Emotion Regulation Program for Substance Use Disorders
A Preliminary Study on the Effectiveness of a Psychosocial Treatment Program (Emotion Regulation Program) for Substance Use Disorders
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.
調査の概要
詳細な説明
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.
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Hae Kook Lee, MD, PhD
- 電話番号：+82-31-820-3050
- メール：policyhklee@gmail.com
研究連絡先のバックアップ
- 名前：Hae-Ryoung Chun, PhD
- 電話番号：+82-10-6567-7833
- メール：mamimihae@catholic.ac.kr
研究場所
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Daegu、韓国
- Daegu Daedong Hospital
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コンタクト：
- Do-Hoon Kwon, MD, PhD
- 電話番号：+82-53-663-1634
- メール：dohoonkwon@hotmail.com
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Incheon、韓国
- Incheon Chamsarang Hospital
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コンタクト：
- Younghoon Chon, MD, PhD
- 電話番号：+82-32-571-9111
- メール：8542231@daum.net
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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Eight 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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility: Program Completion (Retention) Rate
時間枠：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 Emotion Regulation 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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Change in Craving (VAS-C)
時間枠：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.
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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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Drug Use and Treatment Service Utilization
時間枠：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)
時間枠：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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Change in Difficulties in Emotion Regulation (DERS-SF)
時間枠：Baseline, post-intervention (within 1 week), 1 month and 3 months after completion
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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).
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Baseline, post-intervention (within 1 week), 1 month and 3 months after completion
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Change in Self-Compassion (K-SCS)
時間枠：Baseline, post-intervention (within 1 week), 1 month and 3 months after completion
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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).
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Baseline, post-intervention (within 1 week), 1 month and 3 months after completion
|
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Change in Depression (PHQ-9)
時間枠：Baseline, post-intervention (within 1 week), 1 month and 3 months after completion
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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).
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Baseline, post-intervention (within 1 week), 1 month and 3 months after completion
|
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Program Acceptability (Focus Group Interview)
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Session Usefulness and Therapeutic Alliance
時間枠：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)
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Hae Kook Lee、The Catholic University of Korea
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- UC26FIDI0066
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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