- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07693439
Implementing DBT in Short-Term SUD-treatment
Pilot Study of Implementation of DBT-informed Milieu Therapy in Short-term Inpatient Substance Abuse Treatment
The main objective of the study is to provide new knowledge about the implementation of DBT-informed environmental therapy in short-term substance use disorder (SUD) inpatient treatment. The study will examine which organizational and clinical conditions promote or inhibit implementation in clinical practice by elucidating how the implementation is experienced by staff (including experiences with structure, skill focus and environmental therapeutic principles) related to DBT-informed environmental therapy, DBT-SUD skill groups and patients' perceived satisfaction and utility.
A secondary and exploratory aim is to examine preliminary trends in clinical measures in patients over time, including changes in symptom burden and reported use of DBT skills throughout the course of treatment. The study further seeks, at a descriptive and hypothesis-generating level, to explore patterns in patient-reported conditions related to substance abuse, emotion regulation, and other clinical burden. The sample will consist of up to 70 adult patients and 12 staff. One half of the patients will receive ordinary short-term inpatient treatment, while the other half will receive DBT informs milieu therapy after the approach has been established in clinical practice without being implemented. All patients will complete questionnaires upon admission (baseline), week 6 and upon discharge (week 12).
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
This pilot implementation study evaluates the introduction of DBT-informed milieu therapy in a short-term inpatient substance use disorder (SUD) treatment unit. The study aims to investigate the feasibility, acceptability, and fidelity of implementing DBT-informed milieu therapy in routine clinical practice, as well as to explore preliminary trends in patient-reported clinical outcomes.
The study uses a sequential A-B design. During Phase A, patients receive treatment as usual (TAU), consisting of standard short-term inpatient SUD treatment. During Phase B, DBT-informed milieu therapy is implemented as part of routine care following staff training and integration of DBT-informed principles and skills into daily clinical practice.
Implementation outcomes are assessed at the unit level and include measures of fidelity, feasibility, acceptability, and adherence to planned implementation activities. Data sources include implementation records, staff questionnaires, and qualitative interviews with staff members involved in the implementation process.
Patient-reported clinical outcomes are collected to explore changes during treatment and to generate hypotheses for future studies. Outcomes include emotion regulation, borderline symptom severity, DBT-related coping skills, alcohol use, and drug use. Data are collected at admission (baseline), week 6, and discharge when applicable.
The study is conducted in a multidisciplinary specialized substance use disorder treatment service. Adult patients admitted to the participating short-term inpatient unit are recruited consecutively during the study period. The study is intended to provide knowledge about factors that facilitate or hinder implementation of DBT-informed milieu therapy and to inform future larger-scale evaluations.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Merethe Wenaas, PhD
- Telefonní číslo: +4797580780
- E-mail: Merethe.wenaas@helse-mr.no
Studijní místa
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More and Romsdal
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Ålesund, More and Romsdal, Norsko, 6018
- Helse Møre og Romsdal HF
-
Kontakt:
- Merethe Wenaas, PhD
- Telefonní číslo: +4797580780
- E-mail: Merethe.wenaas@helse-mr.no
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria
Adults aged 18 years or older. Admitted to the participating short-term inpatient substance use disorder treatment unit during the study period.
Able and willing to provide written informed consent.
Exclusion Criteria
Unable to understand study information. Unable to provide informed consent. Severe cognitive impairment or other conditions preventing meaningful participation in study procedures.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: DBT-informed milieu therapy
Patients receiving short-term inpatient SUD treatment after implementation of DBT-informed milieu therapy.
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Implementation of DBT-informed milieu therapy, including staff training and integration of DBT-informed principles and skills into daily inpatient treatment.
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Aktivní komparátor: treatment as usual
Patients receiving standard short-term inpatient SUD treatment before implementation of DBT-informed milieu therapy.
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Standard short-term inpatient SUD treatment including milieu therapy, individual counseling, group-based interventions and pharmacological treatment according to routine clinical practice.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Fidelity to DBT-informed milieu therapy implementation
Časové okno: During the 12 week implementation period.
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Degree of implementation of DBT-informed milieu therapy at the unit level, assessed through documentation of staff training, implementation activities and adherence to planned DBT-informed practices, and feedback from staff and patients.Fidelity assessed through implementation records, staff questionnaires and qualitative staff interviews.
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During the 12 week implementation period.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Emotion regulation (DERS 16 total score)
Časové okno: Baseline, 6. weeks and discharge (12 weeks)
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Total score on the Difficulties in Emotion Regulation Scale-16.
Higher scores indicate greater difficulties in emotion regulation.
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Baseline, 6. weeks and discharge (12 weeks)
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Borderline symptom List (BSL-23)
Časové okno: Baseline, 6 Weeks and Discharge (12 weeks)
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Total score on the Borderline Symptom List-23 (BSL-23).
Higher scores indicate greater severity of borderline-related symptoms.
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Baseline, 6 Weeks and Discharge (12 weeks)
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DBT coping skills (DBT-WCCL)
Časové okno: Baseline, 6 weeks and Discharge (12 weeks)
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Use of coping skills assessed with the DBT Ways of Coping Checklist (DBT-WCCL).
The instrument measures the use of DBT-consistent coping strategies during treatment.
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Baseline, 6 weeks and Discharge (12 weeks)
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Alcohol use (AUDIT total score)
Časové okno: Baseline and Discharge (12 weeks)
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Alcohol use and alcohol-related problems assessed using the Alcohol Use Disorders Identification Test (AUDIT).
Higher scores indicate greater alcohol-related risk and problems
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Baseline and Discharge (12 weeks)
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Drug use (DUDIT total score)
Časové okno: Baseline and Discharge (12 weeks)
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Drug use and drug-related problems assessed using the Drug Use Disorders Identification Test (DUDIT).
Higher scores indicate greater drug-related risk and problems.
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Baseline and Discharge (12 weeks)
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Merethe Wenaas, PhD, Helse Møre og Romsdal HF
Publikace a užitečné odkazy
Obecné publikace
- Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626-9. doi: 10.1016/j.jpsychires.2010.10.008. Epub 2010 Oct 28.
- Visted E, Solbakken OA, Maeland S, Fadnes LT, Bjerrum LB, Nordhus IH, Flo-Groeneboom E. Validation of a brief version of the Difficulties in Emotion Regulation Scale (DERS-16) with an older Norwegian population. Eur J Ageing. 2023 Jun 22;20(1):26. doi: 10.1007/s10433-023-00775-w.
- Dimeff, L., Rizvi, S. L., Brown, M., & Linehan, M. M. (2000). Dialectical behavior therapy for substance abuse: A pilot application to methamphetamine-dependent women with borderline personality disorder. Cognitive and Behavioral Practice, 7(4), 457-468. https://doi.org/10.1016/S1077-7229(00)80057-7
- Bohus M, Haaf B, Stiglmayr C, Pohl U, Bohme R, Linehan M. Evaluation of inpatient dialectical-behavioral therapy for borderline personality disorder--a prospective study. Behav Res Ther. 2000 Sep;38(9):875-87. doi: 10.1016/s0005-7967(99)00103-5.
- Vigfusdottir, J., Breivik, E., Mork, E., et al. (2026). Combined treatment of PTSD and emotional dysregulation among inpatients with substance use disorder: A feasibility study. International Journal of Mental Health and Addiction
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
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