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Internet-Based Treatment for Individuals With Regular Cannabis Use: A Randomized Controlled Trial

Primary Purpose

Cannabis

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cannabishjalpen.se
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis focused on measuring Internet-Based, Treatment

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >15
  • Cannabis use 1 time/week or more often during the past six months.

Exclusion Criteria:

-

Sites / Locations

  • Center for Psychiatric Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Individuals randomized to the intervention group will directly after randomization answer questions about alcohol and drug use (other than alcohol and cannabis), depression, anxiety, a sense of context and whether they during the last 12 months has received professional help to reduce or quit their cannabis use or during the same period have raised this issue with their relatives or friends. Further, they will fill out a survey about Internet-based services for individuals who wish to reduce or quit their cannabis use. The study participants will then be informed that they, within two days, will gain access to an internet based treatment program designed to help them quit their cannabis use and that they through the program will be able to communicate with a therapist. Within the next two days, they will gain access to the internet-based treatment program, they will have access to it for two months and they will be contacted again after three months to complete the follow-up.

Individuals randomized to the control group will undergo exactly the same procedure as the intervention group. The difference is that the control group will be informed that they in about three months will gain access to an internet based treatment program designed to help them quit their cannabis use (i.e. when the data collection for follow-up is completed). Otherwise, participants in both groups will have the opportunity to use factual information that is available to everyone on Cannabishjalpen.se.

Outcomes

Primary Outcome Measures

Number of days without cannabis use.

Secondary Outcome Measures

Grams of cannabis consumed.
Reduction in frequency of cannabis use.
Number of DSM-V criteria for cannabis dependence.
Total score on Cannabis Abuse Screening Test (CAST).
Total score range 0-24 where higher scores indicate worse outcome.
Receiving professional help for cannabis use from relatives or friends.
Receiving help for cannabis use from relatives or friends.
Number of standard (alcohol) drinks.
Total score on Sense of coherence Scale.
Total score range13-91, where higher scores indicate better outcome.
Total score on Montgomery Åsberg Depression Rating Scale - Self reported (MADRS-S).
Total score range 0-60 where higher scores indicate worse outcome.
Total score on Generalized Anxiety Disorder Assessment (GAD-7).
Total score range 0-21 where higher scores indicate worse outcome.

Full Information

First Posted
March 26, 2015
Last Updated
July 26, 2019
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02408640
Brief Title
Internet-Based Treatment for Individuals With Regular Cannabis Use: A Randomized Controlled Trial
Official Title
Internet-Based Treatment for Individuals With Regular Cannabis Use: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 26, 2015 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

5. Study Description

Brief Summary
The aim of this randomized controlled trial is to investigate the effects of a Swedish Internet-based treatment program for individuals from the general population with a regular cannabis use. The primary hypothesis to be tested is that the use of the Internet-based treatment program will be associated with more cannabis-free days in comparison to only access to information about cannabis use and its harmful effects. The secondary hypotheses to be tested are: That the use of the Internet-based treatment program will be associated with a larger decline in cannabis consumption (frequency and quantity) among individuals with regular cannabis use in comparison to only access to information about Cannabis use and its harmful effects. That the use of the Internet-based treatment program will be associated with a larger decline in alcohol consumption, depression and anxiety and increased sense of coherence in comparison to only access to information about Cannabis use and its harmful effects. That the proportion of individuals who seek professional help or talk to their relatives or friends about reducing or stopping cannabis use will be greater among those who use the Internet-based treatment program than among those who only have access to information about cannabis use and its harmful effects. Recruitment procedure and baseline measures Study participants will be recruited through an advertisement on Cannabishjalpen.se. Interested individuals will answer questions about gender, age, country of birth, educational attainment, employment, marital status, living situation, and cannabis use. The intervention group Individuals randomized to the intervention group will directly after randomization answer questions about alcohol use, use of drugs other than alcohol and cannabis, depression, anxiety, a sense of context and whether they during the last 12 months has received professional help to reduce or quit their cannabis use or during the same period have raised this issue with their relatives or friends. Further, they will fill out a survey on Internet-based services for individuals who wish to reduce or quit their cannabis use. The study participants will then be informed that they, within two days, will gain access to an internet based treatment program designed to help them quit their cannabis use and that they through the program will have the opportunity to communicate with a therapist. Within the next two days, they will gain access to the internet-based treatment program, they will have access to it for two months and they will be contacted again after three months to answer questions about their cannabis and alcohol use, as well as about other previously mentioned issues. The control group Individuals randomized to the control group will undergo exactly the same procedure as the intervention group. The difference is that the control group will be informed that they in about three months will gain access to an internet based treatment program designed to help them quit their cannabis use (i.e. when the data collection for follow-up is completed). Otherwise, participants in both groups will have the opportunity to use factual information that is available to everyone on Cannabishjalpen.se. Follow-up procedure Study participants who were randomized to the intervention group will have access to intervention in two months. Three months after recruitment to the study, study participants from both groups will get an automated email invitation to participate in the three-month follow-up. The email will include a personalized link that when clicked on will redirect the participant to follow-up page where they will be asked to once again answer questions about their cannabis and alcohol use, depression and anxiety, seeking professional help for cannabis use as well as the help of family or friends and questions about whether they have used any other internet or telephone services to reduce or quit their cannabis use. The entire follow-up procedure will be completed via the internet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis
Keywords
Internet-Based, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
303 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Individuals randomized to the intervention group will directly after randomization answer questions about alcohol and drug use (other than alcohol and cannabis), depression, anxiety, a sense of context and whether they during the last 12 months has received professional help to reduce or quit their cannabis use or during the same period have raised this issue with their relatives or friends. Further, they will fill out a survey about Internet-based services for individuals who wish to reduce or quit their cannabis use. The study participants will then be informed that they, within two days, will gain access to an internet based treatment program designed to help them quit their cannabis use and that they through the program will be able to communicate with a therapist. Within the next two days, they will gain access to the internet-based treatment program, they will have access to it for two months and they will be contacted again after three months to complete the follow-up.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Individuals randomized to the control group will undergo exactly the same procedure as the intervention group. The difference is that the control group will be informed that they in about three months will gain access to an internet based treatment program designed to help them quit their cannabis use (i.e. when the data collection for follow-up is completed). Otherwise, participants in both groups will have the opportunity to use factual information that is available to everyone on Cannabishjalpen.se.
Intervention Type
Behavioral
Intervention Name(s)
Cannabishjalpen.se
Primary Outcome Measure Information:
Title
Number of days without cannabis use.
Time Frame
Past seven days
Secondary Outcome Measure Information:
Title
Grams of cannabis consumed.
Time Frame
Past three months
Title
Reduction in frequency of cannabis use.
Time Frame
Past three months
Title
Number of DSM-V criteria for cannabis dependence.
Time Frame
Past three months
Title
Total score on Cannabis Abuse Screening Test (CAST).
Description
Total score range 0-24 where higher scores indicate worse outcome.
Time Frame
Past three months
Title
Receiving professional help for cannabis use from relatives or friends.
Time Frame
Past three months
Title
Receiving help for cannabis use from relatives or friends.
Time Frame
Past three months
Title
Number of standard (alcohol) drinks.
Time Frame
Past seven days.
Title
Total score on Sense of coherence Scale.
Description
Total score range13-91, where higher scores indicate better outcome.
Time Frame
Past three months
Title
Total score on Montgomery Åsberg Depression Rating Scale - Self reported (MADRS-S).
Description
Total score range 0-60 where higher scores indicate worse outcome.
Time Frame
Past three months
Title
Total score on Generalized Anxiety Disorder Assessment (GAD-7).
Description
Total score range 0-21 where higher scores indicate worse outcome.
Time Frame
Past three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >15 Cannabis use 1 time/week or more often during the past six months. Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina Sinadinovic, PhD
Organizational Affiliation
Karolinska Institutet, Department of Clinical Neuroscience, Center for Psychiatric Research and Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Psychiatric Research
City
Stockholm
ZIP/Postal Code
113 64
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
32070417
Citation
Sinadinovic K, Johansson M, Johansson AS, Lundqvist T, Lindner P, Hermansson U. Guided web-based treatment program for reducing cannabis use: a randomized controlled trial. Addict Sci Clin Pract. 2020 Feb 18;15(1):9. doi: 10.1186/s13722-020-00185-8.
Results Reference
derived

Learn more about this trial

Internet-Based Treatment for Individuals With Regular Cannabis Use: A Randomized Controlled Trial

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