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

The City College of New York

Status: Enrolling

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

Treatments: Behavioral: Cognitive Processing Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06872164

IRB# 2025-16601

R61DA059032 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Adapted Cognitive Processing Therapy

Experimental group

Description:

Participants will receive 4-18 sessions of telehealth-delivered Cognitive Processing Therapy (CPT) adapted for people who use syringe services programs. Participants will attend the 50-minute CPT sessions in a private space within the syringe services program.

Treatment:

Behavioral: Cognitive Processing Therapy