A Preliminary Study on the Effectiveness of a Psychosocial Treatment Program (Emotion Regulation Program) for Substance Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility: Program Completion (Retention) Rate
研究概览
简要总结
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.
详细描述
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 Emotion Regulation 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 Emotion Regulation Program to inpatients with substance use disorders.
- Secondary objective: to examine preliminary changes in craving (VAS-C), motivation to change (URICA-DO), difficulties in emotion regulation (DERS-SF), self-compassion (K-SCS), depression (PHQ-9), 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, and group therapy, and draws on emotion-regulation and self-compassion skills. Session themes are: (1) understanding emotions and following the body's signals; (2) emotion regulation strategies I: grounding oneself through the senses when shaken; (3) emotion regulation strategies II: practicing choice rather than being swept away by emotion; (4) building a personal emotion-response scenario for moments of crisis; (5) facing the self-critical voice; (6) protecting oneself with warmth in difficult moments; (7) noticing and savoring positive moments; and (8) organizing a personal emotion-regulation routine to sustain going forward.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 and >= 2 DSM-5 criteria
排除标准
- •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
研究组 & 干预措施
Emotion Regulation Program
All participants receive the Emotion Regulation 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, and group therapy, and draws on emotion-regulation and self-compassion skills, covering emotional awareness, sensory grounding, choosing responses over reactions, crisis coping, self-compassion, savoring positive emotions, and a personalized emotion-regulation routine.
干预措施: Emotion Regulation Program (Behavioral)
结局指标
主要结局
Feasibility: Program Completion (Retention) Rate
时间窗: From enrollment through the end of the 8-session intervention (approximately 4 weeks)
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.
Change in Craving (VAS-C)
时间窗: 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
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.
次要结局
- 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 Difficulties in Emotion Regulation (DERS-SF)(Baseline, post-intervention (within 1 week), 1 month and 3 months after completion)
- Change in Self-Compassion (K-SCS)(Baseline, post-intervention (within 1 week), 1 month and 3 months after completion)
- Change in Depression (PHQ-9)(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)
研究者
Hae Kook Lee
Professor
The Catholic University of Korea