Substance Use Disorder (SUD)NCT07658963
First Step Program for Substance Use Disorders
A study testing First Step Program in people with Substance Use Disorder (SUD), run by The Catholic University of Korea at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Substance Use Disorder (SUD)
- What is being tested?
- First Step Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 22 Jun 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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are inmates or incarcerated at screening are not enrolled; participants who become incarcerated after enrollment are withdrawn
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites
Daegu Daedong Hospital
Daegu
Do-Hoon Kwon, MD, PhD, +82-53-663-1634, dohoonkwon@hotmail.com
Incheon Chamsarang Hospital
Incheon
Younghoon Chon, MD, PhD, +82-32-571-9111, 8542231@daum.net
About this study
Official title: 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.
Read the 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:
- Primary objective: to evaluate the real-world feasibility of delivering the First Step Program to inpatients with substance use disorders.
- 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.
- 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.
- Conditions
- Substance Use Disorder (SUD)
- Being tested
- First Step Program
- Keywords
- Psychosocial intervention, Craving, Group therapy, Acceptance and Commitment Therapy, Motivation to change
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First Step ProgramBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: First Step Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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)
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Within 1 week after program completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start22 Jun 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm pre-post study with follow-up; all participants receive the First Step Program.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hae Kook Lee, The Catholic University of Korea
- Investigators
- Hae Kook Lee, MD, PhD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658963
- Sponsor's protocol ID
- UC26FIDI0017
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study on the Effectiveness of a Psychosocial Treatment Program (First Step Program) for Substance Use Disorders
- ClinicalTrials.gov ID
- NCT07658963
- Acronym / sponsor ID
- UC26FIDI0017
- Conditions
- Substance Use Disorder (SUD)
- Keywords
- Psychosocial intervention, Craving, Group therapy, Acceptance and Commitment Therapy, Motivation to change
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 22 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Primary objective: to evaluate the real-world feasibility of delivering the First Step Program to inpatients with substance use disorders.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm pre-post study with follow-up; all participants receive the First Step Program.
| Arm | Type | Receives |
|---|---|---|
| First Step Program | Experimental | Behavioral: First Step ProgramAll 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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| First Step ProgramFour 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. | Behavioural | First Step Program |
Primary outcome
Feasibility: Program Completion (Retention) Rate
Time frame: 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)
Time frame: 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).
5 secondary outcomes
Change in Craving (VAS-C)
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)
Time frame: Baseline, post-intervention (within 1 week), 1 month and 3 months after completion
Change in Social Support (2-Way Social Support Scale)
Time frame: Baseline, post-intervention (within 1 week), 1 month and 3 months after completion
Change in Drug Use and Treatment Service Utilization
Time frame: Baseline, post-intervention (within 1 week), 1 month and 3 months after completion
Program Acceptability (Focus Group Interview)
Time frame: Within 1 week after program completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hae Kook Lee, MD, PhD principal investigator
The Catholic University of Korea
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First Step Program in people with Substance Use Disorder (SUD), run by The Catholic University of Korea at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hae Kook Lee, MD, PhD (+82-31-820-3050, policyhklee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Program Completion (Retention) Rate (time frame: From enrollment through the end of the 4-session intervention (approximately 2 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.