Adapted Cognitive Processing Therapy for PTSD in people with Opioid Use Disorder delivered by telehealth at syringe services programs
Onsite PTSD Treatment to Improve MOUD Outcomes: Open Pilot Trial of Stakeholder-engaged Adapted Cognitive Processing Therapy
This pilot will test whether adapted Cognitive Processing Therapy delivered by telehealth at syringe services programs can help adults with both PTSD and opioid use disorder reduce PTSD symptoms and stay on medications like buprenorphine or methadone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The City College of New York Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06872164 on ClinicalTrials.gov |
What this trial studies
This open pilot delivers an adapted form of Cognitive Processing Therapy (CPT) by telehealth to clients who attend syringe services programs (SSPs). Participants receive 4–18 tele-CPT sessions at the SSP, complete between-session practice supported by SSP-based coaches, and meet with research staff monthly to complete surveys about PTSD symptoms, drug use, and mental health. Eligible participants are adults who attend SSPs regularly, meet DSM-5 criteria for opioid use disorder, are recently prescribed medication for opioid use disorder, and meet PTSD symptom criteria; those with high suicide risk, psychotic or bipolar disorders, or severe cognitive impairment are excluded. Sessions and some assessments are audio- or video-recorded for research and supervision purposes.
Who should consider this trial
Good fit: Adults (18+) who regularly attend a participating syringe services program, meet DSM-5 criteria for opioid use disorder, have been prescribed medication for opioid use disorder in the past 30 days, meet PTSD symptom criteria (PCL-5 ≥ 31), understand English, and can consent to recorded assessments and teletherapy.
Not a fit: People with current psychotic or bipolar disorders, high imminent suicide risk, severe cognitive impairment, those not attending the participating SSP, not on medication for opioid use disorder, or non-English speakers are unlikely to be eligible or benefit from this pilot.
Why it matters
Potential benefit: If successful, this approach could reduce PTSD symptoms and improve retention on medications for opioid use disorder, making trauma-focused care more accessible to SSP clients.
How similar studies have performed: Standard CPT is evidence-based for PTSD and has shown benefits in people with substance use disorders, but adapting CPT for telehealth delivery within syringe services programs for people with opioid use disorder is a novel pilot approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
New York, New York
- OnPoint — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Teresa Lopez-Castro, PhD — The City College of New York, CUNY
- Study coordinator: Teresa Lopez-Castro, PhD
- Email: tlopezcastro@ccny.cuny.edu
- Phone: 646-745-7123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.