Adapting the Penny Chatbot for Perinatal OUD Patients: COPILOT

NCT06969261 | Recruiting

• 2 other identifiers: 853729R34DA058461
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

To address both loneliness and engagement in perinatal and OUD care among perinatal women, the investigators plan to adapt an existing texting support chatbot, Penny, to make it appropriate for use by women who are pregnant and postpartum and dealing with OUD. The newly adapted chatbot, Penny COPILOT, will allow for two way short message service (SMS) messaging to respond appropriately and accurately to user generated input. The investigative team, in collaboration with the Penn Mixed Methods Research Lab (MMRL) and Penn's Way 2 Health Team, will use intervention mapping guided by the Consolidated Framework for Implementation Science. The investigators will conduct a needs assessment, assemble an advisory board, engage in pretesting to ensure safety and refine content, and pilot test the resultant adapted Penny COPILOT in a sample of 20 perinatal women with OUD to evaluate acceptability, feasibility, and patient satisfaction. The goal is to develop and refine an acceptable, feasible, and satisfactory supportive texting chatbot to promote patient engagement in perinatal and OUD care and decrease perceived loneliness.

Conditions

Perinatal Opioid Use Disorder; Opioid Use Disorder

Keywords

Maternal Health; Maternal Substance Use; Perinatal OUD; Chatbot; mHealth Interventions; Loneliness

Outcome Measures

Primary Outcomes (1)

• UCLA Loneliness Scale.

  The UCLA Loneliness Scale (Version 3) is the most commonly used measure of loneliness, with strong test-retest reliability, high internal consistency, and validity.97 While the word "lonely" is never used explicitly in the 20-item scale, subjects are asked to report the frequency of specific experiences (e.g., "How often do you feel in tune with others around you?") on a 4-point Likert scale (1 = "I never feel this way" to 4 = "I often feel this way.") For dichotomous analysis of loneliness, we will use the loneliness severity threshold adapted from Doryab98 which defines "lonely" as having a score greater than 40, while "not lonely" is defined as having a score less than or equal to 40.

  During Aim 3 activities, assessments will occur at Baseline and at 3-month Follow-up.

Secondary Outcomes (1)

• Opioid use questionnaire

  During Aim 3 activities, assessments will occur at Baseline and 3-month Follow-up.

Study Arms (1)

Chatbot Intervention

EXPERIMENTAL

This is a single arm study designed to assess the acceptability and feasibility of the chatbot.

Behavioral: Penny COPILOT

Interventions

Penny COPILOT BEHAVIORAL

The Penny COPILOT chatbot is an interactive short messaging system (SMS) program that provides educational and supportive content for postpartum individuals. The chatbot has been adapted to include information relevant to opioid use disorder recovery in order to decrease the risk of returning to use among people who use drugs. Messages are sent at specified intervals relevant to the postpartum course and the chatbot allows for two way messaging with an interactive lens.

Chatbot Intervention

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Biological females who are currently pregnant or within 6 weeks postpartum.
• Able to read, write, and speak English at a 6th grade level.
• Diagnosed and receiving treatment for, or willing to receive treatment for opioid use disorder.
• Receiving prenatal care and OUD care at a Penn affiliated hospital.

You may not qualify if:

• Current untreated psychosis, mania, or active suicidality as assessed by the Mini International Neuropsychiatric Interview (MINI).

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Hospital of the University of Pennsylvania (HUP)

Philadelphia, Pennsylvania, 19072, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-3309, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Sara L Kornfield, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara L Kornfield, PhD

CONTACT

1-800-789-7366; sarakorn@pennmedicine.upenn.edu

Study Design

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

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: May 13, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (2)