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

Assessment of the Effectiveness of an Integrative Therapy for Cannabis Misuse in Adolescents (Randomized Controlled Trial of Non-inferiority)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05765409
Acronym
TIMCA
Enrollment
100
Registered
2023-03-13
Start date
2023-02-15
Completion date
2025-06-09
Last updated
2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cannabis Use Disorder

Keywords

Randomized Controlled Trial, Cannabis Use Disorder, Adolescents, Young adults, Motivational Interviewing, Cognitive and Behavioral Therapy, Attachment-based Intervention

Brief summary

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

Detailed 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).

Interventions

OTHERTIMCA

TIMCA is an individual therapy that will include the parents at certain points in the therapy . It will consist of two sessions of MI, two sessions of CBT, five sessions of ABI and one final session of summary to conclude the therapy. Out of 10 sessions, there will be three with the parents and the adolescent together.

OTHERTreatment as Usual

TAU will consist of several approaches including analytical, cognitive-behavioral , intepersonal psychotherapy. Each therapist will be asked to specify the approach used as well as the therapeutic axes.

Sponsors

Centre Hospitalier St Anne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

This will be a single-blinded, randomised, comparative therapeutic interventions, controlled trial. This is a prospective, randomized, single-blind, two-arm, parallel, multicenter study to evaluate the non-inferiority of an Integrative Therapy for Adolescent Cannabis Misuse (TIMCA) compared to the Treatment As Usual (TAU) control group using an Adaptive Group-Sequential non Inferiority Study Design. Two interim analyses are planned (when 30 and 60 subjects have completed the study). Both interventions will take place under similar conditions: 10 sessions, once a week, delivered by clinical psychologists who will be supervised.

Eligibility

Sex/Gender
ALL
Age
14 Years to 20 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cannabis use4 weeks after the end of treatmentCannabis use will be assessed via the TimeLine Follow Back (TLFB) (Robinson et al., 2014) and a urinanalysis (NarcoCheck)

Secondary

MeasureTime frameDescription
Parent and peer attachment4 weeks after the end of treatmentInventory of Parent and Peer attachment (IPPA) (Vignoli & Mallet, 2004)
Emotion regulation4 weeks after the end of treatmentThe Regulation of Emotions Questionnaire (REQ2) (Sequeira, 2013)
Anxiety symptomatology4 weeks after the end of treatmentThe Spielberger State-Trait Anxiety Inventory (STAI) (Spielberger et al., 1993)
Depressive symptomatology4 weeks after the end of treatmentBeck Depression Inventory (BDI) (Byrne & Baron, 1994)

Countries

France

Contacts

Primary ContactYara BOU NASSIF, psychologist
y.bou_nassif@ghu-paris.fr0630707681

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026