An interventional study of First Step Program in Substance Use Disorder (SUD), sponsored by The Catholic University of Korea. Not yet recruiting at 2 sites in South Korea. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by The Catholic University of Korea · Not applicable, Interventional, and Treatment
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.
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:
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.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 20 is below the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →The Catholic University of Korea is the lead sponsor of 155 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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).
Time frame: Baseline (within 1 week before program), post-intervention (within 1 week after program), 1 month and 3 months after program completion
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Within 1 week after program completion
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).
Time frame: 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).
Time frame: 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.
Time frame: Immediately after each of the 4 sessions
Plan to share: No — 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.
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Dec 2026, 6 months later.
Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's planned 6 months is below that.
Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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