Authors
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The Catholic University of Korea -More
Category
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Primary study
Registry of Trials»ClinicalTrials.gov
Year
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2026
Background: Substance use among the Korean population has increased rapidly, with spreadinto adolescents and people in their twenties. Yet standardized, evidence‐basedpsychosocial treatment programs and a corresponding clinician training and certificationsystem are not well established in Korea. Evidence‐based psychosocial interventions suchas cognitive behavioral therapy, motivational interviewing, community reinforcementapproaches, 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, aKorean psychosocial treatment program (the Craving Management and Alternative BehaviorEnhancement Program) was developed, and this preliminary study evaluates its feasibilityand preliminary effectiveness.Objectives: 1. Primary objective: to evaluate the real‐world feasibility of delivering the CravingManagement and Alternative Behavior Enhancement Program to inpatients with substanceuse disorders. 2. Secondary objective: to examine preliminary changes in craving (VAS‐C), motivationto change (URICA‐DO), behavioral activation (K‐BADS‐SF), positive and negativeaffect (K‐PANAS‐SF), mindfulness (K‐MMAS), and drug use history and treatmentservice utilization, and to assess whether these measures are suitable for a futurecomparative trial. 3. Tertiary objective: to explore participants' subjective experience and theacceptability of the program through a focus group interview, in order to refine thetreatment 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 acontrol group. A total of 20 participants (10 per site) will be enrolled at twopsychiatric hospitals that provide care to a large proportion of patients with drug usedisorders in Korea (Incheon Chamsarang Hospital and Daegu Daedong Hospital). Studyplanning, rater training, informed consent storage, data management, and statisticalanalysis are coordinated centrally by the Catholic University of Korea. The twoparticipating sites do not have their own IRB and are reviewed under the Uijeongbu St.Mary's Hospital IRB.Intervention: The program consists of eight 50‐minute group sessions delivered twiceweekly over approximately four weeks. It integrates motivational interviewing, acceptanceand commitment therapy, behavioral activation, and group therapy. Session themes are: (1)how craving arises; (2) craving regulation strategies I: the pause between impulse andaction; (3) craving regulation strategies II: from automatic reactions to chosenresponses; (4) anticipating high‐risk situations and building a personal coping card; (5)identifying alternative behaviors that fit one's own life; (6) building small butreliable routines; (7) noticing positive moments and cultivating gratitude; and (8)creating a personal recovery practice manual.Assessment schedule: Baseline assessment occurs within one week before the program.Craving is assessed immediately before and after each session, along with sessionsatisfaction and a therapist treatment‐fidelity self‐assessment. Post‐interventionassessment 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 overtime (pre, post, follow‐up) will be analyzed using repeated‐measures analysis of varianceand linear mixed models; where covariate adjustment for repeated measures is needed,generalized estimating equations will be used. Analyses adjust for sociodemographiccovariates and indication variables, or use stratified comparison. Missing data judged tobe MCAR/MAR will be handled via maximum likelihood estimation within linear mixed modelsor multiple imputation, with sensitivity analyses. The main analysis is based on the fullanalysis set, with the per‐protocol set as a supportive analysis. Qualitative focus groupdata will be transcribed and analyzed using thematic analysis (Braun & Clarke, 2006) byat least two independent coders.
Epistemonikos ID: 9623fc9fa767096f983061fe58cb174462c7e5c2
First added on: Jul 14, 2026