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

NCT05765409 | Unknown DMC

• 1 other identifier: D22-P019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Cannabis Use Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cannabis use

  Cannabis use will be assessed via the TimeLine Follow Back (TLFB) (Robinson et al., 2014) and a urinanalysis (NarcoCheck)

  4 weeks after the end of treatment

Secondary Outcomes (4)

• Parent and peer attachment

  4 weeks after the end of treatment

• Emotion regulation

  4 weeks after the end of treatment

• Anxiety symptomatology

  4 weeks after the end of treatment

• Depressive symptomatology

  4 weeks after the end of treatment

Study Arms (2)

TIMCA

EXPERIMENTAL

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.

Other: TIMCA

Treatment as Usual

ACTIVE COMPARATOR

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

Other: Treatment as Usual

Interventions

TIMCA OTHER

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.

TIMCA

Treatment as Usual OTHER

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.

Treatment as Usual

Eligibility Criteria

• Age: 14 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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
• Participants of age subject to a legal protection measure or unable to express their consent

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

GHU Paris Psychiatrie & Neurosciences

Paris, 75014, France

RECRUITING

MeSH Terms

Interventions

Therapeutics

Study Officials

• Hassan Rahioui, Doctor

  GHU Paris Psychiatry & Neurosciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yara BOU NASSIF, psychologist

CONTACT

0630707681; y.bou_nassif@ghu-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: February 15, 2023
• Primary Completion: June 9, 2025
• Study Completion: June 9, 2025
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

FR (1)