Clinical trial NCT04517474: Comparing the Spanish Version of CANreduce With or Without Psychological Support and Treatment as Usual, Reducing Cannabis Use.
Official title: Evaluación de Una Herramienta E-Salud Para la reducción Del Consumo de Cannabis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cannabis Use Disorder
Keywords: Mental health
Adherence, Treatment
Cognitive behavioral therapy
Web-based Self-Help
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Research Institute for Public Health and Addiction, Switzerland
First posted: 2020-08-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in the number of days of self-reported cannabis use in the past 30 days (TLFB)
timeFrame: Baseline, 6, 12 and 24 weeks.
Secondary outcomes:
measure: Change in the number of days of weekly self-reported cannabis use Time Life Follow Back (TLFB)
timeFrame: Baseline, 6, 12 and 24 weeks.
measure: Change in the quantity of weekly standard joints (TLFB with predifined cannabis standard joints)
timeFrame: Baseline, 6, 12 and 24 weeks.
measure: Change in the scoring of the Cannabis Use Disorder Identification Test - Revised (CUDIT-R)
timeFrame: Baseline, 6, 12 and 24 weeks.
measure: Change in the scoring of the Severity Dependence Scale (SDS)
timeFrame: Baseline, 6, 12 and 24 weeks.
measure: Change in the scoring of the Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Baseline, 6, 12 and 24 weeks.
measure: Change in the scoring of the PROMIS Emotional Distress - Depression - Short Form 8b
timeFrame: Baseline, 6, 12 and 24 weeks.
measure: Change in the scoring of the PROMIS Anxiety 8a - Adult v1.0
timeFrame: Baseline, 6, 12 and 24 weeks.
measure: Change in the scoring of the EQ-5D-5L
timeFrame: Baseline, 6, 12 and 24 weeks.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Juan-Ignacio Mestre-Pinto
state: Catalunya
Study officials:
affiliation: Hospital del Mar Research Institute (IMIM)
name: Marta Torrens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.