First Step Program for Substance Use Disorders

A Preliminary Study on the Effectiveness of a Psychosocial Treatment Program (First Step Program) for Substance Use Disorders

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Substance Use Disorder (SUD)
• Intervention / Treatment: Behavioral: First Step Program

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:

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hae Kook Lee, MD, PhD; Phone Number: +82-31-820-3050; Email: policyhklee@gmail.com
• Study Contact Backup: Name: Hae-Ryoung Chun, PhD; Phone Number: +82-10-6567-7833; Email: mamimihae@catholic.ac.kr

Study Locations

• South Korea
  • Daegu, South Korea
    • Daegu Daedong Hospital
    • Contact: Do-Hoon Kwon, MD, PhD; Phone Number: +82-53-663-1634; Email: dohoonkwon@hotmail.com
  • Incheon, South Korea
    • Incheon Chamsarang Hospital
    • Contact: Younghoon Chon, MD, PhD; Phone Number: +82-32-571-9111; Email: 8542231@daum.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: First Step Program; Four 50-minute group sessions delivered twice weekly over approximately two weeks. Session 1: treatment, choice, and personal values. Session 2: understanding the function of substance use and exploring alternative behaviors. Session 3: addressing ambivalence and recovery-supporting relationships. Session 4: charting a recovery direction and declaring a personal recovery plan. Core techniques are motivational interviewing, acceptance and commitment therapy, and group therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Program Completion (Retention) Rate	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.	From enrollment through the end of the 4-session intervention (approximately 2 weeks)
Change in Motivation to Change (URICA-DO)	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).	Baseline (within 1 week before program), post-intervention (within 1 week after program), 1 month and 3 months after program completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Craving (VAS-C)	Craving measured by the Visual Analog Scale for Craving (VAS-C), ranging from 0 to 100 mm (0 = no craving, 100 = constant craving); higher scores indicate greater craving (worse outcome).	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)	Engagement in valued living measured by the Engaged Living Scale (ELS), a 16-item scale rated from 1 to 5 (total range 16 to 80); higher scores indicate greater engagement in valued living (better outcome).	Baseline, post-intervention (within 1 week), 1 month and 3 months after completion
Change in Social Support (2-Way Social Support Scale)	Perceived social support measured by the 2-Way Social Support Scale (2-Way SSS), a 19-item scale rated from 1 to 5 (total range 19 to 95) covering received and provided support; higher scores indicate greater social support (better outcome).	Baseline, post-intervention (within 1 week), 1 month and 3 months after completion
Change in Drug Use and Treatment Service Utilization	Self-reported drug use history and treatment service utilization assessed via a structured 1:1 interview. Recall window is the past 30 days at most time points and the past 2 months at the 3-month follow-up.	Baseline, post-intervention (within 1 week), 1 month and 3 months after completion
Program Acceptability (Focus Group Interview)	Acceptability and subjective experience of the program explored through a focus group interview using a semi-structured guide, analyzed by thematic analysis.	Within 1 week after program completion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stage of Change Rating per Session	Readiness for treatment engagement rated on a visual analog scale from 0 to 100 mm (0 = participating reluctantly, 100 = ready to participate actively); higher scores indicate greater readiness (better outcome).	Immediately after each of the 4 sessions (over approximately 2 weeks)
Session Satisfaction	Participant-rated helpfulness of each session on a visual analog scale from 0 to 100 mm (0 = not helpful at all, 100 = very helpful); higher scores indicate greater satisfaction (better outcome).	Immediately after each of the 4 sessions
Treatment Fidelity (Adherence Rate)	Therapist self-assessed treatment fidelity comprising structural fidelity and clinical-process fidelity items (yes/no), summarized as an adherence rate per session and per therapist.	Immediately after each of the 4 sessions

Collaborators and Investigators

• Sponsor: The Catholic University of Korea
• Investigators: Principal Investigator: Hae Kook Lee, MD, PhD, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Estimated): June 22, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Acceptance and Commitment Therapy; Craving; Group therapy; Psychosocial intervention; Motivation to change
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: UC26FIDI0017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a small, single-group pilot study involving sensitive data from patients with substance use disorders. Given the limited sample size and re-identification risk, individual participant data will not be shared. Only de-identified, aggregated results will be reported.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No