Serving Women Using Opioids During Pregnancy

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:

To assess for attentional bias to opioid-related and natural reward cues, investigators will
employ a dot probe task to measure reaction times (RTs) to target probes replacing neutral
photos compared with RTs to probes replacing opioid-related photos (e.g., pills, pill
bottles) and natural reward photos (e.g., smiling babies, food). Reward and neutral photos
will be selected from the International Affective Picture System and opioid-related photos
will be taken from media libraries on the internet. Equal proportions neutral/reward, and
neutral/opioid stimuli will be presented. Each pair of stimuli will be presented for 50 ms,
200 ms, or 2000 ms on either side of a fixation cross. A target probe will replace one of the
photos after a 50 ms interstimulus interval (ISI). Cue/target probe position and presentation
duration will be pseudo-randomized and counterbalanced. RTs and accuracy will be analyzed.

To measure emotion regulation and natural reward responsiveness, investigators will use a
well-validated emotion regulation task in which a trial will be composed of six parts. First,
a fixation cross will appear for 3-7 seconds. Then, a negative or positive emotional image
will appear for 2 seconds to elicit an emotional response. Next, a semi-transparent
instruction ("Reappraise," "Savor," or "Look") will appear below the image for 2 seconds. A
research assistant will instruct the participant before the task begins to down-regulate
emotion on negative affect trials and up-regulate emotion on positive affect trials. Next,
the image will appear alone on the screen for 6 seconds during which time participants will
implement the instructed strategy. Negative (e.g., angry faces, violent scenes) and positive
images (e.g., smiling persons, nature scenes) will be selected from the IAPS (M valence:
neg=2.7; pos=7.0) and equated on mean arousal (neg=5.3; pos=5.3). At the end of the trial,
participants will rate their affective response. Twelve trials of each event type will be
randomly presented over four 6-minute runs.

Psychophysiological responses (HR, HRV, SCR, RSA) during the dot probe and emotion regulation
tasks will be collected via ECG monitor, respiration belt, and Electrodermal Activity
Amplifier, and assessed with a BIOPAC psychophysiological data acquisition unit during the
dot probe and emotion regulation tasks. R-waves and SCRs will be inspected for artifacts and
corrected according to established guidelines. HR, and SCR cue-responses will be calculated
by subtracting mean values prior to cue onset from maxima during cue exposure as well as from
each 25ms epoch during photo presentation. Time domain and spectral HRV analyses will be
computed with FFT and autoregressive algorithms. HRV during task blocks will be compared to
5-min baseline and recovery periods.

Infant Cry Stimulus: Participants will be asked to watch a video during which an infant is
playing and smiling and then begins to cry. investigators will measure participants'
physiological reactions to watching the video. In the first three minutes of the video,
participants will watch a tranquil seascape scene during which baseline physiology will be
measured. Then, they will watch 35-seconds or the infant playing with her mother. Following
this interaction on the video, the mother stops playing with the infant who immediately
begins crying. She cries for 2.5 minutes. investigators refer to this segment as the infant
cry segment. This exact stimulus has been used in previous research and moderate increases in
heart rate and decreases in respiratory sinus arrhythmia (RSA) were observed, indicative of a
moderate response to stress.

After completing the pre-assessments, individuals will be randomly assigned to participate in
8 weeks of MORE or 8 weeks of supportive counseling visits using a validated control
condition protocol. MORE consists of three components: mindfulness, reappraisal, and
savoring. This intervention was developed specifically for individuals using opioids. The
supportive counseling control will be matched for time and attention from a professional. In
this condition, the therapist will actively listen and validate the participant's
experiences, but will not provide any coping skills training. The interventions will be
delivered in individual sessions either in the participant's home, at the College of Social
Work Bridge Training Clinic, or at the participant's medical clinic or substance use
facility. During the last session, the therapist will conduct a semi-structured interview
focused on the participant's experience of the intervention. During the last session, the
therapist will conduct a semi-structured interview focused on the participant's experience of
the intervention. Importantly, these sessions will be audio recorded and a random selection
will be assessed for treatment fidelity. The recordings will also be transcribed and analyzed
for themes.

After eight weeks of participating in MORE or supportive counseling, participants will
complete two post-treatment assessments mirroring the initial assessments. Part one will
consist of the opioid misuse assessment and self-report measures. Part two will consist of
the psychophysiological protocol.

The research assistants and Dr. Conradt will be notified via theradoc (email) when patient is
admitted to the hospital and is in labor. Investigators will collect the placenta within 4
hours of delivery using our established methods of placenta collection from IRB 81198 (BABY
study). Twenty-four hours after delivery we will conduct the standardized newborn
neurobeahvioral assessment (NNNS) which is currently being used in our NIH-funded research
and in IRB 81198 (BABY study).

When the child is five months old, the participant will return for a follow-up visit. This
assessment will include the opioid misuse assessment, a mother-baby interaction assessment,
and the Still Face Paradigm. Importantly, the mother-baby interaction and Still Face Paradigm
will be filmed to be assessed by a second research assistant. During the mother-baby
interaction assessment, a research assistant (blind to treatment condition) will behaviorally
code the mother-baby interaction while viewing this interaction from behind a one-way mirror.
During the interaction, research assistants will code discrete infant behaviors (e.g. the
amount of time the infant is crying during the interaction) and discrete mother behaviors
(e.g., the amount of time mother spends interacting insensitively with the infant).

During the Still Face Paradigm, the participant is instructed to interact normally with her
baby for two minutes, to then stop interacting with her baby for two minutes, and to then
resume interacting with her baby for two minutes. During this assessment, mother and baby
will be both be fit with ECG electrodes to measure heart rate.

Inclusion Criteria:

- Currently pregnant

- Taking opioids (prescription opioids, methadone, suboxone, heroin, kratom, etc.)

- Fluent in English

Exclusion Criteria:

- Past experiences with mindfulness-based stress reduction, mindfulness-based relapse
prevention, mindfulness-based cognitive therapy

- Active suicidality

- Active psychosis