Implementing DBT in Short-Term SUD-treatment

Официальное название

Pilot Study of Implementation of DBT-informed Milieu Therapy in Short-term Inpatient Substance Abuse Treatment

Обзор

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).

Подробное описание

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.

Вмешательства

• Поведенческое DBT-informed milieu therapy
  Implementation of DBT-informed milieu therapy, including staff training and integration of DBT-informed principles and skills into daily inpatient treatment.
• Поведенческое Treatment as usual
  Standard short-term inpatient SUD treatment including milieu therapy, individual counseling, group-based interventions and pharmacological treatment according to routine clinical practice.

Первичные конечные точки

• Fidelity to DBT-informed milieu therapy implementation [Срок оценки: During the 12 week implementation period.]

Вторичные конечные точки (5)

• Emotion regulation (DERS 16 total score) [Срок оценки: Baseline, 6. weeks and discharge (12 weeks)]
• DBT coping skills (DBT-WCCL) [Срок оценки: Baseline, 6 weeks and Discharge (12 weeks)]
• Borderline symptom List (BSL-23) [Срок оценки: Baseline, 6 Weeks and Discharge (12 weeks)]
• Alcohol use (AUDIT total score) [Срок оценки: Baseline and Discharge (12 weeks)]
• Drug use (DUDIT total score) [Срок оценки: Baseline and Discharge (12 weeks)]

Критерии участия

Критерии включения

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.

Критерии исключения

Unable to understand study information. Unable to provide informed consent. Severe cognitive impairment or other conditions preventing meaningful participation in study procedures.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Норвегия · 1 центр

• Helse Møre og Romsdal HF — Ålesund

Публикации

• 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. PMID 21035130
• 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. PMID 10957822
• 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. PMID 37347324
• 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

Идентификаторы

NCT: NCT07693439 · 1002796

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗