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).

Study Overview

• Status: Not yet recruiting
• Conditions: Substance Abuse Disorder; Dialectical Behavior Therapy; Emotion Management Skills
• Intervention / Treatment: Behavioral: DBT-informed milieu therapy; Behavioral: Treatment as usual

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Merethe Wenaas, PhD; Phone Number: +4797580780; Email: Merethe.wenaas@helse-mr.no

Study Locations

• Norway
  • More and Romsdal
    • Ålesund, More and Romsdal, Norway, 6018
      • Helse Møre og Romsdal HF
      • Contact: Merethe Wenaas, PhD; Phone Number: +4797580780; Email: Merethe.wenaas@helse-mr.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DBT-informed milieu therapy; Patients receiving short-term inpatient SUD treatment after implementation of DBT-informed milieu therapy.	Behavioral: 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.
Active Comparator: treatment as usual; Patients receiving standard short-term inpatient SUD treatment before implementation of DBT-informed milieu therapy.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fidelity to DBT-informed milieu therapy implementation	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotion regulation (DERS 16 total score)	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)	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)	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)	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)	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)

Collaborators and Investigators

• Sponsor: Helse Møre og Romsdal HF
• Investigators: Principal Investigator: Merethe Wenaas, PhD, Helse Møre og Romsdal HF

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: July 3, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Mixed methods; SUD; Dialectial behavior therapy; Inpatiens substance use treatments
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Therapeutics
• Other Study ID Numbers: 1002796

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No