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

NCT06872164 | Recruiting

• 2 other identifiers: IRB# 2025-16601R61DA059032
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Posttraumatic Stress Disorder (PTSD); Opioid Use Disorder

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (3)

• Change From Baseline in PCL-5 Total Score

  Baseline and Week 12

• Changes from baseline in self-reported past 30-day use of prescribed MOUD

  Baseline and Week 12

• Changes from baseline in self-reported days of nonprescribed opioids

  Baseline and Week 12

Study Arms (1)

Adapted Cognitive Processing Therapy

EXPERIMENTAL

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

Interventions

Cognitive Processing Therapy BEHAVIORAL

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.

Adapted Cognitive Processing Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• Albert Einstein College of Medicine: collaborator
• The City College of New York: lead

Study Sites (1)

OnPoint

New York, New York, 10035, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Teresa Lopez-Castro, PhD

  The City College of New York, CUNY

  PRINCIPAL INVESTIGATOR

• Aaron D Fox, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Lopez-Castro, PhD

CONTACT

646-745-7123; tlopezcastro@ccny.cuny.edu

Aaron D Fox, MD

CONTACT

718-920-7173; adfox@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 12, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available upon completion of the multi-site trial (2029).
• 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.

Locations

US (1)