First Step Program for Substance Use Disorders

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:

1. Primary objective: to evaluate the real-world feasibility of delivering the First Step Program to inpatients with substance use disorders. 2. 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. 3. 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.

Assessment schedule: Baseline assessment occurs within one week before the program. Craving is assessed immediately before and after each session, along with a stage-of-change rating, session satisfaction, and a treatment fidelity self-assessment. Post-intervention assessment occurs within one week after the program, followed by a focus group interview. Follow-up assessments are conducted at 1 month and 3 months after program completion.

Statistical analysis: Feasibility will be summarized using recruitment, retention, session attendance, and assessment completion rates. Change in continuous outcomes over time (pre, post, follow-up) will be analyzed using paired t-tests and linear mixed models; binary outcomes will be analyzed using McNemar's test and, where covariate adjustment for repeated measures is needed, generalized estimating equations. Missing data judged to be MCAR/MAR will be handled via maximum likelihood estimation within linear mixed models or multiple imputation, with sensitivity analyses. The main analysis is based on the full analysis set, with the per-protocol set as a supportive analysis. Qualitative focus group data will be transcribed and analyzed using thematic analysis (Braun \& Clarke, 2006) by at least two independent coders.

• Change in Craving (VAS-C) [Срок оценки: 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) [Срок оценки: Baseline, post-intervention (within 1 week), 1 month and 3 months after completion]
• Change in Social Support (2-Way Social Support Scale) [Срок оценки: Baseline, post-intervention (within 1 week), 1 month and 3 months after completion]
• Change in Drug Use and Treatment Service Utilization [Срок оценки: Baseline, post-intervention (within 1 week), 1 month and 3 months after completion]
• Program Acceptability (Focus Group Interview) [Срок оценки: Within 1 week after program completion]