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| ID | Type | Description | Link |
|---|---|---|---|
| R61DA059032 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Albert Einstein College of Medicine | OTHER |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapted Cognitive Processing Therapy | Experimental | Participants will receive 4-18 sessions of telehealth-delivered Cognitive Processing Therapy (CPT) adapted for people who use syringe services programs. Participants will attend the 50-minute CPT sessions in a private space within the syringe services program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Proportion of Eligible Participants who Enroll | Proportion of all eligible persons who enroll. Assessed using count data of individuals consented. | Week 1 |
| Mean Number of Intervention Sessions Attended | Mean number of teletherapy sessions attended by enrolled participants. Assessed using count data of session attendance. | 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. | 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. | 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. | Week 12 |
| Therapist & Coach-Rated Feasibility of Intervention Measure Score |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 12 |
| Changes from baseline in self-reported past 30-day use of prescribed MOUD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teresa Lopez-Castro, PhD | The City College of New York, CUNY | Principal Investigator |
| Aaron D Fox, MD | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OnPoint | New York | New York | 10035 | United States |
All collected, deidentified individual patient data from enrolled participants of the open trial will be shared. Final datasets will include self-reported psychosocial, demographic, and behavioral data from interviews, and urine toxicology data.
Data will be available upon completion of the multi-site trial (2029).
Given that deidentified data will contain sensitive information, it will be archived at the National Addiction & HIV Data Archive Program NAHDAP, a controlled-access repository. Data will be findable via NAHDAP's persistent unique identifiers.
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
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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. |
| 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. | 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. | 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. |
| 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. | Baseline and Week 12 |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |