The Effects of Social Presence on Adherence-Focused Guidance in Problematic Cannabis Users: Protocol for the CANreduce 2.0 Randomized Controlled Trial

Manuel Amann, Severin Haug, Andreas Wenger, Christian Baumgartner, David D Ebert, Thomas Berger, Lars Stark, Marc Walter, Michael P Schaub, Manuel Amann, Severin Haug, Andreas Wenger, Christian Baumgartner, David D Ebert, Thomas Berger, Lars Stark, Marc Walter, Michael P Schaub

Abstract

Background: In European countries, including Switzerland, cannabis is the most commonly used illicit drug. Offering a Web-based self-help tool could potentially reach users who otherwise would not seek traditional help. However, such Web-based self-help tools often suffer from low adherence.

Objective: Through adherence-focused guidance enhancements, the aim of this study was to increase adherence in cannabis users entering a Web-based self-help tool to reduce their cannabis use and, in this way, augment its effectiveness.

Methods: This paper presents the protocol for a three-arm randomized controlled trial (RCT) to compare the effectiveness of (1) an adherence-focused, guidance-enhanced, Web-based self-help intervention with social presence; (2) an adherence-focused, guidance-enhanced, Web-based self-help intervention without social presence; and (3) a treatment-as-usual at reducing cannabis use in problematic users. The two active interventions, each spanning 6 weeks, consist of modules designed to reduce cannabis use and attenuate common mental disorder (CMD) symptoms, including depression, anxiety, and stress-related disorder symptoms based on the approaches of motivational interviewing and cognitive behavioral therapy. With a target sample size of 528, data will be collected at baseline, 6 weeks, and 3 months after baseline. The primary outcome measurement will be the number of days of cannabis use on the preceding 7 days. Secondary outcomes will include the quantity of cannabis used in standardized cannabis joints, the severity of cannabis dependence, changes in CMD symptoms, and adherence to the program. Data analysis will follow the intention-to-treat principle and employ (generalized) linear mixed models.

Results: The project commenced in August 2016; recruitment is anticipated to end by December 2018. First results are expected to be submitted for publication in summer 2019.

Conclusions: This study will provide detailed insights on if and how the effectiveness of a Web-based self-help intervention aiming to reduce cannabis use in frequent cannabis users can be improved by theory-driven, adherence-focused guidance enhancement.

Trial registration: International Standard Randomized Controlled Trial Number Registry: ISRCTN11086185; http://www.isrctn.com/ISRCTN11086185 (Archived by WebCite at http://www.webcitation.org/6wspbuQ1M).

Keywords: adherence; cannabis; cognitive behavioral therapy; mental disorders; mobile health; social presence.

Conflict of interest statement

Conflicts of Interest: None declared.

©Manuel Amann, Severin Haug, Andreas Wenger, Christian Baumgartner, David D Ebert, Thomas Berger, Lars Stark, Marc Walter, Michael P Schaub. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 31.01.2018.

Figures

Figure 1
Figure 1
Trial flowchart.
Figure 2
Figure 2
Dashboard for study arm 1 (translated from German to English for publication purposes only).
Figure 3
Figure 3
Main menu (translated from German to English for publication purposes only).

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