAVIORAL

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.

Mindfulness

Supportive Psychotherapy BEHAVIORAL

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.

Supportive Psychotherapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Currently pregnant
• Taking opioids (prescription opioids, methadone, suboxone, heroin, kratom, etc.)
• Fluent in English

You may not qualify if:

• Past experiences with mindfulness-based stress reduction, mindfulness-based relapse prevention, mindfulness-based cognitive therapy
• Active suicidality
• Active psychosis

Sponsors & Collaborators

• University of Utah: lead
• Mind and Life Institute, Hadley, Massachusetts: collaborator

Study Sites (1)

The University of Utah

Salt Lake City, Utah, 84112, United States

Location

Study Officials

• Sarah Priddy, MSW

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: June 11, 2018
• Study Start: April 23, 2018
• Primary Completion: February 5, 2021
• Study Completion: February 5, 2021
• Last Updated: April 24, 2023

Record last verified: 2020-10

Locations

US (1)