First Step Program for Substance Use Disorders

ConditionSubstance Use Disorder (SUD)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age19-65

SponsorThe Catholic University of Korea

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: First Step ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Catholic University of Korea

Lead sponsor

Source ClinicalTrials.gov

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