Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations

NYU Langone Health80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Polysubstance Abuse Posttraumatic Stress Disorder

Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT)BEHAVIORAL

Adapted version of evidence-based behavioral PTSD intervention.

Treatment as UsualBEHAVIORAL

Treatment as usual.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Locations (3)

Florida State University

Tallahassee, Florida, United States

RECRUITING

START Treatment and Recovery Centers

Brooklyn, New York, United States

RECRUITING

NYU Langone Health

New York, New York, United States

RECRUITING

Outcomes

Primary Outcomes

Proportion of Eligible Participants

Proportion of persons eligible to enroll in the study of all possible MMT patients approached. 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: Baseline

Number of Intervention Sessions Completed

Time frame: Up to Month 3

Clinician-Rated Feasibility of Intervention Measure (FIM) Score

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.

Time frame: Month 3

Clinician-Rated Feasibility of Acceptability of Intervention Measure (AIM) Score

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.

Time frame: Month 3

Number of Days of Co-Use of Cocaine and Illicit Opioids

Measured using the Addiction Severity Index (ASI) questionnaire.

Time frame: Month 3

Number of Substances Used based on ASI Self-Report

Measured using the Addiction Severity Index (ASI) questionnaire, a self-report assessment to gauge the severity of a person's substance abuse.

Time frame: Month 3

Number of Substances Used based on Urine Drug Screen

Time frame: Month 3

Number of Substances Used based on Chart Abstraction of Toxicology Results

Time frame: Month 3

PTSD Checklist for DSM-5 (PCL-5) Score

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.

Time frame: Month 3

Negative Mood Regulation Scale Score

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.

Time frame: Month 3

Inventory of Interpersonal Problems Score

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.

Time frame: Month 3