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First Step Program for Substance Use Disorders

NCT07658963 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2026-06-22
Last updated
2026-06-22

Condition(s) studied

Substance Use Disorder (SUD)

Investigational drug(s) / intervention(s)

First Step Program

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.

Study 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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
65 Years
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

Primary outcome measure(s)

  • Feasibility: Program Completion (Retention) Rate — 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) — 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).

Trial sites (2)

FacilityCityRegionStatus
Daegu Daedong Hospital Daegu South Korea
Incheon Chamsarang Hospital Incheon South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07658963 on ClinicalTrials.gov ↗ ← All trials in South Korea