ClinicalTrials.gg
Enrolling by invitationNCT07693439Updated Sep 25, 2026

Implementing DBT in Short-Term SUD-treatment

An interventional study of DBT-informed milieu therapy and Treatment as usual in Substance Abuse Disorder, Dialectical Behavior Therapy and Emotion Management Skills, sponsored by Helse Møre og Romsdal HF. Enrolling by invitation at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Helse Møre og Romsdal HF · Not applicable, Interventional, and Treatment

Updated Sep 25, 2026Now Enrolling by invitationGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 41 studies in Substance-Related Disorders with a site in Norway — 8 open to participants now, 15 under way, none of them phase 3. Substance-Related Disorders · Norway.

Planned enrollment
20th of 28
82 · median 138
Started
2026
with 1 other
No phase
23 of 41
7 open now
Primary completion
2027-03
later than 10 of 14 live
Registered
41st of 41
by date
Lead sponsor
1 of 41
Helse Møre og Romsdal HF

Among the 41 studies in Substance-Related Disorders with a site in Norway, this one is the 20th largest by planned enrollment of the 28 interventional ones that give a count, is one of 2 that started in 2026, is one of 23 with no phase, reaches primary completion later than 10 of the 14 other live ones, and was the 41st registered.

Substance-Related Disorders

2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.

Browse Substance-Related Disorders studies →

Open to participants now

8 of the 41 studies in Substance-Related Disorders with a site in Norway are open now. Recruiting first, the newest first:

2 more — sign in →

All 8 open studies →

A study can be open while its sites in Norway have not opened yet or have stopped. Only those recruiting at a site in Norway →

Who these studies take

Of the 266 Substance-Related Disorders studies recruiting now, 130 (49%) set no upper age limit and 118 (44%) stop at 75 or younger; 56 take children under 18; 89 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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).

Read the 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.

03

Conditions studied

  • Substance Abuse Disorder
  • Dialectical Behavior Therapy
  • Emotion Management Skills

Keywords

  • Dialectial behavior therapy
  • Inpatiens substance use treatments
  • SUD
  • Mixed methods
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
82 participants (estimated)

Study arms

  • Experimental
    DBT-informed milieu therapy

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

    Behavioral: DBT-informed milieu therapy

  • Active comparator
    treatment as usual

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

    Behavioral: Treatment as usual

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.

06

What researchers measure

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.

    Time frame: During the 12 week implementation period.

Secondary outcomes

  1. Emotion regulation (DERS 16 total score)

    Total score on the Difficulties in Emotion Regulation Scale-16. Higher scores indicate greater difficulties in emotion regulation.

    Time frame: Baseline, 6. weeks and discharge (12 weeks)

  2. 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.

    Time frame: Baseline, 6 weeks and Discharge (12 weeks)

  3. Borderline symptom List (BSL-23)

    Total score on the Borderline Symptom List-23 (BSL-23). Higher scores indicate greater severity of borderline-related symptoms.

    Time frame: Baseline, 6 Weeks and Discharge (12 weeks)

  4. 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

    Time frame: Baseline and Discharge (12 weeks)

  5. 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.

    Time frame: Baseline and Discharge (12 weeks)

07

Study locations

1 site
08

References and documents

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. PubMed 21035130 ↗
  • 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. PubMed 10957822 ↗
  • 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. PubMed 37347324 ↗
  • 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

Individual participant data

Plan to share: No — 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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Mar 2027, 8 months after the start.

Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's planned 8 months is below that.

Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 26, 2026
First posted
Jul 9, 2026
StartActual
Jul 1, 2026
Primary completionEst.
Mar 30, 2027
CompletionEst.
Apr 30, 2027
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Enrolling by invitation
changed Sep 25, 2026
Contact
No study contact listed any more: removed M•••@helse-mr.no · •••0780
Sep 25, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Helse Møre og Romsdal HF · Ålesund, NorwayContact removed M•••@helse-mr.no · •••0780
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Not yet recruiting→Enrolling by invitation
    Contact No study contact listed any more: removed M•••@helse-mr.no · •••0780
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Helse Møre og Romsdal HF · Ålesund, NorwayContact removed M•••@helse-mr.no · •••0780
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07693439
Lead sponsor
Helse Møre og Romsdal HF
Responsible party
Sponsor
First posted
Jul 9, 2026
Start date
Jul 1, 2026
Primary completion
Mar 30, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Merethe Wenaas, PhD
principal investigator · Helse Møre og Romsdal HF

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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