Addiction DisordersRégulAddictNCT07310511
Emotional Regulation & Addiction : Impact of In-person/Online Dialectic Behavior Therapy (DBT) vs Usual Treatment
A study testing Face-to-face DBT, Online DBT and Usual treatment in people with Addiction Disorders and Emotional Dysregulation, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
In psychiatry, psychotherapy is, along with pharmacotherapy, a major therapeutic intervention. It helps patients better understand their difficulties and informs them of possible solutions. It is systematically recommended in cases of psychiatric disorders, whether or not in combination with pharmacotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Addiction Disorders, Emotional Dysregulation
- What is being tested?
- Face-to-face DBT, Online DBT and Usual treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2026to Apr 2030
- 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
- Patients aged >18 years
- Patients affiliated with a social security health insurance plan
- Patients who are fluent in French, able to understand the objectives and risks associated with the research, and able to give dated and signed informed consent
- Patients with addictive disorders (substance and/or behavioral) presenting emotional dysregulation (DERS score >90) in the 3 months prior to the inclusion visit
- Patients whose treatment(s) for mood disorder regulation has been stable for 3 months
- No ongoing structured psychotherapy
Who cannot join
- Patients diagnosed with acute psychosis
- Patients with major neurocognitive disorders
- Patients with encephalopathy
- Patients in a period of exclusion (determined by a previous or ongoing study)
- Patients in an emergency/life-threatening situation
- Patients under legal protection
- Pregnancy (self-reported)/breastfeeding
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
In psychiatry, psychotherapy is, along with pharmacotherapy, a major therapeutic intervention. It helps patients better understand their difficulties and informs them of possible solutions. It is systematically recommended in cases of psychiatric disorders, whether or not in combination with pharmacotherapy.
With regard to addictive disorders in particular, few medications are available and psychotherapy is essential. Psychotherapy must be adapted to the severity of the patient's condition and the issues encountered. In cases of impaired emotional regulation, i.e., the ability to respond effectively to one's emotions, addictions become more difficult to stabilize without appropriate treatment. For patients with emotional regulation disorders, Dialectical Behavior Therapy (DBT) is the standard treatment. It consists of teaching acceptance and change skills in a dialectical manner to better regulate emotions.
Read more
Like other evidence-based psychotherapies, DBT is nevertheless not widely available. It requires therapists to have a high level of training and sufficient patient recruitment to form groups. Two solutions are being considered to improve the accessibility of DBT. To facilitate patient recruitment, transdiagnostic groups are useful because they bring together patients with different diagnoses. To help professionals deliver the therapy, digital tools such as pre-recorded videos or mobile applications have proven effective, particularly when guided by a therapist, but they also show some effectiveness without a therapist. Studies are still recent and few in number, and need to be replicated, particularly using a variety of digital tools.
The investigators want to evaluate the effectiveness of DBT on emotional regulation and impulsivity in addiction patients, in a transdiagnostic face-to-face format and in an online format using videos, compared to a control group (usual treatment). This research would provide a better understanding of the effectiveness of DBT in addiction treatment, as well as the effectiveness of solutions that improve its accessibility, such as the transdiagnostic format and the use of associated digital tools.
- Conditions
- Addiction Disorders, Emotional Dysregulation
- Being tested
- Face-to-face DBT, Online DBT, Usual treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face DBTBehavioural
One therapy session per week for two 3-month periods, to learn and practice emotional regulation skills.
Online DBTBehavioural
Two 3-months periods, consisting of watching a video on an emotional regulation skill and completing a worksheet related to that skill. In addition, participants will be encouraged to regularly use mobile apps on emotional regulation.
Usual treatmentBehavioural
Consultations in the addiction treatment department at a frequency deemed clinically necessary by the professional providing follow-up care. Occupational group therapy (discussion groups, writing, etc.) is usually offered to patients, who may participate as they wish.
| Study group | Role | What they receive |
|---|---|---|
| Patients with emotional dysregulation treated by face-to-face DBT | Experimental | Not described Receives: Behavioral: Face-to-face DBT |
| Patients with emotional dysregulation treated by online DBT | Experimental | Not described Receives: Behavioral: Online DBT |
| Patients with emotional dysregulation treated by usual treatment | Active comparator | Not described Receives: Behavioral: Usual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the Difficulties in Emotion Regulation Scale (DERS) measured at the first post-therapy follow-up visit (visit V2) in the face-to-face DBT group ant the control group
Measured: Between Day 90 and Day 150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Addiction DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amaury Durpoix, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310511
- Sponsor's protocol ID
- RC25-0041
- Acronym
- RégulAddict
- Status last verified
- Nov 2025
- First submitted
- 4 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Regulation & Addiction : Impact of In-person/Online Dialectic Behavior Therapy (DBT) vs Usual Treatment
- ClinicalTrials.gov ID
- NCT07310511
- Acronym / sponsor ID
- RégulAddict / RC25-0041
- Conditions
- Addiction Disorders, Emotional Dysregulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 30 Dec 2025 (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.
In psychiatry, psychotherapy is, along with pharmacotherapy, a major therapeutic intervention. It helps patients better understand their difficulties and informs them of possible solutions. It is systematically recommended in cases of psychiatric disorders, whether or not in combination with pharmacotherapy.
With regard to addictive disorders in particular, few medications are available and psychotherapy is essential. Psychotherapy must be adapted to the severity of the patient's condition and the issues encountered. In cases of impaired emotional regulation, i.e., the ability to respond effectively to one's emotions, addictions become more difficult to stabilize without appropriate treatment. For patients with emotional regulation disorders, Dialectical Behavior Therapy (DBT) is the standard treatment. It consists of teaching acceptance and change skills in a dialectical manner to better regulate emotions.
Like other evidence-based psychotherapies, DBT is nevertheless not widely available. It requires therapists to have a high level of training and sufficient patient recruitment to form groups. Two solutions are being considered to improve the accessibility of DBT. To facilitate patient recruitment, transdiagnostic groups are useful because they bring together patients with different diagnoses. To help professionals deliver the therapy, digital tools such as pre-recorded videos or mobile applications have proven effective, particularly when guided by a therapist, but they also show some effectiveness without a therapist. Studies are still recent and few in number, and need to be replicated, particularly using a variety of digital tools.
The investigators want to evaluate the effectiveness of DBT on emotional regulation and impulsivity in addiction patients, in a transdiagnostic face-to-face format and in an online format using videos, compared to a control group (usual treatment). This research would provide a better understanding of the effectiveness of DBT in addiction treatment, as well as the effectiveness of solutions that improve its accessibility, such as the transdiagnostic format and the use of associated digital tools.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with emotional dysregulation treated by face-to-face DBT | Experimental | Behavioral: Face-to-face DBT |
| Patients with emotional dysregulation treated by online DBT | Experimental | Behavioral: Online DBT |
| Patients with emotional dysregulation treated by usual treatment | Active comparator | Behavioral: Usual treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged >18 years
- Patients affiliated with a social security health insurance plan
- Patients who are fluent in French, able to understand the objectives and risks associated with the research, and able to give dated and signed informed consent
- Patients with addictive disorders (substance and/or behavioral) presenting emotional dysregulation (DERS score >90) in the 3 months prior to the inclusion visit
- Patients whose treatment(s) for mood disorder regulation has been stable for 3 months
Key exclusion criteria (7 listed)
- Patients diagnosed with acute psychosis
- Patients with major neurocognitive disorders
- Patients with encephalopathy
- Patients in a period of exclusion (determined by a previous or ongoing study)
- Patients in an emergency/life-threatening situation
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 |
|---|---|---|
| Face-to-face DBTOne therapy session per week for two 3-month periods, to learn and practice emotional regulation skills. | Behavioural | Patients with emotional dysregulation treated by face-to-face DBT |
| Online DBTTwo 3-months periods, consisting of watching a video on an emotional regulation skill and completing a worksheet related to that skill. In addition, participants will be encouraged to regularly use mobile apps on emotional regulation. | Behavioural | Patients with emotional dysregulation treated by online DBT |
| Usual treatmentConsultations in the addiction treatment department at a frequency deemed clinically necessary by the professional providing follow-up care. Occupational group therapy (discussion groups, writing, etc.) is usually offered to patients, who may participate as they wish. | Behavioural | Patients with emotional dysregulation treated by usual treatment |
Primary outcome
Score on the Difficulties in Emotion Regulation Scale (DERS) measured at the first post-therapy follow-up visit (visit V2) in the face-to-face DBT group ant the control group
Time frame: Between Day 90 and Day 150
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 30 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Amaury Durpoix principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face DBT, Online DBT and Usual treatment in people with Addiction Disorders and Emotional Dysregulation, run by University Hospital, Strasbourg, France at 1 site in France.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 30 Dec 2025. 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 France. 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?
Contact Amaury Durpoix (+33 88 11 64 25, amaury.durpoix@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the Difficulties in Emotion Regulation Scale (DERS) measured at the first post-therapy follow-up visit (visit V2) in the face-to-face DBT group ant the control group (time frame: Between Day 90 and Day 150). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2025.