Snow Control 2.0 - web-based interventions for the reduction of cocaine use

• Register: ISRCTN
• Last refreshed on: 14 October 2019
• Main ID: ISRCTN12205466
• Date of registration: 24/02/2015
• Prospective Registration: Yes
• Primary sponsor: Swiss National Science Foundation
• Public title: Snow Control 2.0 - web-based interventions for the reduction of cocaine use
• Scientific title: Snow Control 2.0 - the effects of chat-counseling and web-based self-help, web-based self-help alone and a waiting list control program on cocaine use in problematic cocaine users: a randomized controlled trial
• Date of first enrolment: 01/03/2015
• Target sample size: 432
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN12205466
• Study type: Interventional
• Study design: This is an Internet-based interventional three-arm randomized controlled trial. (Treatment)
• Phase: Not Applicable

Countries of recruitment

Switzerland

Contacts

• Name: Michael P Schaub

Key inclusion & exclusion criteria

Inclusion criteria:
1. Cocaine use > 4 occasions last 30 days
2. Minimal age of 18 years

Exclusion criteria:
1. Participation in other psycho-social or pharmacological treatments for the reduction/cessation of cocaine use
2. Opioid use during last 30 days (exception: substitution maintenance treatment for opioid dependence without heroin use last 30 days)
3. Ever been in treatment for cardiovascular problems or apoplexy


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Problematic cocaine use.
Mental and Behavioural Disorders

Intervention(s)

Study interventions:
The intervention in the first arm consists of the web-based self-help intervention from study arm two in combination with three individual chat-counseling sessions based on MI and CBT approaches that are tailored to the data the participants entered into the self-help intervention, the exploration and improvement of current social support and relationships unrelated to cocaine use and individual requests. The web-based self-help intervention from study arm two is based on classical CBT, approaches for the treatment of cocaine dependence, MI approaches, BSM and CBT depression therapy. Study arm three consists of a classical waiting list.

Intervention modules:
The following modules, organized into two main parts, are offered as a web-based self-help intervention (study arms one and two) and accessible after successful registration and completion of baseline assessment. Part 1 has to be worked through systematically. Part 2 is presented in a clearly arranged menu and its modules are freely accessible as soon as part 1 is completed and recommended to be worked through in the order presented below in case there are no urgent personal reasons to jump to a specific module such as present strong craving etc. Corresponding participants are also recommended to repeat the modules as needed.
1. Part 1: Introduction
1.1. Registration process
1.2. Personal companion (introduction of 6 companion profiles and personal choice of own companion)
1.3. Examination of the pros and cons resulting from a change in cocaine consumption patterns to address motivation
1.4. Goal setting and explanation of the e-mail reminders
1.5. Explanation of the cocaine consumption diary and its fully automated progress charts and statistics
1.6. Explanation of the “My Snow Control” folder (This folder allows in

Primary Outcome(s)

The weekly quantity of cocaine use expressed in grams in the consumption diary, a measurement that has been shown to be very promising in the first preliminary Snow Control study.

Secondary Outcome(s)

1. Severity of Dependence Scale (SDS), a 5-item questionnaire that indicates the severity of dependence on cocaine. 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. High scores indicate a high level of dependency.
2. The weekly number of cocaine use days in the last 30 days
3. The “Fragebogen Substanzanamnese” (FDA) that ascertains the years of lifetime consumption, the past month’s consumption, and the way of consumption for the DSM-IV/ICD-10 substances of abuse. This measure was derived from the EuropeASI.
4. The short version of the Mental Health Inventory (MHI-5) which is a validated and user-friendly self-assessment questionnaire that assesses recent mental distress and self-reported diagnoses of depression.
5. The Social Support Appraisals (SS-A) Scale is a 23 item outcome measure assessed by a four point Likert scale ranging from 1 (strongly agree) to 4 (strongly disagree) that measures subjective appraisal of social support, designed to tap into the extent to which an individual believes that he or she is loved by, esteemed by, and involved with family, friends and others. This measure has been shown to predict relationships with a range of measures of support appraisals, support resources, and psychological distress.
6. The Working Alliance Inventory (WAI-SR) is a 12-item, self-report questionnaire consisting of three subscales designed to assess three primary components of the working alliance.
6.1. How closely client and therapist agree on and are mutually engaged in the goals of treatment
6.2. How closely client and therapist agree on how to reach the treatment goals
6.3. The degree of mutual trust, acceptance, and confidence between client and therapist. The composite score is used as a global measurement of working alliance. Respondents are asked to rate each statement on a 7-point Likert scale ranging from 1 (never) to 7 (always).
7. Client intervention satisfaction will be ascertained with the client satisfaction questionnaire (CSQ-4), a brief user-friendly instrument with good psychometric properties that has been tested in numerous studies on diverse client samples. Intervention retention will be derived from the last cocaine use input entered into the consumption diary in study arms one and two. Finally, self-help intervention participation will be measured by the consumption diary entries, the number of completed modules and the number of logins in the login history in study arm 1 and 2 during the 6 weeks of intervention.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Schweizerische Nationalfonds zur Förderung der Wissenschaftlichen Forschung

Ethics review

Status:
Approval date:
Contact:

Ethics committee of the Canton of Zurich, 02/02/2015, ref: KEK-ZH-No. 2014-0611

Results

• Results available: Yes
• Date Completed: 31/08/2017