NCT02804152

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

2.5 years

First QC Date

May 10, 2016

Last Update Submit

April 4, 2022

Conditions

PainOpioid AbusePregnancy

Keywords

pregnancypainprescription opioid

Outcome Measures

Primary Outcomes (3)

  • Brief Pain Inventory (BPI)

    Pain Severity and Functioning

    change from baseline in BPI at 8 weeks, 1 month post treatment, and 6 weeks postpartum

  • Current Opioid Misuse Measure (COMM)

    opioid misuse behaviors

    change from baseline in COMM at 8 weeks, 1 month post treatment, and 6 weeks postpartum

  • Current Opioid Dose

    Use of opioid medications in pregnancy

    change from baseline in current opioid dose at 8 weeks, 1 month post treatment, and 6 weeks postpartum

Study Arms (1)

CBT for Chronic Pain

OTHER

single arm open-label design

Behavioral: CBT for Chronic Pain in Pregnancy

Interventions

CBT for Chronic Pain in PregnancyBEHAVIORAL

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.

CBT for Chronic Pain

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Medical University of South Carolina

Charleston, South Carolina, 29405, United States

Location

Related Publications (1)

  • Shapiro M, Sujan AC, Guille C. A Clinical Trial of a Program for Pain Management and Opioid Reduction During Pregnancy. Reprod Sci. 2022 Feb;29(2):606-613. doi: 10.1007/s43032-021-00701-4. Epub 2021 Aug 17.

    PMID: 34403125DERIVED

MeSH Terms

Conditions

PainOpioid-Related Disorders

Interventions

Pregnancy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2016

First Posted

June 17, 2016

Study Start

July 1, 2016

Primary Completion

January 1, 2019

Study Completion

July 1, 2019

Last Updated

April 6, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)