Emotional Regulation & Addiction : Impact of In-person/Online Dialectic Behavior Therapy (DBT) vs Usual Treatment (RégulAddict)

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 Overview

• Status: Not yet recruiting
• Conditions: Emotional Dysregulation; Addiction Disorders
• Intervention / Treatment: Behavioral: Face-to-face DBT; Behavioral: Online DBT; Behavioral: Usual treatment

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amaury Durpoix; Phone Number: +33 88 11 64 25; Email: amaury.durpoix@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France
    • Hôpitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with emotional dysregulation treated by face-to-face DBT	Behavioral: Face-to-face DBT; One therapy session per week for two 3-month periods, to learn and practice emotional regulation skills.
Experimental: Patients with emotional dysregulation treated by online DBT	Behavioral: 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.
Active Comparator: Patients with emotional dysregulation treated by usual treatment	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Between Day 90 and Day 150

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Amaury Durpoix, Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: RC25-0041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No