Craving Management 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 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.

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

Craving Management and Alternative Behavior Enhancement Program
Behavioral
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.

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Craving Management and Alternative Behavior Enhancement ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

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

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 (range -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 completion

Change in Behavioral Activation (K-BADS-SF)

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).

Time frame

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

Change in Mindfulness (K-MMAS)

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).

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

Session Usefulness and Therapeutic Alliance

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).

Time frame

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

Treatment Fidelity (Adherence Rate)

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.

Time frame

Immediately after each of the 8 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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