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

NCT07310511 | Not Yet Recruiting

• 1 other identifier: RC25-0041
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Addiction Disorders; Emotional Dysregulation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

Interventions

Face-to-face DBT BEHAVIORAL

One therapy session per week for two 3-month periods, to learn and practice emotional regulation skills.

Patients with emotional dysregulation treated by face-to-face DBT

Online DBT BEHAVIORAL

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 online DBT

Usual treatment BEHAVIORAL

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.

Patients with emotional dysregulation treated by usual treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 whose treatment(s) for mood disorder regulation has been stable for 3 months
• No ongoing structured psychotherapy

You may not qualify if:

• Patients diagnosed with acute psychosis
• Patients with major neurocognitive disorders
• Patients with encephalopathy
• Patients in an emergency/life-threatening situation
• Patients under legal protection
• Pregnancy (self-reported)/breastfeeding

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Location

Study Officials

• Amaury Durpoix

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amaury Durpoix

CONTACT

+33 88 11 64 25; amaury.durpoix@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 30, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: December 30, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)