Program for Pain & Prescription Opioid Use in Pregnancy

Subjects: Participants will be 200 adult, pregnant women receiving prenatal care and using
POs for chronic pain. Women must be willing to consider a PO dose reduction, and cannot meet
criteria for a Substance Use Disorder. Specific inclusion and exclusion criteria can be found
in the Protections of Human Subjects section below.

Procedures: Pregnant women using POs will be identified by the obstetric care team, or
self-referred via study advertisements, and referred to study personnel. The obstetric care
team will serve as a referral source and will not be taking part in any research related
activities. Women will be scheduled to meet with study personnel either in-person, via
telemedicine or by phone and will undergo a brief eligibility screening. If women are
eligible they will be given a full description of the study procedures and asked to read and
sign an IRB-approved consent form in-person or consent online before any study procedures or
assessments are conducted using doxyme software. Ineligible women, or those not wanting to
take part will be referred for clinical treatment in-person or via telemedicine.

Baseline Visit: Eligible participants will complete online assessments (see primary outcome
assessments below) via a Redcap survey. They will have their cell phones registered into the
daily diary system described below and will be given instruction on how to respond to daily
queries regarding pain, functioning, craving, mood etc. Participants without a cell phone
will be provided a cell phone for use during the study. Eligible participants will complete
daily ratings for no more than 21 days.

Treatment Phase: Immediately following the 21 day data collection phase, subjects will take
part in 8, 75-minute sessions of the modified, individual CBT for Chronic Pain program. This
treatment will be delivered once weekly over 8 weeks by the study therapist. Participants
will continue their daily diary ratings and these will be reviewed by the study therapist and
participant each week during the therapy session. Subjects will not receive any other CBT
services during the study. All services received (e.g., pain management, self-help groups,
case management) will be carefully monitored and tracked at weekly visits.

Each week, following the CBT for Chronic Pain session, the participant will meet with the
study physician or APRN, for 15 minutes. PO use will be reviewed, symptoms of maternal or
fetal withdrawal will be assessed (see Safety Measures and Appendix for medication management
session) and based on the participant's preference, the provider will continue the same
prescribed regime of the PO medication(s) or decrease the overall dose by 20%- a safe and
recommended reduction of opioid medication during pregnancy14. Participant rational for their
individual decision will be recorded and the appropriate amount of PO medication will be
prescribed by the in-person provider or if via telemedicine, in collaboration with in-person
obstetric provider. Use of POs from other providers will be carefully monitored and tracked
at each weekly visit using the Prescription Drug Monitoring Program (PDMP) database and
review of the EMR (see Safety Measures). Following each weekly treatment session, the
participants will complete online assessments (see primary outcome assessments below) via a
Redcap survey.

Follow-up: Women will be asked to continue their daily ratings for one month after completing
the 8 week treatment. They will also be asked to complete an online assessment (see primary
outcome assessments below) via a Redcap survey at one month post-treatment. At 6 weeks
postpartum, women will be asked to complete their final online assessment (see primary
outcome assessments below) via a Redcap survey.

Inclusion Criteria:

- Adult females, any race or ethnicity, age 18-45 years.

- Pregnant and receiving prenatal care

- Willing to consider a decrease in their dose of their prescription opioid medication.

- Does not meet DSM-V criteria for a Substance Use Disorder.

- Able to comprehend English.

- Able to provide informed consent.

Exclusion Criteria:

- Unable to provide informed consent.

- Not currently pregnant, or receiving prenatal care

- Not currently taking a prescription opioid medication during pregnancy.

- Unwilling to consider a reduction in their prescription opioid medication dose.

- Meets DSM-V criteria for a Substance Use Disorder.

- Participation is not recommended by the participant's primary obstetrician