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OpenTrials
Active, Not Recruiting

NCT Number: NCT06872164

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Posttraumatic Stress Disorder (PTSD) Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid Use Disorder Opioid-Related Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OnPoint

New York, 10035, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Proportion of Eligible Participants

    Time frame: Baseline

    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.

  2. Proportion of Eligible Participants who Enroll

    Time frame: Week 1

    Proportion of all eligible persons who enroll. Assessed using count data of individuals consented.

  3. Mean Number of Intervention Sessions Attended

    Time frame: Up to Week 12

    Mean number of teletherapy sessions attended by enrolled participants. Assessed using count data of session attendance.

  4. Proportion of Study Visits Completed by Enrolled Participants

    Time frame: Week 12

    Proportion of study visits completed by enrolled participants. Assessed using count data of study visit attendance.

  5. Proportion of Participants With at Least one SSP-based Coach Encounter

    Time frame: Week 12

    Proportion of participants who have attended at least one teletherapy sessions and have had at least one SSP-based coach encounters.

  6. Participant-rated Client Satisfaction Questionnaire Score

    Time frame: Week 12

    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.

  7. Therapist & Coach-Rated Feasibility of Intervention Measure Score

    Time frame: Week 12

    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.

  8. Therapist & Coach-Rated Acceptability of Intervention Measure Score

    Time frame: Week 12

    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.

  9. Therapist & Coach-Rated Intervention Appropriateness Measure Score

    Time frame: Week 12

    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.

Secondary outcomes

  1. Change From Baseline in PCL-5 Total Score

    Time frame: Baseline and Week 12

    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.

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

    Time frame: Baseline and Week 12

    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.

  3. Changes from baseline in self-reported days of nonprescribed opioids

    Time frame: Baseline and Week 12

    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.

Sponsors and collaborators

Lead sponsor

The City College of New York

Other

Collaborators

  • Albert Einstein College of Medicine
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: OPTIMO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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