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

NCT04517474 | Unknown

• 1 other identifier: 2019/8901/I
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use Disorder

Keywords

Mental health; Adherence, Treatment; Cognitive behavioral therapy; Web-based Self-Help

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 6, 12 and 24 weeks.

Secondary Outcomes (8)

• Change in the number of days of weekly self-reported cannabis use Time Life Follow Back (TLFB)

  Baseline, 6, 12 and 24 weeks.

• Change in the quantity of weekly standard joints (TLFB with predifined cannabis standard joints)

  Baseline, 6, 12 and 24 weeks.

• Change in the scoring of the Cannabis Use Disorder Identification Test - Revised (CUDIT-R)

  Baseline, 6, 12 and 24 weeks.

• Change in the scoring of the Severity Dependence Scale (SDS)

  Baseline, 6, 12 and 24 weeks.

• Change in the scoring of the Alcohol Use Disorders Identification Test (AUDIT)

  Baseline, 6, 12 and 24 weeks.

Study Arms (3)

CANreduce with psychological support

EXPERIMENTAL

Adherence-focused guidance enhanced web-based self-help for the reduction of cannabis use with psychological support

Behavioral: CANreduce; Behavioral: psychological support

CANreduce without psychological support

EXPERIMENTAL

Adherence-focused guidance enhanced web-based self-help for the reduction of cannabis use without psychological support

Behavioral: CANreduce

Treatment as usual

NO INTERVENTION

Users will be prompt to a web with a list of the treatment centers nearby their postal code

Interventions

CANreduce BEHAVIORAL

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.

Also known as: CANreduce: Adherence-focused guidance enhanced web-based self-help for the reduction of cannabis use with psychological support

CANreduce with psychological support; CANreduce without psychological support

psychological support BEHAVIORAL

psychological support

CANreduce with psychological support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Research Institute for Public Health and Addiction, Switzerland: collaborator

Study Sites (1)

Juan-Ignacio Mestre-Pinto

Barcelona, Catalonia, 08003, Spain

RECRUITING

Related Publications (3)

• 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.

  PMID: 29386176 BACKGROUND

• 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.

  PMID: 26462848 BACKGROUND

• 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.

  PMID: 35733201 DERIVED

Related Links

• Web of the Spanish study (in Spanish)
• Web of the Swiss study (in German)

MeSH Terms

Conditions

Psychological Well-Being; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Health Behavior

Study Officials

• Marta Torrens, PhD

  Hospital del Mar Research Institute (IMIM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Torrens, PhD

CONTACT

0034933160697; mtorrens@imim.es

Juan-Ignacio Mestre-Pinto, PhD

CONTACT

0034933160697; jmestre@imim.es

Study Design

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

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 18, 2020
• Study Start: November 10, 2020
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)