Emotion Regulation 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 Emotion Regulation 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 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, difficulties in emotion regulation, self-compassion, depression, 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 volunteersQualifiers
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
Emotion Regulation Program
BehavioralEight 50-minute group sessions delivered twice weekly over approximately four weeks. Session 1: understanding emotions and following the body's signals. Session 2: emotion regulation strategies I (grounding oneself through the senses when shaken). Session 3: emotion regulation strategies II (practicing choice rather than being swept away by emotion). Session 4: building a personal emotion-response scenario for moments of crisis. Session 5: facing the self-critical voice. Session 6: protecting oneself with warmth in difficult moments. Session 7: noticing and savoring positive moments. Session 8: organizing a personal emotion-regulation routine to sustain going forward. Core techniques are motivational interviewing, acceptance and commitment therapy, and group therapy, incorporating emotion-regulation and self-compassion skills.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Emotion Regulation ProgramExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility: Program Completion (Retention) Rate
Proportion of enrolled participants who complete all eight sessions of the Emotion Regulation 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)2
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 completionSecondary outcomes
1
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 completion2
Change in Difficulties in Emotion Regulation (DERS-SF)
Difficulties in emotion regulation measured by the Difficulties in Emotion Regulation Scale-Short Form (DERS-SF), an 18-item scale rated from 1 to 5 (total range 18 to 90); higher scores indicate greater difficulties in emotion regulation (worse outcome).
Time frame
Baseline, post-intervention (within 1 week), 1 month and 3 months after completion3
Change in Self-Compassion (K-SCS)
Self-compassion measured by the Korean version of the Self-Compassion Scale (K-SCS), a 26-item scale rated from 1 to 5; higher mean scores indicate greater self-compassion (better outcome).
Time frame
Baseline, post-intervention (within 1 week), 1 month and 3 months after completion4
Change in Depression (PHQ-9)
Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9), a 9-item scale rated from 0 to 3 (total range 0 to 27); higher scores indicate more severe depression (worse outcome).
Time frame
Baseline, post-intervention (within 1 week), 1 month and 3 months after completionOther outcomes
1
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)2
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 sessionsSponsors and contacts
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Source ClinicalTrials.gov
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