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Implementing DBT in Short-Term SUD-treatment

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07693439
Enrollment
82
Registered
2026-07-09
Start date
2026-07-01
Completion date
2027-04-30
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dialectical Behavior Therapy, Emotion Management Skills, Substance Abuse Disorder

Keywords

Dialectial behavior therapy, Inpatiens substance use treatments, SUD, Mixed methods

Brief summary

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).

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.

Interventions

BEHAVIORALDBT-informed milieu therapy

Implementation of DBT-informed milieu therapy, including staff training and integration of DBT-informed principles and skills into daily inpatient treatment.

BEHAVIORALTreatment as usual

Standard short-term inpatient SUD treatment including milieu therapy, individual counseling, group-based interventions and pharmacological treatment according to routine clinical practice.

Sponsors

Helse Møre og Romsdal HF
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Mixed method including a quantitative prospective repeated measures study and a qualitative study of staffs' perceptions. The study has a prospective, sequential A-B design with repeated measurements adapted for pilot and implementation purposes. Phase A (TAU): Patients receive ordinary treatment as usual in a short-term inpatient ward. Phase B (DBT-SUD): Patients receive a structured DBT-informed milieu therapeutic approach integrated into ordinary inpatient treatment. Phase B is implemented after staff have completed planned training in DBT-SUD and associated milieu therapeutic principles. The training period is not included in the data collection, and data collection in Phase B occurs only after the DBT-informed approach has been established in clinical practice.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Fidelity to DBT-informed milieu therapy implementationDuring 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.

Secondary

MeasureTime frameDescription
Emotion regulation (DERS 16 total score)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.
DBT coping skills (DBT-WCCL)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.
Borderline symptom List (BSL-23)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.
Alcohol use (AUDIT total score)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
Drug use (DUDIT total score)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.

Countries

Norway

Contacts

CONTACTMerethe Wenaas, PhD
Merethe.wenaas@helse-mr.no+4797580780
PRINCIPAL_INVESTIGATORMerethe Wenaas, PhD

Helse Møre og Romsdal HF

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026