Implementing DBT in Short-Term SUD-treatment

NCT07693439 | Not Yet Recruiting

• 1 other identifier: 1002796
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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).

Conditions

Emotion Management Skills; Dialectical Behavior Therapy; Substance Abuse Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Emotion regulation (DERS 16 total score)

  Baseline, 6. weeks and discharge (12 weeks)

• DBT coping skills (DBT-WCCL)

  Baseline, 6 weeks and Discharge (12 weeks)

• Borderline symptom List (BSL-23)

  Baseline, 6 Weeks and Discharge (12 weeks)

• Alcohol use (AUDIT total score)

  Baseline and Discharge (12 weeks)

• Drug use (DUDIT total score)

  Baseline and Discharge (12 weeks)

Study Arms (2)

DBT-informed milieu therapy

EXPERIMENTAL

Patients receiving short-term inpatient SUD treatment after implementation of DBT-informed milieu therapy.

Behavioral: DBT-informed milieu therapy

treatment as usual

ACTIVE COMPARATOR

Patients receiving standard short-term inpatient SUD treatment before implementation of DBT-informed milieu therapy.

Behavioral: Treatment as usual

Interventions

DBT-informed milieu therapy BEHAVIORAL

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

DBT-informed milieu therapy

Treatment as usual BEHAVIORAL

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

treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Helse Møre og Romsdal HF: lead

Study Sites (1)

Helse Møre og Romsdal HF

Ålesund, More and Romsdal, 6018, Norway

Location

Related Publications (5)

• 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 BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Merethe Wenaas, PhD

  Helse Møre og Romsdal HF

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merethe Wenaas, PhD

CONTACT

+4797580780; Merethe.wenaas@helse-mr.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 9, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)