NCT06872164

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

Active, Not Recruiting
NAAges 18+InterventionalTreatment
The City College of New York
~11 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Cognitive Processing Therapy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Eligible Participants
Measured over Baseline
+8 more outcomes measured
Posttraumatic Stress Disorder (PTSD)
Opioid Use Disorder
1 sites across 1 states
New York1
  • Teresa Lopez-Castro, PhD · PRINCIPAL_INVESTIGATOR · The City College of New York, CUNY
  • Aaron D Fox, MD · PRINCIPAL_INVESTIGATOR · Albert Einstein College of Medicine

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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).
  • Proportion of Eligible ParticipantsBaseline

    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.

  • Proportion of Eligible Participants who EnrollWeek 1

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

  • Mean Number of Intervention Sessions AttendedUp to Week 12

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

  • Proportion of Study Visits Completed by Enrolled ParticipantsWeek 12

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

  • Proportion of Participants With at Least one SSP-based Coach EncounterWeek 12

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

  • Participant-rated Client Satisfaction Questionnaire ScoreWeek 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.

  • Therapist & Coach-Rated Feasibility of Intervention Measure ScoreWeek 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.

  • Therapist & Coach-Rated Acceptability of Intervention Measure ScoreWeek 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.

  • Therapist & Coach-Rated Intervention Appropriateness Measure ScoreWeek 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.