Comparing the Spanish Version of CANreduce With or Without Psychological Support and Treatment as Usual, Reducing Cannabis Use. (CANREDUCE)
Primary Purpose
Cannabis Use Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
CANreduce
psychological support
Sponsored by
About this trial
This is an interventional treatment trial for Cannabis Use Disorder focused on measuring Mental health, Adherence, Treatment, Cognitive behavioral therapy, Web-based Self-Help
Eligibility 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
Sites / Locations
- Juan-Ignacio Mestre-PintoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
CANreduce with psychological support
CANreduce without psychological support
Treatment as usual
Arm Description
Adherence-focused guidance enhanced web-based self-help for the reduction of cannabis use with psychological support
Adherence-focused guidance enhanced web-based self-help for the reduction of cannabis use without psychological support
Users will be prompt to a web with a list of the treatment centers nearby their postal code
Outcomes
Primary Outcome Measures
Change in the number of days of self-reported cannabis use in the past 30 days (TLFB)
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
Change in the number of days of weekly self-reported cannabis use Time Life Follow Back (TLFB)
Participants enter their cannabis consumption frequency into their consumption diary every week.
More days of self-reported cannabis use indicate a worse outcome
Change in the quantity of weekly standard joints (TLFB with predifined cannabis standard joints)
Participants enter their cannabis consumption quantity into their consumption diary every week.
More number of weekly standard joints indicate a worse outcome
Change in the scoring of the Cannabis Use Disorder Identification Test - Revised (CUDIT-R)
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
Change in the scoring of the Severity Dependence Scale (SDS)
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.
Change in the scoring of the Alcohol Use Disorders Identification Test (AUDIT)
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
Change in the scoring of the PROMIS Emotional Distress - Depression - Short Form 8b
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
Change in the scoring of the PROMIS Anxiety 8a - Adult v1.0
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
Change in the scoring of the EQ-5D-5L
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).
Full Information
NCT ID
NCT04517474
First Posted
August 12, 2020
Last Updated
November 5, 2021
Sponsor
Parc de Salut Mar
Collaborators
Research Institute for Public Health and Addiction, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT04517474
Brief Title
Comparing the Spanish Version of CANreduce With or Without Psychological Support and Treatment as Usual, Reducing Cannabis Use.
Acronym
CANREDUCE
Official Title
Evaluación de Una Herramienta E-Salud Para la reducción Del Consumo de Cannabis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Parc de Salut Mar
Collaborators
Research Institute for Public Health and Addiction, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder
Keywords
Mental health, Adherence, Treatment, Cognitive behavioral therapy, Web-based Self-Help
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CANreduce with psychological support
Arm Type
Experimental
Arm Description
Adherence-focused guidance enhanced web-based self-help for the reduction of cannabis use with psychological support
Arm Title
CANreduce without psychological support
Arm Type
Experimental
Arm Description
Adherence-focused guidance enhanced web-based self-help for the reduction of cannabis use without psychological support
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Users will be prompt to a web with a list of the treatment centers nearby their postal code
Intervention Type
Behavioral
Intervention Name(s)
CANreduce
Other Intervention Name(s)
CANreduce: Adherence-focused guidance enhanced web-based self-help for the reduction of cannabis use with psychological support
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
psychological support
Intervention Description
psychological support
Primary Outcome Measure Information:
Title
Change in the number of days of self-reported cannabis use in the past 30 days (TLFB)
Description
Participants enter their cannabis consumption frequency into their consumption diary every week.
More days of self-reported cannabis use indicate worse state
Time Frame
Baseline, 6, 12 and 24 weeks.
Secondary Outcome Measure Information:
Title
Change in the number of days of weekly self-reported cannabis use Time Life Follow Back (TLFB)
Description
Participants enter their cannabis consumption frequency into their consumption diary every week.
More days of self-reported cannabis use indicate a worse outcome
Time Frame
Baseline, 6, 12 and 24 weeks.
Title
Change in the quantity of weekly standard joints (TLFB with predifined cannabis standard joints)
Description
Participants enter their cannabis consumption quantity into their consumption diary every week.
More number of weekly standard joints indicate a worse outcome
Time Frame
Baseline, 6, 12 and 24 weeks.
Title
Change in the scoring of the Cannabis Use Disorder Identification Test - Revised (CUDIT-R)
Description
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
Time Frame
Baseline, 6, 12 and 24 weeks.
Title
Change in the scoring of the Severity Dependence Scale (SDS)
Description
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.
Time Frame
Baseline, 6, 12 and 24 weeks.
Title
Change in the scoring of the Alcohol Use Disorders Identification Test (AUDIT)
Description
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
Time Frame
Baseline, 6, 12 and 24 weeks.
Title
Change in the scoring of the PROMIS Emotional Distress - Depression - Short Form 8b
Description
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
Time Frame
Baseline, 6, 12 and 24 weeks.
Title
Change in the scoring of the PROMIS Anxiety 8a - Adult v1.0
Description
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
Time Frame
Baseline, 6, 12 and 24 weeks.
Title
Change in the scoring of the EQ-5D-5L
Description
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).
Time Frame
Baseline, 6, 12 and 24 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marta Torrens, PhD
Phone
0034933160697
Ext
1697
Email
mtorrens@imim.es
First Name & Middle Initial & Last Name or Official Title & Degree
Juan-Ignacio Mestre-Pinto, PhD
Phone
0034933160697
Email
jmestre@imim.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Torrens, PhD
Organizational Affiliation
Hospital del Mar Research Institute (IMIM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juan-Ignacio Mestre-Pinto
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan-Ignacio Mestre-Pinto, PhD
Email
jmestre@imim.es
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29386176
Citation
Amann M, Haug S, Wenger A, Baumgartner C, Ebert DD, Berger T, Stark L, Walter M, Schaub MP. The Effects of Social Presence on Adherence-Focused Guidance in Problematic Cannabis Users: Protocol for the CANreduce 2.0 Randomized Controlled Trial. JMIR Res Protoc. 2018 Jan 31;7(1):e30. doi: 10.2196/resprot.9484.
Results Reference
background
PubMed Identifier
26462848
Citation
Schaub MP, Wenger A, Berg O, Beck T, Stark L, Buehler E, Haug S. A Web-Based Self-Help Intervention With and Without Chat Counseling to Reduce Cannabis Use in Problematic Cannabis Users: Three-Arm Randomized Controlled Trial. J Med Internet Res. 2015 Oct 13;17(10):e232. doi: 10.2196/jmir.4860.
Results Reference
background
PubMed Identifier
35733201
Citation
Mestre-Pinto JI, Fonseca F, Schaub MP, Baumgartner C, Alias-Ferri M, Torrens M. CANreduce-SP-adding psychological support to web-based adherence-focused guided self-help for cannabis users: study protocol for a three-arm randomized control trial. Trials. 2022 Jun 22;23(1):524. doi: 10.1186/s13063-022-06399-2.
Results Reference
derived
Links:
URL
http://canreduce.es
Description
Web of the Spanish study (in Spanish)
URL
http://canreduce.at
Description
Web of the Swiss study (in German)
Learn more about this trial
Comparing the Spanish Version of CANreduce With or Without Psychological Support and Treatment as Usual, Reducing Cannabis Use.
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