- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Merethe Wenaas, PhD
- Telefonnummer: +4797580780
- E-mail: Merethe.wenaas@helse-mr.no
Studiesteder
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More and Romsdal
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Ålesund, More and Romsdal, Norge, 6018
- Helse Møre og Romsdal HF
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Kontakt:
- Merethe Wenaas, PhD
- Telefonnummer: +4797580780
- E-mail: Merethe.wenaas@helse-mr.no
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Aktiv komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Fidelity to DBT-informed milieu therapy implementation
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Emotion regulation (DERS 16 total score)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Merethe Wenaas, PhD, Helse Møre og Romsdal HF
Publikationer og nyttige links
Generelle publikationer
- 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
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1002796
Plan for individuelle deltagerdata (IPD)
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