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

University Hospital, Strasbourg, France

Status: Not yet enrolling

Conditions: Addiction Disorders; Emotional Dysregulation

Treatments: Behavioral: Face-to-face DBT; Behavioral: Usual treatment; Behavioral: Online DBT

Study type: Interventional

Funder types: Other

Identifiers

NCT07310511

RC25-0041

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

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

Experimental group

Treatment:

Behavioral: Face-to-face DBT

Patients with emotional dysregulation treated by online DBT

Experimental group

Treatment:

Behavioral: Online DBT

Patients with emotional dysregulation treated by usual treatment

Active Comparator group

Treatment:

Behavioral: Usual treatment