Clinical trial NCT06872164: Open Pilot Trial of Adapted Cognitive Processing Therapy for Comorbid PTSD and Opioid Use Disorder
Official title: Onsite PTSD Treatment to Improve MOUD Outcomes: Open Pilot Trial of Stakeholder-engaged Adapted Cognitive Processing Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder (PTSD)
Opioid Use Disorder
Lead sponsor: The City College of New York
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Albert Einstein College of Medicine
First posted: 2025-03-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: Proportion of Eligible Participants
timeFrame: Baseline
measure: Proportion of Eligible Participants who Enroll
timeFrame: Week 1
measure: Mean Number of Intervention Sessions Attended
timeFrame: Up to Week 12
measure: Proportion of Study Visits Completed by Enrolled Participants
timeFrame: Week 12
measure: Proportion of Participants With at Least one SSP-based Coach Encounter
timeFrame: Week 12
measure: Participant-rated Client Satisfaction Questionnaire Score
timeFrame: Week 12
measure: Therapist & Coach-Rated Feasibility of Intervention Measure Score
timeFrame: Week 12
measure: Therapist & Coach-Rated Acceptability of Intervention Measure Score
timeFrame: Week 12
measure: Therapist & Coach-Rated Intervention Appropriateness Measure Score
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in PCL-5 Total Score
timeFrame: Baseline and Week 12
measure: Changes from baseline in self-reported past 30-day use of prescribed MOUD
timeFrame: Baseline and Week 12
measure: Changes from baseline in self-reported days of nonprescribed opioids
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: OnPoint
state: New York
Study officials:
affiliation: The City College of New York, CUNY
name: Teresa Lopez-Castro, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Einstein College of Medicine
name: Aaron D Fox, MD
role: PRINCIPAL_INVESTIGATOR
References: