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Implementing DBT in Short-Term SUD-treatment

10. juli 2026 oppdatert av: Helse Møre og Romsdal HF

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).

Studieoversikt

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

82

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • More and Romsdal
      • Ålesund, More and Romsdal, Norge, 6018

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: DBT-informed milieu therapy
Patients receiving short-term inpatient SUD treatment after implementation of 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.
Aktiv komparator: treatment as usual
Patients receiving standard short-term inpatient SUD treatment before implementation of DBT-informed milieu therapy.
Standard short-term inpatient SUD treatment including milieu therapy, individual counseling, group-based interventions and pharmacological treatment according to routine clinical practice.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fidelity to DBT-informed milieu therapy implementation
Tidsramme: During the 12 week implementation period.
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.
During the 12 week implementation period.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Emotion regulation (DERS 16 total score)
Tidsramme: Baseline, 6. weeks and discharge (12 weeks)
Total score on the Difficulties in Emotion Regulation Scale-16. Higher scores indicate greater difficulties in emotion regulation.
Baseline, 6. weeks and discharge (12 weeks)
Borderline symptom List (BSL-23)
Tidsramme: Baseline, 6 Weeks and Discharge (12 weeks)
Total score on the Borderline Symptom List-23 (BSL-23). Higher scores indicate greater severity of borderline-related symptoms.
Baseline, 6 Weeks and Discharge (12 weeks)
DBT coping skills (DBT-WCCL)
Tidsramme: Baseline, 6 weeks and Discharge (12 weeks)
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.
Baseline, 6 weeks and Discharge (12 weeks)
Alcohol use (AUDIT total score)
Tidsramme: Baseline and Discharge (12 weeks)
Alcohol use and alcohol-related problems assessed using the Alcohol Use Disorders Identification Test (AUDIT). Higher scores indicate greater alcohol-related risk and problems
Baseline and Discharge (12 weeks)
Drug use (DUDIT total score)
Tidsramme: Baseline and Discharge (12 weeks)
Drug use and drug-related problems assessed using the Drug Use Disorders Identification Test (DUDIT). Higher scores indicate greater drug-related risk and problems.
Baseline and Discharge (12 weeks)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Merethe Wenaas, PhD, Helse Møre og Romsdal HF

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

30. mars 2027

Studiet fullført (Antatt)

30. april 2027

Datoer for studieregistrering

Først innsendt

26. juni 2026

Først innsendt som oppfylte QC-kriteriene

3. juli 2026

Først lagt ut (Faktiske)

9. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

It has not yet been determined whether de-identified individual participant data will be made available. Any future data sharing will be subject to applicable ethical approvals, institutional policies, data protection regulations, and participant consent.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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