NCT07698808

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Dec 2026

First Submitted

Initial submission to the registry

July 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 7, 2026

Last Update Submit

July 7, 2026

Conditions

Keywords

Psychosocial interventionCravingGroup therapyAcceptance and Commitment TherapyBehavioral activationMotivation to changeMindfulness

Outcome Measures

Primary Outcomes (2)

  • Feasibility: Program Completion (Retention) Rate

    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.

    From enrollment through the end of the 8-session intervention (approximately 4 weeks)

  • 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). Change from baseline is assessed at post-intervention and follow-up.

    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

Secondary Outcomes (5)

  • Change in Motivation to Change (URICA-DO)

    Baseline (within 1 week before program), post-intervention (within 1 week after program), 1 month and 3 months after completion

  • Change in Behavioral Activation (K-BADS-SF)

    Baseline, post-intervention (within 1 week), 1 month and 3 months after completion

  • Change in Mindfulness (K-MMAS)

    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 (2)

  • Session Usefulness and Therapeutic Alliance

    Immediately after each of the 8 sessions (over approximately 4 weeks)

  • Treatment Fidelity (Adherence Rate)

    Immediately after each of the 8 sessions

Study Arms (1)

Craving Management and Alternative Behavior Enhancement Program

EXPERIMENTAL

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.

Behavioral: Craving Management and Alternative Behavior Enhancement Program

Interventions

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.

Craving Management and Alternative Behavior Enhancement Program

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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, craving reported as present on the VAS-C craving screening (i.e., "yes"), 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 DisordersMental Disorders

Study Officials

  • Hae Kook Lee, MD, PhD

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hae Kook Lee, MD, PhD

CONTACT

Hae-Ryoung Chun, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-arm pre-post study with follow-up; all participants receive the Craving Management and Alternative Behavior Enhancement Program.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 13, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 13, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations