Assessment of the Effectiveness of an Integrative Therapy for Cannabis Misuse in Adolescents (TIMCA)

Centre Hospitalier St Anne

Status: Enrolling

Conditions: Cannabis Use Disorder

Treatments: Other: Treatment as Usual; Other: TIMCA

Study type: Interventional

Funder types: Other

Identifiers

NCT05765409

D22-P019

Details and patient eligibility

About

The primary objective of this study is to evaluate an Integrative Therapy for Adolescent Cannabis Use (TIMCA), integrating elements of Motivational Interviewing (MI), Cognitive Behavioral Therapies (CBT) and an Attachment-Based Intervention (ABI), (IBA),compared to Treatment As Usual (TAU) on cannabis use.

The secondary objectives of the study are:

To assess the effectiveness of the TIMCA, in comparison to the TAU, on: (1) Relationship quality with parents, (2) Relationship quality with closest friend, (3) Emotional regulation strategies, (4) Depressive symptomatology, (5) Anxiety symptomatology, (6) Adherence to therapy

Full description

Cannabis is the most used psychoactive substance in the world after tobacco and alcohol, particularly among adolescents and young adults. Cannabis use during adolescence can lead to cognitive, psychological, academic, and social consequences, causing significant distress. In 2019, French adolescents reported one of the highest levels of cannabis experimentation and use (past month) in Europe (5th and 2nd respectively) (Philippon & Spilka, 2020). Regular use of cannabis during adolescence can cause or reinforce psychological suffering in both the young person and those around him/her, and therefore constitutes a major public health issue. Although psychotherapeutic techniques form the basis of treatment for Cannabis Use Disorder (CUD), relapse is common at the follow-up assessment after therapy has ended (Gates et al., 2016; Walther et al., 2016). The literature shows the effectiveness of Motivational Interviewing (MI) on the one hand, and psychotherapies such as Cognitive Behavioral Therapies (CBT) and Multidimensional Family Therapy (MDFT) on the other. The most consistent and coherent evidence supports the combination of CBT and MI to decrease the frequency and severity of cannabis use. As the combination of MI and CBT has proven to be effective with young users, it seems important to add an Attachment-Based Intervention (ABI), as difficulties with interpersonal relationships and emotional regulation are risk factors for the development and maintenance of addiction in adolescents (Fairbairn et al., 2018; Rahioui, 2016).

This randomized, single-blind, two-arm, parallel, multicenter trial postulates that participants in the TIMCA group will have better outcomes than those in the Treatment As Usual (TAU) group in terms of cannabis use, quality of relationship with others, emotional regulation strategies, as well as anxiety-depressive symptomatology (during therapy, at the end of therapy, and at four weeks after the end of therapy).

Enrollment: 100 estimated patients

Sex: All

Ages: 14 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 14 to 19 years 11 months 29 (or 30) days at the time of the inclusion visit
• Consulting as an outpatient center:
• Fulfilling the criteria for Cannabis Use Disorder (CUD) according to DSM 5 criteria (mild, moderate or severe)
• Fluent in oral and written French
• Benefiting from a social security plan
• Having signed their consent to participate (and their legal representative if applicable).

Exclusion criteria

• With an acute psychiatric disorder and/or a psychotropic treatment (a characterized depressive episode, a bipolar disorder, a psychotic disorder)
• With a substance use disorder other than cannabis and tobacco,
• Already engaged in another form of therapy
• Pregnant women at the time of inclusion
• Participants of age subject to a legal protection measure or unable to express their consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

TIMCA

Experimental group

Description:

The intervention will combine elements of motivational interviewing, cognitive and behavioral therapy and an attachment-based intervention. Sessions with both the adolescent and his parents are planned.

Treatment:

Other: TIMCA

Treatment as Usual

Active Comparator group

Description:

The comparator, an active control, will be Treatment As Usual" (TAU) group, i.e., the therapy usually practiced in the services. Given the multiplicity of investigating centers and the different treatments offered according to the patient's problems, it seems difficult to choose a single reference treatment for the control arm. Each investigating center undertakes to adopt the treatment that seems most effective and appropriate for each patient

Treatment:

Other: Treatment as Usual