Emotional Regulation & Addiction : Impact of In-person/Online Dialectic Behavior Therapy (DBT) vs Usual Treatment
NCT ID: NCT07310511
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2026-01-31
2030-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Patients with emotional dysregulation treated by face-to-face DBT
Face-to-face DBT
One therapy session per week for two 3-month periods, to learn and practice emotional regulation skills.
Patients with emotional dysregulation treated by online DBT
Online DBT
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.
Patients with emotional dysregulation treated by usual treatment
Usual treatment
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.
Interventions
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Face-to-face DBT
One therapy session per week for two 3-month periods, to learn and practice emotional regulation skills.
Online DBT
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 treatment
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Principal Investigators
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Amaury Durpoix
Role: PRINCIPAL_INVESTIGATOR
Hôpitaux Universitaires de Strasbourg
Locations
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Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
Countries
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Central Contacts
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Other Identifiers
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RC25-0041
Identifier Type: -
Identifier Source: org_study_id