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Comparing the Spanish Version of CANreduce With or Without Psychological Support and Treatment as Usual, Reducing Cannabis Use. (CANREDUCE)

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ClinicalTrials.gov Identifier: NCT04517474
Recruitment Status : Recruiting
First Posted : August 18, 2020
Last Update Posted : January 22, 2021
Sponsor:
Collaborator:
Research Institute for Public Health and Addiction, Switzerland
Information provided by (Responsible Party):
Parc de Salut Mar

Study Description
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Brief Summary:

Cannabis is the most widely used psychoactive substance around the world after alcohol and tobacco. Although approximately one in ten users develop serious problems of dependency, only a small number attend outpatient addiction counseling centers. CANreduce is an adherence-focused guidance enhanced web-based self-help program with promising results in German and other languages. It also reaches those users who hesitate to approach such treatment centers and help them to reduce their cannabis use.

This study will test the effectiveness of the Spanish version of the enhanced web-based self-help intervention with psychological support, an enhanced web-based self-help intervention (without psychological support) and a waiting list control in reducing cannabis use in problematic users.


Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Behavioral: CANreduce Behavioral: psychological support Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: The masking technique will be partially single-blinded-in that participants in either of the two active treatment groups will not know which version they work with. The two versions are neutrally described as two differently optimized variants to prevent participants from having a preference of one over the other possibly resulting in a disappointment when being allocated to the unwished version. However, subjects will know whether they have been assigned to treatment-as-usual (TAU). Any blinding of research and study personnel is not warranted.
Primary Purpose: Treatment
Official Title: Evaluación de Una Herramienta E-Salud Para la reducción Del Consumo de Cannabis
Actual Study Start Date : November 10, 2020
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arms and Interventions
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Arm Intervention/treatment
Experimental: CANreduce with psychological support
Adherence-focused guidance enhanced web-based self-help for the reduction of cannabis use with psychological support
 Behavioral: CANreduce
CANreduce is an automated web-based self-help tool based on classical Cognitive Behavioral Treatment (CBT) approaches for treating cannabis dependence. It will consist of a consumption diary, eight modules designed to reduce cannabis use based on the principles of motivational interviewing, self-control practices, and methods of cognitive behavioral therapy ( strategies for goal achievement, Identifying risk situations, Dealing with cannabis craving, Dealing with relapses, Working on needs, Saying "no" to foster refusal skills, Dealing with burdens, Preserving achievements). Participants can study all modules at their own pace and order, though a specific order will be advised.
Other Name: CANreduce: Adherence-focused guidance enhanced web-based self-help for the reduction of cannabis use with psychological support

Behavioral: psychological support
psychological support
Experimental: CANreduce without psychological support
Adherence-focused guidance enhanced web-based self-help for the reduction of cannabis use without psychological support
 Behavioral: CANreduce
CANreduce is an automated web-based self-help tool based on classical Cognitive Behavioral Treatment (CBT) approaches for treating cannabis dependence. It will consist of a consumption diary, eight modules designed to reduce cannabis use based on the principles of motivational interviewing, self-control practices, and methods of cognitive behavioral therapy ( strategies for goal achievement, Identifying risk situations, Dealing with cannabis craving, Dealing with relapses, Working on needs, Saying "no" to foster refusal skills, Dealing with burdens, Preserving achievements). Participants can study all modules at their own pace and order, though a specific order will be advised.
Other Name: CANreduce: Adherence-focused guidance enhanced web-based self-help for the reduction of cannabis use with psychological support
No Intervention: Treatment as usual
Users will be prompt to a web with a list of the treatment centers nearby their postal code


Outcome Measures
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Primary Outcome Measures :
  1. Change in the number of days of self-reported cannabis use in the past 30 days (TLFB) [ Time Frame: Baseline, 6, 12 and 24 weeks. ]

    Participants enter their cannabis consumption frequency into their consumption diary every week.

    More days of self-reported cannabis use indicate worse state



Secondary Outcome Measures :
  1. Change in the number of days of weekly self-reported cannabis use Time Life Follow Back (TLFB) [ Time Frame: Baseline, 6, 12 and 24 weeks. ]

    Participants enter their cannabis consumption frequency into their consumption diary every week.

    More days of self-reported cannabis use indicate a worse outcome


  2. Change in the quantity of weekly standard joints (TLFB with predifined cannabis standard joints) [ Time Frame: Baseline, 6, 12 and 24 weeks. ]

    Participants enter their cannabis consumption quantity into their consumption diary every week.

    More number of weekly standard joints indicate a worse outcome


  3. Change in the scoring of the Cannabis Use Disorder Identification Test - Revised (CUDIT-R) [ Time Frame: Baseline, 6, 12 and 24 weeks. ]

    CUDIT-R was developed containing 8 items, two each from the domains of consumption, cannabis problems (abuse), dependence, and psychological features. It has excellent psychometric properties. High sensitivity (91%) and specificity (90%).

    This questionnaire was designed for self administration and is scored by adding each of the 8 items:

    • Question 1-7 are scored on a 0-4 scale (range 0-28)
    • Question 8 is scored 0, 2 or 4.
    • Score range 0-32 Scores of 8 or more indicate hazardous cannabis use, while scores of 12 or more indicate a possible cannabis use disorder for which further intervention may be required.

    Higher scores indicate a worse outcome


  4. Change in the scoring of the Severity Dependence Scale (SDS) [ Time Frame: Baseline, 6, 12 and 24 weeks. ]
    SDS is a standard instrument to assess the severity to any drug dependence. Each of the five items is scored on a 4-point scale (0-3). The total score is obtained through the addition of the 5-item ratings (0-15). The higher the score the higher the level of dependence.

  5. Change in the scoring of the Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: Baseline, 6, 12 and 24 weeks. ]
    AUDIT is a 10-item screening tool developed by the World Health Organization (WHO) to assess alcohol consumption, drinking behaviors, and alcohol-related problems. Each item scores 0-4, The total score ranges from 0-40. A score of 8 or more is considered to indicate hazardous or harmful alcohol use. The AUDIT has been validated across genders and in a wide range of racial/ethnic groups and is well suited for use in primary care settings. Higher scores indicate a worse outcome

  6. Change in the scoring of the PROMIS Emotional Distress - Depression - Short Form 8b [ Time Frame: Baseline, 6, 12 and 24 weeks. ]

    PROMIS (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Developed and validated with state-of-the-science methods to be psychometrically sound and to transform how life domains are measured.

    8 items 1-5, score ranges 8-40 Higher scores indicate a worse outcome


  7. Change in the scoring of the PROMIS Anxiety 8a - Adult v1.0 [ Time Frame: Baseline, 6, 12 and 24 weeks. ]

    PROMIS (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Developed and validated with state-of-the-science methods to be psychometrically sound and to transform how life domains are measured.

    8 items 1-5, score ranges 8-40 Higher scores indicate a worse outcome


  8. Change in the scoring of the EQ-5D-5L [ Time Frame: Baseline, 6, 12 and 24 weeks. ]

    EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

    Score ranges from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health),

    The second part of the questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cannabis use of at least once a week 30 days prior to study entry
  • At least 18 years old
  • At least weekly internet access and a valid email address

Exclusion Criteria:

  • Participant reports current pharmacological psychiatric disease or history of psychosis, schizophrenia, bipolar type I disorder or significant current suicidal or homicidal thoughts
  • Use of other pharmacological and psychosocial treatments for cannabis use disorders
  • Inability to read or write in Spanish
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04517474


Contacts
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Contact: Marta Torrens, PhD 0034933160697 ext 1697 mtorrens@imim.es
Contact: Juan-Ignacio Mestre-Pinto, PhD 0034933160697 jmestre@imim.es

Locations
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Spain
Juan-Ignacio Mestre-Pinto Recruiting
Barcelona, Catalunya, Spain, 08003
Contact: Juan-Ignacio Mestre-Pinto, PhD       jmestre@imim.es   
Sponsors and Collaborators
Parc de Salut Mar
Research Institute for Public Health and Addiction, Switzerland
Investigators
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Principal Investigator: Marta Torrens, PhD Hospital del Mar Research Institute (IMIM)
More Information
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Additional Information:

Publications:

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Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT04517474    
Other Study ID Numbers: 2019/8901/I
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Parc de Salut Mar:
Mental health
Adherence, Treatment
Cognitive behavioral therapy
Web-based Self-Help
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders