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

Primary Purpose

Cannabis Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TIMCA
Treatment as Usual
Sponsored by
Centre Hospitalier St Anne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use Disorder focused on measuring Randomized Controlled Trial, Cannabis Use Disorder, Adolescents, Young adults, Motivational Interviewing, Cognitive and Behavioral Therapy, Attachment-based Intervention

Eligibility Criteria

14 Years - 20 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • GHU Paris Psychiatrie & NeurosciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TIMCA

Treatment as Usual

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Parent and peer attachment
Inventory of Parent and Peer attachment (IPPA) (Vignoli & Mallet, 2004)
Emotion regulation
The Regulation of Emotions Questionnaire (REQ2) (Sequeira, 2013)
Anxiety symptomatology
The Spielberger State-Trait Anxiety Inventory (STAI) (Spielberger et al., 1993)
Depressive symptomatology
Beck Depression Inventory (BDI) (Byrne & Baron, 1994)

Full Information

First Posted
March 1, 2023
Last Updated
March 1, 2023
Sponsor
Centre Hospitalier St Anne
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1. Study Identification

Unique Protocol Identification Number
NCT05765409
Brief Title
Assessment of the Effectiveness of an Integrative Therapy for Cannabis Misuse in Adolescents
Acronym
TIMCA
Official Title
Assessment of the Effectiveness of an Integrative Therapy for Cannabis Misuse in Adolescents (Randomized Controlled Trial of Non-inferiority)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
June 9, 2025 (Anticipated)
Study Completion Date
June 9, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier St Anne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder
Keywords
Randomized Controlled Trial, Cannabis Use Disorder, Adolescents, Young adults, Motivational Interviewing, Cognitive and Behavioral Therapy, Attachment-based Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TIMCA
Arm Type
Experimental
Arm 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.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
TIMCA
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cannabis use
Description
Cannabis use will be assessed via the TimeLine Follow Back (TLFB) (Robinson et al., 2014) and a urinanalysis (NarcoCheck)
Time Frame
4 weeks after the end of treatment
Secondary Outcome Measure Information:
Title
Parent and peer attachment
Description
Inventory of Parent and Peer attachment (IPPA) (Vignoli & Mallet, 2004)
Time Frame
4 weeks after the end of treatment
Title
Emotion regulation
Description
The Regulation of Emotions Questionnaire (REQ2) (Sequeira, 2013)
Time Frame
4 weeks after the end of treatment
Title
Anxiety symptomatology
Description
The Spielberger State-Trait Anxiety Inventory (STAI) (Spielberger et al., 1993)
Time Frame
4 weeks after the end of treatment
Title
Depressive symptomatology
Description
Beck Depression Inventory (BDI) (Byrne & Baron, 1994)
Time Frame
4 weeks after the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yara BOU NASSIF, psychologist
Phone
0630707681
Ext
33
Email
y.bou_nassif@ghu-paris.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Rahioui, Doctor
Organizational Affiliation
GHU Paris Psychiatrie & Neurosciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
GHU Paris Psychiatrie & Neurosciences
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yara BOU NASSIF, psychologist
Phone
0630707681
Ext
33
Email
y.bou_nassif@ghu-paris.fr
First Name & Middle Initial & Last Name & Degree
Hassan RAHIOUI, Doctor
First Name & Middle Initial & Last Name & Degree
Yara BOU NASSIF, Psychologist

12. IPD Sharing Statement

Learn more about this trial

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

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