Substance Abuse DisorderNCT07693439
Implementing DBT in Short-Term SUD-treatment
A study testing DBT-informed milieu therapy and Treatment as usual in people with Substance Abuse Disorder and Dialectical Behavior Therapy, run by Helse Møre og Romsdal HF at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse Disorder, Dialectical Behavior Therapy, Emotion Management Skills
- What is being tested?
- DBT-informed milieu therapy and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jul 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unable to understand study information. Unable to provide informed consent. Severe cognitive impairment or other conditions preventing meaningful participation in study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
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.
- Being tested
- DBT-informed milieu therapy, Treatment as usual
- Keywords
- Dialectial behavior therapy, Inpatiens substance use treatments, SUD, Mixed methods
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT-informed milieu therapyBehavioural
Implementation of DBT-informed milieu therapy, including staff training and integration of DBT-informed principles and skills into daily inpatient treatment.
Treatment as usualBehavioural
Standard short-term inpatient SUD treatment including milieu therapy, individual counseling, group-based interventions and pharmacological treatment according to routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| DBT-informed milieu therapy | Experimental | Patients receiving short-term inpatient SUD treatment after implementation of DBT-informed milieu therapy. Receives: 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. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the 12 week implementation period.
Secondary outcomes (5)
Emotion regulation (DERS 16 total score)
Total score on the Difficulties in Emotion Regulation Scale-16. Higher scores indicate greater difficulties in emotion regulation.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline and Discharge (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Jul 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Substance Abuse DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Møre og Romsdal HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Merethe Wenaas, PhD, Principal investigator, Helse Møre og Romsdal HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693439
- Sponsor's protocol ID
- 1002796
- Status last verified
- Sep 2026
- First submitted
- 26 Jun 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 21035130Dimeff, 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 10957822Visted 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 37347324Vigfusdottir, 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 at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Implementation of DBT-informed Milieu Therapy in Short-term Inpatient Substance Abuse Treatment
- ClinicalTrials.gov ID
- NCT07693439
- Acronym / sponsor ID
- 1002796
- Keywords
- Dialectial behavior therapy, Inpatiens substance use treatments, SUD, Mixed methods
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Helse Møre og Romsdal HFOther government
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| DBT-informed milieu therapy | Experimental | Behavioral: DBT-informed milieu therapyPatients receiving short-term inpatient SUD treatment after implementation of DBT-informed milieu therapy. |
| treatment as usual | Active comparator | Behavioral: Treatment as usualPatients receiving standard short-term inpatient SUD treatment before implementation of DBT-informed milieu therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Unable to understand study information. Unable to provide informed consent. Severe cognitive impairment or other conditions preventing meaningful participation in study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBT-informed milieu therapyImplementation of DBT-informed milieu therapy, including staff training and integration of DBT-informed principles and skills into daily inpatient treatment. | Behavioural | DBT-informed milieu therapy |
| Treatment as usualStandard short-term inpatient SUD treatment including milieu therapy, individual counseling, group-based interventions and pharmacological treatment according to routine clinical practice. | Behavioural | treatment as usual |
Primary outcome
Fidelity to DBT-informed milieu therapy implementation
Time frame: 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.
5 secondary outcomes
Emotion regulation (DERS 16 total score)
Time frame: Baseline, 6. weeks and discharge (12 weeks)
DBT coping skills (DBT-WCCL)
Time frame: Baseline, 6 weeks and Discharge (12 weeks)
Borderline symptom List (BSL-23)
Time frame: Baseline, 6 Weeks and Discharge (12 weeks)
Alcohol use (AUDIT total score)
Time frame: Baseline and Discharge (12 weeks)
Drug use (DUDIT total score)
Time frame: Baseline and Discharge (12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 21035130Leon 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.
- BackgroundDimeff, 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: PubMed 10957822Bohus 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.
- Background: PubMed 37347324Visted 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.
- BackgroundVigfusdottir, 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 dataSharing planned: 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.
Related trials for Substance Abuse Disorder
Active, not recruitingObservational study
Cannabis Use and Outcomes in Black and White Patients With Cancer
Cancer
Not yet recruitingPhase 1/2
Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder
Treatment Resistant Depression, Substance Use Disorders
RecruitingObservational study
Treatment Outcomes Under a Standardized Treatment Protocol in Patients Suffered Substance Abuse Related Voiding Dysfunction
Voiding Dysfunction, Substance Abuse
Active, not recruiting
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
Opioid Dependence, Substance Abuse Disorders
Enrolling by invitationObservational study
Cannabis, Neuroinflammation, and Suicidal Ideation: A Supplemental Brain Imaging Study
PTSD, Suicidal Thoughts and Behaviors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Merethe Wenaas, PhD principal investigator
Helse Møre og Romsdal HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT-informed milieu therapy and Treatment as usual in people with Substance Abuse Disorder and Dialectical Behavior Therapy, run by Helse Møre og Romsdal HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fidelity to DBT-informed milieu therapy implementation (time frame: During the 12 week implementation period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07693439, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.