Onsite PTSD Treatment to Improve MOUD Outcomes: Open Pilot Trial of Stakeholder-engaged Adapted Cognitive Processing Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Proportion of Eligible Participants
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Adapted Cognitive Processing Therapy
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.
干预措施: Cognitive Processing Therapy (Behavioral)
结局指标
主要结局
Proportion of Eligible Participants
时间窗: 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
时间窗: Week 1
Proportion of all eligible persons who enroll. Assessed using count data of individuals consented.
Mean Number of Intervention Sessions Attended
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change From Baseline in PCL-5 Total Score(Baseline and Week 12)
- Changes from baseline in self-reported past 30-day use of prescribed MOUD(Baseline and Week 12)
- Changes from baseline in self-reported days of nonprescribed opioids(Baseline and Week 12)
研究者
Teresa Lopez-Castro
Associate Professor
The City College of New York