Adapting the Penny Chatbot for Perinatal OUD Patients: COPILOT

Not Applicable

Not yet recruiting

• Conditions: Perinatal Opioid Use Disorder; Opioid Use Disorder

• Registration Number: NCT06969261
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-08
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-08
• Last Update Submitted: 2025-05-08
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-13
• Study Start: 2025-07-01
• Primary Completion: 2026-03-01
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
UCLA Loneliness Scale.	During Aim 3 activities, assessments will occur at Baseline and at 3-month Follow-up.	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.

Secondary Outcome Measures

Name	Time	Method
Opioid use questionnaire	During Aim 3 activities, assessments will occur at Baseline and 3-month Follow-up.	A questionnaire designed by our investigative team that queries a participant's opioid use, specifically identifying their drug of choice, method of administration, pattern of use, triggers for use, frequency and amount of use, barriers to relapse, and recency of relapse.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States