First Step Program for Substance Use Disorders

NCT07658963 | Not Yet Recruiting

• 1 other identifier: UC26FIDI0017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Substance Use Disorder (SUD)

Keywords

Psychosocial intervention; Craving; Group therapy; Acceptance and Commitment Therapy; Motivation to change

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Other Outcomes (3)

• Stage of Change Rating per Session

  Immediately after each of the 4 sessions (over approximately 2 weeks)

• Session Satisfaction

  Immediately after each of the 4 sessions

• Treatment Fidelity (Adherence Rate)

  Immediately after each of the 4 sessions

Study Arms (1)

First Step Program

EXPERIMENTAL

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

Interventions

First Step Program BEHAVIORAL

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.

First Step Program

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (2)

Daegu Daedong Hospital

Daegu, South Korea

Location

Incheon Chamsarang Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Hae Kook Lee, MD, PhD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hae Kook Lee, MD, PhD

CONTACT

+82-31-820-3050; policyhklee@gmail.com

Hae-Ryoung Chun, PhD

CONTACT

+82-10-6567-7833; mamimihae@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single-arm pre-post study with follow-up; all participants receive the First Step Program.

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 22, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)