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

Onsite PTSD Treatment to Improve MOUD Outcomes: Open Pilot Trial of Stakeholder-engaged Adapted Cognitive Processing Therapy

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

Study Overview

• Status: Active, not recruiting
• Conditions: Opioid Use Disorder; Posttraumatic Stress Disorder (PTSD)
• Intervention / Treatment: Behavioral: Cognitive Processing Therapy

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10035
      • OnPoint

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adapted Cognitive Processing Therapy; 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.	Behavioral: Cognitive Processing Therapy; Cognitive Processing Therapy (CPT) is an evidence-based psychotherapy for PTSD that provides education and teaches skills to challenge the trauma-related beliefs that maintain PTSD symptoms. In this study, CPT has been adapted to include content on the relationship between substance use and PTSD and a focus on harm reduction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Eligible Participants	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.	Baseline
Proportion of Eligible Participants who Enroll	Proportion of all eligible persons who enroll. Assessed using count data of individuals consented.	Week 1
Mean Number of Intervention Sessions Attended	Mean number of teletherapy sessions attended by enrolled participants. Assessed using count data of session attendance.	Up to Week 12
Proportion of Study Visits Completed by Enrolled Participants	Proportion of study visits completed by enrolled participants. Assessed using count data of study visit attendance.	Week 12
Proportion of Participants With at Least one SSP-based Coach Encounter	Proportion of participants who have attended at least one teletherapy sessions and have had at least one SSP-based coach encounters.	Week 12
Participant-rated Client Satisfaction Questionnaire Score	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.	Week 12
Therapist & Coach-Rated Feasibility of Intervention Measure Score	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.	Week 12
Therapist & Coach-Rated Acceptability of Intervention Measure Score	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.	Week 12
Therapist & Coach-Rated Intervention Appropriateness Measure Score	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.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in PCL-5 Total Score	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.	Baseline and Week 12
Changes from baseline in self-reported past 30-day use of prescribed MOUD	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.	Baseline and Week 12
Changes from baseline in self-reported days of nonprescribed opioids	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.	Baseline and Week 12

Collaborators and Investigators

• Sponsor: The City College of New York
• Collaborators: National Institute on Drug Abuse (NIDA); Albert Einstein College of Medicine
• Investigators: Principal Investigator: Teresa Lopez-Castro, PhD, The City College of New York, CUNY; Principal Investigator: Aaron D Fox, MD, Albert Einstein College Of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 12, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Stress Disorders, Traumatic; Opioid-Related Disorders; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: IRB# 2025-16601; R61DA059032 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected, deidentified individual patient data from enrolled participants of the open trial will be shared. Final datasets will include self-reported psychosocial, demographic, and behavioral data from interviews, and urine toxicology data.
• IPD Sharing Time Frame: Data will be available upon completion of the multi-site trial (2029).
• IPD Sharing Access Criteria: Given that deidentified data will contain sensitive information, it will be archived at the National Addiction & HIV Data Archive Program NAHDAP, a controlled-access repository. Data will be findable via NAHDAP's persistent unique identifiers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No