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

N/AActive Not RecruitingNCT06872164

The City College of New York11 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Posttraumatic Stress Disorder (PTSD)Opioid Use Disorder

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

Time frame: Baseline

Proportion of Eligible Participants who Enroll

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

Time frame: Week 1

Mean Number of Intervention Sessions Attended

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Week 12

Secondary Outcomes

Change From Baseline in PCL-5 Total Score

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.

Time frame: Baseline and Week 12

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

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.

Time frame: Baseline and Week 12

Changes from baseline in self-reported days of nonprescribed opioids

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.

Time frame: Baseline and Week 12

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes