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Using Implementation Intentions to Reduce Cannabis Use

Primary Purpose

Cannabis Use

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Volitional help sheet
Sponsored by
University of Manchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cannabis Use focused on measuring Cannabis, Risk reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Frequent cannabis user (at least fortnightly)

Exclusion Criteria:

  • Younger than 18 years of age
  • Infrequent / no cannabis use (less than fortnightly)

Sites / Locations

  • The University of Manchester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control (volitional help sheet)

Intervention (volitional help sheet)

Arm Description

Participants read a brief statement designed to encourage them to reduce their cannabis use ("We want you to plan to reduce your cannabis use"). Participants are presented with a table with two columns and twenty rows. Twenty 'high risk' situations (temptations) are presented in the left hand column and 20 appropriate responses (processes of change) are presented in the right hand column (see Armitage, 2008). Participants are told that identifying situations in which they were tempted to use cannabis and identifying ways to overcome those temptations had been shown to help people change their behaviour and are asked to tick critical situations/appropriate responses that might be useful to them.

Participants read a brief statement designed to encourage them to reduce their cannabis use ("We want you to plan to reduce your cannabis use"). Participants are presented with a table with two columns and twenty rows. Twenty 'high risk' situations (temptations) are presented in the left hand column and 20 appropriate responses (processes of change) are presented in the right hand column (see Armitage, 2008). Participants are told that identifying situations in which they were tempted to use cannabis and identifying ways to overcome those temptations had been shown to help people change their behaviour. Implementation intentions are formed by linking critical situations with appropriate responses by choosing an appropriate response from a drop down menu for each critical situation.

Outcomes

Primary Outcome Measures

Cannabis use reduction (amount)
Self-reported cannabis use -amount of cannabis (weight)
Cannabis use reduction (frequency)
Self-reported cannabis use - frequency of use (days per week)

Secondary Outcome Measures

Self reported habit as measured by the automaticity subscale of the Self-Report Habit Index.
Self-reported habit (e.g., "Using cannabis is something I do automatically: strongly agree - strongly disagree).
Self reported action control as measured by the scale developed by Sniehotta et al (2011)
Self-reported action control (e.g., "During the last week I often had my intention to reduce my cannabis use on my mind: strongly disagree-strongly agree")
Self reported craving as measured by items from the mood and physical symptoms scale (MPSS)
self reported craving

Full Information

First Posted
December 20, 2018
Last Updated
November 5, 2021
Sponsor
University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT03845842
Brief Title
Using Implementation Intentions to Reduce Cannabis Use
Official Title
Randomized Controlled Trial of a Volitional Help Sheet in Cannabis Users
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 14, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will recruit frequent users of cannabis (defined at least fortnightly use) and randomize them either to: (1) form implementation intentions by linking situations in which they are tempted to use cannabis with strategies to avoid using cannabis in those situations by using a volitional help sheet, or (2) to consider the situations in which they are tempted to use cannabis alongside possible strategies to avoid using it as presented in the volitional help sheet but not to form implementation intentions. The effects on self-reported cannabis use will be assessed 1 month post-intervention. Predictors of cannabis reduction will also be examined.
Detailed Description
Design: This study will use questionnaires to assess participants cannabis habits (frequency and amount of use) and then employ planning strategies to help them quit. Follow up questionnaires will be used to ascertain the success of planning on reduction in cannabis use. Sample Size: We plan to recruit a minimum of 60 participants in each condition (120 total) but aim to collect data from as many participants as possible. Recruitment: To participate in this study a person must be over the age of 18 and a frequent user of cannabis. The study will be advertised online on social media platforms. Procedure: Potential participants will follow an online link to a briefing sheet that provides information about the study. The sheet will also inform participants that they do not have to complete the questionnaire and that they can withdraw from the study at any time without giving a reason. Once they have read the briefing sheet and generated their personal identity code, as instructed, they will complete the questionnaire online. A month after the participants have completed the initial questionnaire they will receive a link to a follow-up questionnaire via email. Email addresses will be stored separately to study data and will be destroyed once the follow up phase has completed and their involvement in the study ends. Outcomes and Analysis: The main purpose of this study is to explore the role of planning in encouraging people to reduce cannabis use. Quantitative analysis will be conducted to assess the effects of planning on cannabis use reduction. The investigators expect to find that planning is effective in helping people reduce their use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use
Keywords
Cannabis, Risk reduction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
311 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control (volitional help sheet)
Arm Type
Active Comparator
Arm Description
Participants read a brief statement designed to encourage them to reduce their cannabis use ("We want you to plan to reduce your cannabis use"). Participants are presented with a table with two columns and twenty rows. Twenty 'high risk' situations (temptations) are presented in the left hand column and 20 appropriate responses (processes of change) are presented in the right hand column (see Armitage, 2008). Participants are told that identifying situations in which they were tempted to use cannabis and identifying ways to overcome those temptations had been shown to help people change their behaviour and are asked to tick critical situations/appropriate responses that might be useful to them.
Arm Title
Intervention (volitional help sheet)
Arm Type
Experimental
Arm Description
Participants read a brief statement designed to encourage them to reduce their cannabis use ("We want you to plan to reduce your cannabis use"). Participants are presented with a table with two columns and twenty rows. Twenty 'high risk' situations (temptations) are presented in the left hand column and 20 appropriate responses (processes of change) are presented in the right hand column (see Armitage, 2008). Participants are told that identifying situations in which they were tempted to use cannabis and identifying ways to overcome those temptations had been shown to help people change their behaviour. Implementation intentions are formed by linking critical situations with appropriate responses by choosing an appropriate response from a drop down menu for each critical situation.
Intervention Type
Behavioral
Intervention Name(s)
Volitional help sheet
Intervention Description
Participants are asked to choose from a list of strategies for avoiding cannabis use.
Primary Outcome Measure Information:
Title
Cannabis use reduction (amount)
Description
Self-reported cannabis use -amount of cannabis (weight)
Time Frame
1 month
Title
Cannabis use reduction (frequency)
Description
Self-reported cannabis use - frequency of use (days per week)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Self reported habit as measured by the automaticity subscale of the Self-Report Habit Index.
Description
Self-reported habit (e.g., "Using cannabis is something I do automatically: strongly agree - strongly disagree).
Time Frame
1 month
Title
Self reported action control as measured by the scale developed by Sniehotta et al (2011)
Description
Self-reported action control (e.g., "During the last week I often had my intention to reduce my cannabis use on my mind: strongly disagree-strongly agree")
Time Frame
1 month
Title
Self reported craving as measured by items from the mood and physical symptoms scale (MPSS)
Description
self reported craving
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Frequent cannabis user (at least fortnightly) Exclusion Criteria: Younger than 18 years of age Infrequent / no cannabis use (less than fortnightly)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynsey Gregg, PhD
Organizational Affiliation
The University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Manchester
City
Manchester
ZIP/Postal Code
M13 9PL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16573874
Citation
Sniehotta FF, Nagy G, Scholz U, Schwarzer R. The role of action control in implementing intentions during the first weeks of behaviour change. Br J Soc Psychol. 2006 Mar;45(Pt 1):87-106. doi: 10.1348/014466605X62460.
Results Reference
background
PubMed Identifier
22935297
Citation
Gardner B, Abraham C, Lally P, de Bruijn GJ. Towards parsimony in habit measurement: testing the convergent and predictive validity of an automaticity subscale of the Self-Report Habit Index. Int J Behav Nutr Phys Act. 2012 Aug 30;9:102. doi: 10.1186/1479-5868-9-102.
Results Reference
background
PubMed Identifier
15179542
Citation
West R, Hajek P. Evaluation of the mood and physical symptoms scale (MPSS) to assess cigarette withdrawal. Psychopharmacology (Berl). 2004 Dec;177(1-2):195-9. doi: 10.1007/s00213-004-1923-6. Epub 2004 Jun 4.
Results Reference
background

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Using Implementation Intentions to Reduce Cannabis Use

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