Program for Pain & Prescription Opioid Use in Pregnancy
Condition: Pain; Opioid Abuse; Pregnancy
MeSH terms: Opioid-Related Disorders
Study type: Interventional

Summary: 
      Pregnant women using prescription opioid medication (pain medications) are invited to take
      part in a program for the reduction of pain and prescription opioid misuse.
    

Detailed description: 
      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.
    

Intervention name(s): CBT for Chronic Pain in Pregnancy
Intervention type(s): Behavioral
Intervention description(s): The content will be included in 8 weekly sessions, i.e., sessions 1-3 ("Education on chronic pain", "Theories of pain and diaphragmatic breathing" and "Progressive muscle relaxation and visual imagery"), sessions 4 and 5 ("Automatic thoughts and pain" and "Cognitive restructuring"), sessions 7, 8 and 10 ("Pleasant activity scheduling", "Time-based pacing" and "Sleep hygiene"), sessions 6 and 9 ("Stress management" and "Anger management"). Following this content, 1-2 sessions will be dedicated to review and reinforcement of key concepts or addressing any "stuck points" as well as cover content in session 11 ("Relapse Prevention"). The last session of therapy would include a review of achievements and commitment to continued application of CBT for chronic pain in participants daily lives.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pregnancy; pain; prescription opioid