Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations
概览
- 阶段
- 不适用
- 干预措施
- Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT)
- 疾病 / 适应症
- Polysubstance Abuse
- 发起方
- NYU Langone Health
- 入组人数
- 76
- 试验地点
- 3
- 主要终点
- Proportion of Eligible Participants who Enroll
- 状态
- 进行中（未招募）
- 最后更新
- 上个月
概览
简要总结
During this 36-month R34 trial, eight study phases are proposed to adapt an evidence-based post traumatic stress disorder (PTSD) intervention (STAIR-NT) and layer it into a methadone maintenance treatment (MMT) program (START Treatment and Recovery centers) in New York City for use among individuals engaged in stimulant-opioid polysubstance use. The study aims to adapt STAIR-NT to a massed treatment schedule. Once an adapted protocol is complete, it will be tested for feasibility, acceptability, and short-term polysubstance and PTSD symptomology outcomes in a pilot randomized control trial (RCT) of 80 participants. Participants who screen eligible and consent will be randomized 1:1 to the adapted STAIR-NT intervention or treatment as usual (TAU) using randomization blocks of two and two and four via a computer-generated randomization sequence. Participants assigned to the intervention will receive the adapted massed delivery of STAIR-NT by trained counselors.
研究者
入排标准
入选标准
- •must be 18 years or older,
- •be a patient at the START clinic receiving methadone for treatment of opioid use disorder,
- •self-report 10+ days of co-use of cocaine and illicit opioids in the past 30-days,
- •meet the criteria for stimulant use disorder (cocaine type; mild, moderate or severe) and a score of 3≥ on the PC-PTSD-5.
排除标准
- •cognitive impairment that would interfere with their ability to understand study participation as assessed by the researcher,
- •does not speak/understand English at a conversational level,
- •plans to leave the START clinic in the next 60 days,
- •patients who missed methadone doses (inactive) for 30 days or more, or
- •having received clinical care from the interventionist(s) in the past 30 days
研究组 & 干预措施
Adapted STAIR-NT Intervention
干预措施: Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT)
Treatment as Usual (TAU)
干预措施: Treatment as Usual
结局指标
主要结局
Proportion of Eligible Participants who Enroll
时间窗: Baseline
.Proportion of all eligible persons who enroll. Assessed using count data of individuals consented.
Clinician-Rated Feasibility of Acceptability of Intervention Measure (AIM) Score
时间窗: Month 3
4-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.
Number of Substances Used based on Chart Abstraction of Toxicology Results
时间窗: Month 3
PTSD Checklist for DSM-5 (PCL-5) Score
时间窗: Month 3
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Each item is rated on a scale from 0-4. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; higher scores indicate greater severity of PTSD.
Number of Substances Used based on ASI Self-Report
时间窗: Month 3
Measured using the Addiction Severity Index (ASI) questionnaire, a self-report assessment to gauge the severity of a person's substance abuse.
Negative Mood Regulation Scale Score
时间窗: Month 3
30-item assessment of individuals' beliefs and expectations regarding their ability to regulate their negative mood and emotions. Each item is rated on a 5-point Likert scale ranging from 1 (not at all effective) to 5 (extremely effective). The total score ranges from 30-150; higher scores indicate more effective negative mood regulation.
Inventory of Interpersonal Problems Score
时间窗: Month 3
A 127-item, self-report inventory that asks participants to rate a variety of interpersonal problems that may cause distress. The items are divided into two groups: (1) interpersonal inadequacies or inhibitions (78 items), (2) excesses or compulsions (49 items). Participants rate each item on a scale from 0 to 4 on how much difficulty/distress they feel regarding the item. The total score is calculated by adding the item responses; lower scores indicate less difficulty/distress.
Proportion of Eligible Participants
时间窗: Baseline
Proportion of persons eligible to enroll in the study of all possible MMT patients approached. Assessed using count data of individuals failing screen.
Number of Intervention Sessions Completed
时间窗: Up to Month 3
Number of Days of Co-Use of Cocaine and Illicit Opioids
时间窗: Month 3
Measured using the Addiction Severity Index (ASI) questionnaire.
Clinician-Rated Feasibility of Intervention Measure (FIM) Score
时间窗: Month 3
4-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.
Number of Substances Used based on Urine Drug Screen
时间窗: Month 3