Open Pilot Trial of Adapted Cognitive Processing Therapy for Comorbid PTSD and Opioid Use Disorder

Not Applicable

Not yet recruiting

• Conditions: Posttraumatic Stress Disorder (PTSD); Opioid Use Disorder

• Registration Number: NCT06872164
• Lead Sponsor: The City College of New York

Brief Summary

The goal of this open pilot trial is to learn if an adapted version of Cognitive Processing Therapy (CPT), delivered through telehealth, can treat posttraumatic stress disorder (PTSD) in adults who use syringe services programs. The main questions it aims to answer are:

* Can the intervention be done in syringe services programs?

* Are syringe services program clients and staff open to the intervention?

* Can the intervention lower PTSD symptoms and help participants keep taking their medication for opioid use disorder (ex. Buprenorphine or methadone)?

Participants will:

* Attend 4-18 tele-delivered CPT sessions at the syringe services program

* Complete between-session CPT practice with the support of SSP-based "coaches"

* Meet with research staff monthly to complete surveys of their PTSD symptoms, drug use, and mental health

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-10
• Study First Posted: 2025-03-12
• Last Update Posted: 2025-03-12
• Study Start: 2025-06-02
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Over the age of 18
• Regular syringe services program attendance (ex. at least 4 visits in the past month)
• Meeting DSM-5 opioid use disorder criteria
• Having been prescribed a medication for opioid use disorder in the past 30 days at the time of screening
• Criterion A event as measured by the Life Events Checklist for DSM-5 (LEC-5)
• PTSD symptoms at the level of a PTSD diagnosis as evidenced by a score of 31 or greater on the PTSD Checklist for DSM-5 (PCL-5)
• Ability to understand English
• Consent to have assessment interviews audio recorded and teletherapy sessions video recorded for research purposes
• Ability to provide informed consent

Exclusion Criteria

• High risk for suicidal thoughts and/or behaviors that would make participation dangerous, as measured by the Columbia Suicide Severity Rating Scale Lifetime-Recent Screen
• Meeting DSM-5 criteria for a current psychotic or bipolar disorder.
• Cognitive impairment liable to interfere with completion of study procedures
• Currently receiving trauma-focused psychotherapy (i.e. Prolonged Exposure, Cognitive Processing Therapy).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of Eligible Participants	Baseline	Proportion of persons eligible to enroll in the study of all possible SSP clients approached during 6-month recruitment period. Assessed using count data of individuals failing screen.
Proportion of Eligible Participants who Enroll	Week 1	Proportion of all eligible persons who enroll. Assessed using count data of individuals consented.
Mean Number of Intervention Sessions Attended	Up to Week 12	Mean number of teletherapy sessions attended by enrolled participants. Assessed using count data of session attendance.
Proportion of Study Visits Completed by Enrolled Participants	Week 12	Proportion of study visits completed by enrolled participants. Assessed using count data of study visit attendance.
Proportion of Participants With at Least one SSP-based Coach Encounter	Week 12	Proportion of participants who have attended at least one teletherapy sessions and have had at least one SSP-based coach encounters.
Participant-rated Client Satisfaction Questionnaire Score	Week 12	8-item, participant-rated assessment of satisfaction with intervention. Total score is the sum of responses and ranges from 8 to 32. Higher scores indicate greater client satisfaction and treatment acceptability.
Therapist & Coach-Rated Feasibility of Intervention Measure Score	Week 12	Four-item, clinician-rated assessment of the feasibility of the intervention. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated feasibility.
Therapist & Coach-Rated Acceptability of Intervention Measure Score	Week 12	Four-item, clinician-rated assessment of the acceptability of the intervention. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated acceptability.
Therapist & Coach-Rated Intervention Appropriateness Measure Score	Week 12	Four-item, clinician-rated assessment of whether the intervention is appropriate for the setting and target population. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated appropriateness.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in PCL-5 Total Score	Baseline and Week 12	The PCL-5 has 20 items assessing PTSD symptom severity. Total scores range from 0-80 with higher scores indicating more severe PTSD symptoms. The score at baseline will be subtracted from the score at week 12.
Changes from baseline in self-reported past 30-day use of prescribed MOUD	Baseline and Week 12	Number of self-reported days in the past 30 days in which prescribed MOUD was taken. The number at baseline will be subtracted from the number at week 12.
Changes from baseline in self-reported days of nonprescribed opioids	Baseline and Week 12	Number of self-reported days of nonprescribed opioids in past 30 days using the Drug Use section of the Addiction Severity Index. The number at baseline will be subtracted from the number at 12 weeks.

Trial Locations

Locations (1)

OnPoint; 🇺🇸 New York, New York, United States