Opioid Use Disorder, Posttraumatic Stress Disorder (PTSD)
Conditions
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
Interventions
BEHAVIORALCognitive Processing Therapy
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.
Sponsors
The City College of New York
National Institute on Drug Abuse (NIDA)
Albert Einstein College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Eligible Participants | 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. |
| Proportion of Eligible Participants who Enroll | Week 1 | Proportion of all eligible persons who enroll. Assessed using count data of individuals consented. |
| Mean Number of Intervention Sessions Attended | Up 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 Participants | Week 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 Encounter | Week 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 Score | 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. |
| Therapist & Coach-Rated Feasibility of Intervention Measure Score | 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. |
| Therapist & Coach-Rated Acceptability of Intervention Measure Score | 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. |
| Therapist & Coach-Rated Intervention Appropriateness Measure Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in PCL-5 Total Score | 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. |
| Changes from baseline in self-reported past 30-day use of prescribed MOUD | 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. |
| Changes from baseline in self-reported days of nonprescribed opioids | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTeresa Lopez-Castro, PhD
The City College of New York, CUNY
PRINCIPAL_INVESTIGATORAaron D Fox, MD
Albert Einstein College of Medicine
Outcome results
None listed