A Preliminary Study on the Effectiveness of a Psychosocial Treatment Program (First Step Program) for Substance Use Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Feasibility: Program Completion (Retention) Rate
Study Overview
Brief Summary
This study examines whether a newly developed four-session psychosocial treatment program, called the First Step Program, can be delivered in real-world hospital settings to people receiving inpatient care for substance use disorders in Korea, and whether it shows early signs of benefit. The program combines motivational interviewing, acceptance and commitment therapy, and group activities, and is delivered twice a week over about two weeks (four 50-minute sessions). About 20 adults will take part at two psychiatric hospitals.
Participants complete brief questionnaires and a short interview about their motivation to change, craving, engagement in valued living, and social support before the program, immediately before and after each session, within one week after the program ends, and again at 1 month and 3 months after completion. After the program, some participants also join a small group discussion (focus group interview) to share their experience of the program.
Because this is a small, single-group preliminary (pilot) study without a comparison group, its primary purpose is to assess feasibility, that is, whether the program and the assessment approach work well enough, and to obtain preliminary effect and variability estimates to inform the design of a future large-scale randomized controlled trial.
Detailed Description
Background: Substance use among the Korean population has increased rapidly, yet standardized, evidence-based psychosocial treatment programs and a corresponding clinician training and certification system are not well established in Korea. Evidence-based psychosocial interventions such as cognitive behavioral therapy, motivational interviewing, community reinforcement approaches, and 12-step facilitation are widely used as standard care in other countries, but comparable, locally validated programs are scarce in Korea. To address this gap, a Korean psychosocial treatment program (the First Step Program) was developed, and this preliminary study evaluates its feasibility and preliminary effectiveness.
Objectives:
- Primary objective: to evaluate the real-world feasibility of delivering the First Step Program to inpatients with substance use disorders.
- Secondary objective: to examine preliminary changes in motivation to change (URICA-DO), craving (VAS-C), engaged living (Engaged Living Scale), social support (2-Way Social Support Scale), and drug use history and treatment service utilization, and to assess whether these measures are suitable for a future comparative trial.
- Tertiary objective: to explore participants' subjective experience and the acceptability of the program through a focus group interview, in order to refine the treatment manual and operational protocol for a future randomized controlled trial.
Design and setting: This is a single-arm, pre-post study with follow-up, without a control group. A total of 20 participants (10 per site) will be enrolled at two psychiatric hospitals that provide care to a large proportion of patients with drug use disorders in Korea (Incheon Chamsarang Hospital and Daegu Daedong Hospital). Study planning, rater training, informed consent storage, data management, and statistical analysis are coordinated centrally by the Catholic University of Korea. The two participating sites do not have their own IRB and are reviewed under the Uijeongbu St. Mary's Hospital IRB.
Intervention: The First Step Program consists of four 50-minute group sessions delivered twice weekly. The program integrates motivational interviewing, acceptance and commitment therapy, and group therapy. Session themes are: (1) treatment, choice, and personal values; (2) understanding the function of substance use and imagining alternative paths; (3) ambivalence and recovery-supporting relationships; and (4) charting a recovery direction and declaring a personal recovery plan.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 19 to 65 years who can understand the study purpose and procedures and provide written informed consent
- •Currently hospitalized (inpatient)
- •Able to communicate and complete questionnaires in Korean
- •Physically able to participate in program activities
- •Has completed detoxification treatment
- •Meets indication thresholds: DAST-10 score >= 2, URICA-DO precontemplation or contemplation stage, and >= 2 DSM-5 criteria
Exclusion Criteria
- •Cognitive impairment that precludes communication
- •Physical conditions that preclude program participation (e.g., musculoskeletal disorder, severe cardiopulmonary disease)
- •Acute psychotic symptoms or risk of self-harm or harm to others
- •At risk of disrupting group activities such that focus group participation is not feasible
- •Individuals who are inmates or incarcerated at screening are not enrolled; participants who become incarcerated after enrollment are withdrawn
Arms & Interventions
First Step Program
All participants receive the First Step Program, a four-session group-based psychosocial treatment delivered twice weekly (50 minutes per session) over approximately two weeks. The program integrates motivational interviewing, acceptance and commitment therapy, and group therapy, covering values clarification, functional analysis of substance use, ambivalence and recovery-supporting relationships, and a personalized recovery plan.
Intervention: First Step Program (Behavioral)
Outcomes
Primary Outcomes
Feasibility: Program Completion (Retention) Rate
Time Frame: From enrollment through the end of the 4-session intervention (approximately 2 weeks)
Proportion of enrolled participants who complete all four sessions of the First Step Program. Feasibility is further characterized by recruitment rate, session attendance, and assessment completion rates.
Change in Motivation to Change (URICA-DO)
Time Frame: Baseline (within 1 week before program), post-intervention (within 1 week after program), 1 month and 3 months after program completion
Motivation to change (readiness) measured by the Korean version of the University of Rhode Island Change Assessment for Drug Offenders (URICA-DO), a 24-item scale rated from 1 (strongly disagree) to 5 (strongly agree) with four subscales (Precontemplation, Contemplation, Action, Maintenance). A Readiness to Change score is computed as the sum of the mean Contemplation, Action, and Maintenance subscale scores minus the mean Precontemplation subscale score, yielding a range of -2 to 14; higher scores indicate greater readiness to change (better outcome).
Secondary Outcomes
- Change in Craving (VAS-C)(Immediately before and immediately after each of the 4 sessions (over approximately 2 weeks); baseline (within 1 week before the program); within 1 week post-intervention; 1 month post-intervention; 3 months post-intervention)
- Change in Engaged Living (Engaged Living Scale, ELS)(Baseline, post-intervention (within 1 week), 1 month and 3 months after completion)
- Change in Social Support (2-Way Social Support Scale)(Baseline, post-intervention (within 1 week), 1 month and 3 months after completion)
- Change in Drug Use and Treatment Service Utilization(Baseline, post-intervention (within 1 week), 1 month and 3 months after completion)
- Program Acceptability (Focus Group Interview)(Within 1 week after program completion)
Investigators
Hae Kook Lee
Professor
The Catholic University of Korea