- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07698808
Craving Management Program for Substance Use Disorders
A Preliminary Study on the Effectiveness of a Psychosocial Treatment Program (Craving Management and Alternative Behavior Enhancement Program) for Substance Use Disorders
This study examines whether a newly developed eight-session psychosocial treatment program, called the Craving Management and Alternative Behavior Enhancement 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, behavioral activation, and group activities, and is delivered twice a week over about four weeks (eight 50-minute sessions). About 20 adults will take part at two psychiatric hospitals.
Participants complete brief questionnaires and a short interview about their craving, motivation to change, behavioral activation, positive and negative affect, mindfulness, and drug use history 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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
Background: Substance use among the Korean population has increased rapidly, with spread into adolescents and people in their twenties. 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 Craving Management and Alternative Behavior Enhancement 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 Craving Management and Alternative Behavior Enhancement Program to inpatients with substance use disorders.
- Secondary objective: to examine preliminary changes in craving (VAS-C), motivation to change (URICA-DO), behavioral activation (K-BADS-SF), positive and negative affect (K-PANAS-SF), mindfulness (K-MMAS), 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 program consists of eight 50-minute group sessions delivered twice weekly over approximately four weeks. It integrates motivational interviewing, acceptance and commitment therapy, behavioral activation, and group therapy. Session themes are: (1) how craving arises; (2) craving regulation strategies I: the pause between impulse and action; (3) craving regulation strategies II: from automatic reactions to chosen responses; (4) anticipating high-risk situations and building a personal coping card; (5) identifying alternative behaviors that fit one's own life; (6) building small but reliable 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 session satisfaction and a therapist 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 repeated-measures analysis of variance and linear mixed models; where covariate adjustment for repeated measures is needed, generalized estimating equations will be used. Analyses adjust for sociodemographic covariates and indication variables, or use stratified comparison. 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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Hae Kook Lee, MD, PhD
- Telefonszám: +82-31-820-3050
- E-mail: policyhklee@gmail.com
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Hae-Ryoung Chun, PhD
- Telefonszám: +82-10-6567-7833
- E-mail: mamimihae@catholic.ac.kr
Tanulmányi helyek
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-
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Daegu, Dél -Korea
- Daegu Daedong Hospital
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Kapcsolatba lépni:
- Do-Hoon Kwon, MD, PhD
- Telefonszám: +82-53-663-1634
- E-mail: dohoonkwon@hotmail.com
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Incheon, Dél -Korea
- Incheon Chamsarang Hospital
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Kapcsolatba lépni:
- Younghoon Chon, MD, PhD
- Telefonszám: +82-32-571-9111
- E-mail: 8542231@daum.net
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
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, craving reported as present on the VAS-C craving screening (i.e., "yes"), 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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: Craving Management and Alternative Behavior Enhancement Program
All participants receive the Craving Management and Alternative Behavior Enhancement Program, an eight-session group-based psychosocial treatment delivered twice weekly (50 minutes per session) over approximately four weeks.
The program integrates motivational interviewing, acceptance and commitment therapy, behavioral activation, and group therapy, covering craving awareness, craving-regulation strategies, high-risk situation coping, alternative behaviors, routine building, gratitude, and a personalized recovery plan.
|
Eight 50-minute group sessions delivered twice weekly over approximately four weeks.
Session 1: how craving arises.
Session 2: craving regulation strategies I (the pause between impulse and action).
Session 3: craving regulation strategies II (from automatic reactions to chosen responses).
Session 4: anticipating high-risk situations and building a personal coping card.
Session 5: identifying alternative behaviors that fit one's own life.
Session 6: building small but reliable routines.
Session 7: noticing positive moments and cultivating gratitude.
Session 8: creating a personal recovery practice manual.
Core techniques are motivational interviewing, acceptance and commitment therapy, behavioral activation, and group therapy.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change in Craving (VAS-C)
Időkeret: Immediately before and immediately after each of the 8 sessions (over approximately 4 weeks); baseline (within 1 week before the program); within 1 week post-intervention; 1 month and 3 months after completion
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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).
Change from baseline is assessed at post-intervention and follow-up.
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Immediately before and immediately after each of the 8 sessions (over approximately 4 weeks); baseline (within 1 week before the program); within 1 week post-intervention; 1 month and 3 months after completion
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Feasibility: Program Completion (Retention) Rate
Időkeret: From enrollment through the end of the 8-session intervention (approximately 4 weeks)
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Proportion of enrolled participants who complete all eight sessions of the Craving Management and Alternative Behavior Enhancement Program.
Feasibility is further characterized by recruitment rate, session attendance, and assessment completion rates.
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From enrollment through the end of the 8-session intervention (approximately 4 weeks)
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in Drug Use and Treatment Service Utilization
Időkeret: Baseline, post-intervention (within 1 week), 1 month and 3 months after completion
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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.
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Baseline, post-intervention (within 1 week), 1 month and 3 months after completion
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Change in Motivation to Change (URICA-DO)
Időkeret: Baseline (within 1 week before program), post-intervention (within 1 week after program), 1 month and 3 months after completion
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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 (range -2 to 14); higher scores indicate greater readiness to change (better outcome).
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Baseline (within 1 week before program), post-intervention (within 1 week after program), 1 month and 3 months after completion
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Program Acceptability (Focus Group Interview)
Időkeret: Within 1 week after program completion
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Acceptability and subjective experience of the program explored through a focus group interview using a semi-structured guide, analyzed by thematic analysis (Braun & Clarke, 2006).
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Within 1 week after program completion
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Change in Behavioral Activation (K-BADS-SF)
Időkeret: Baseline, post-intervention (within 1 week), 1 month and 3 months after completion
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Behavioral activation measured by the Korean version of the Behavioral Activation for Depression Scale-Short Form (K-BADS-SF), a 9-item scale rated from 0 to 6, with avoidance/rumination items reverse-scored; higher total scores indicate greater behavioral activation (better outcome).
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Baseline, post-intervention (within 1 week), 1 month and 3 months after completion
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Change in Mindfulness (K-MMAS)
Időkeret: Baseline, post-intervention (within 1 week), 1 month and 3 months after completion
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Mindful attention and awareness measured by the Korean version of the Mindful Attention Awareness Scale (K-MMAS), a 15-item scale rated from 1 to 7 (total range 15 to 105); higher scores indicate greater mindful attention and awareness (better outcome).
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Baseline, post-intervention (within 1 week), 1 month and 3 months after completion
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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Session Usefulness and Therapeutic Alliance
Időkeret: Immediately after each of the 8 sessions (over approximately 4 weeks)
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Participant-rated helpfulness of each session and therapeutic alliance on a visual analog scale from 0 to 10 (0 = not helpful at all, 10 = very helpful); higher scores indicate greater perceived usefulness and alliance (better outcome).
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Immediately after each of the 8 sessions (over approximately 4 weeks)
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Treatment Fidelity (Adherence Rate)
Időkeret: Immediately after each of the 8 sessions
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Therapist self-assessed treatment fidelity comprising common structural-fidelity items, session-specific core-practice items, and overall clinical-process fidelity items (yes/no), summarized as an adherence rate per session and per therapist.
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Immediately after each of the 8 sessions
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Hae Kook Lee, MD, PhD, study principal investigator
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- UC26FIDI0065
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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