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The Use of Cognitive Mindfulness for Chemsex

Primary Purpose

Substance Use

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
mindful cognitive intervention
Sponsored by
London Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Substance Use focused on measuring Chemsex, Cognitive mindfulness, Sexual self efficacy, Well-being

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Aged 18 years old and above Are engaged in chemsex Men who have sex with men Can read and write English Had access to a password-protected laptop/computer Registered with a General Practitioner Registered with a health care service supporting substance use/chemsex. Exclusion Criteria: Aged below 18 years old Those who do not engage in Chemsex Are not registered with a General Practitioner Did not have access to a password-protected laptop/computer Are not registered with a health care service supporting substance use/chemsex Have difficulties reading and writing in English

Sites / Locations

  • Samantha Banbury

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Immediate group

Delayed group

Arm Description

Randomized controlled waitlist study Behavioral: Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy An online mindful cognitive intervention is used as a proposed treatment intervention for chemsex among men ho have sex with men in the United Kingdom.

Randomized controlled waitlist study Behavioral: Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy An online mindful cognitive intervention is used as a proposed treatment intervention for chemsex among men who have sex with men in the United Kingdom.

Outcomes

Primary Outcome Measures

Changes in Chemsex behaviour, measurements taken at weeks 0, 8 and 12
There is currenlty no standardised questionnaire on chemsex. This is a 19-item questionnaire with 4 response categories (1=never through to 4= always). Scores ranged between 19 (low chemsex engagement) to 76 (very high chemsex engagement). 19 No Chemsex; 20-34 Low chemsex; 35-50 Moderate chemsex; 51- 66 High chemsex and 67 + very high chemsex. Questions 1-4 includes drug use, 5-7 self-care, 8-10 lifestyle, 11-14 risk behaviour, 15-19 well-being/mental health.
Changes in cognitive mindfulness, measurements taken at weeks 0, 8 and 12.
The Cognitive and Affective Mindfulness Scale-Revised. This is a 10-item measure with four response categories 1= rarely/not at all to 4 = almost always. Higher scores indicate higher levels of mindfulness (range 4-40). Cronbach's alphas ranged between 0.82 and 0.84.
Changes in sexual self efficacy, measurements taken at weeks 0, 8 and 12.
This is a six-item questionnaire which consists of 4 response categories (1=not at all through to 4= very much). Cronbach's alpha ranges between 0.58- 0.74. Questions centre on the self-efficacy for carrying out healthy sexual behaviours including condom use and sexual consent. There is no reverse scoring. Scores range from 6 (little to no self-efficacy) to 24 (high self-efficacy). This will be adapted accordingly… Think about the time you have engaged in chemsex, how confident are you that you could..
Changes in wellbeing, measurements taken at weeks 0, 8 and 12.
This is a positively worded 7 item questionnaires with 5 response categories looking at functioning and feeling aspects of well-being. The response categories include 1=none of the time to 5=all of the time. Cronbach alpha- 0.89-0.91. There is no reverse scoring. Scores range from 7 to 35 where the latter is the highest level of wellbeing.

Secondary Outcome Measures

Full Information

First Posted
June 23, 2023
Last Updated
June 30, 2023
Sponsor
London Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT05929040
Brief Title
The Use of Cognitive Mindfulness for Chemsex
Official Title
Using the Behaviour Change Technique Taxonomy v1 to Conceptualize the Clinical Content of a Preliminary Randomised Controlled Study of an Online Mindfulness-based Cognitive Intervention for Chemsex
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 5, 2022 (Actual)
Primary Completion Date
June 23, 2023 (Actual)
Study Completion Date
June 23, 2023 (Actual)

3. Sponsor/Collaborators

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

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
Title of research: A preliminary RCT of an online mindfulness-based cognitive intervention for Chemsex Research aim: To determine how an online mindfulness-based cognitive intervention, might reduce Chemsex engagement, risky sexual behaviours, sexual self-efficacy and increase overall wellbeing among men who have sex with men. Research intention: If the mindfulness based cognitive intervention reduces Chemsex engagement and risky sexual behaviours and supports sexual and general wellbeing, then we would repeat this study on a larger scale within the National Health Service among men who have sex with other men and who engage in Chemsex. Both academic output and dissemination accordingly. A brief overview of intervention: Chemsex, sometimes coined as Chemfun, is a term used to describe the use of psychoactive substances with the intention of enhancing and/or facilitating the sexual experience/arousal and predominates among gay and bisexual men. Chemsex drugs tend to include, γ-hydroxybutyric acid and congeners, methamphetamine, mephedrone, erectile dysfunction agents, and alkyl nitrites often in combination. A growing body of research has suggested that mindfulness supports minimize drug using behaviors HIV stress and risky sexual behaviours. However, there appears no current mindfulness intervention that has been evidenced for Chemsex. Our intervention is hoped to become part of a multidisciplinary approach in supporting Chemsex which includes a cross-over effect between drugs, sexual well-being, and general wellbeing. Quantitatively, the research is structured so that participants will be randomized to either the experimental or control group (n=20 experimental; n=20 control waitlist). The MBCI for each group is 1 month (4 wks experimental and 4 wks waitlist control). This is followed by a 3-month follow-up to determine the sustainability of this intervention. Qualitatively, participants will be asked approx 8 open-ended feedback questions forming part of 4 groups of 10, at the 3-month follow-up.
Detailed Description
The principal researcher developed an online cognitive mindfulness intervention. The main target in this study was to engage participants with mindfulness exercises whilst improving wellbeing and mindfulness whilst reducing Chemsex use. The main exercises included mindfulness, breathing exercises, relaxation techniques, being mindful of the senses and the body and understanding of the self. This online mindfulness based cognitive intervention contains cognitive, emotional, and behavioural factors and each of the 4 sessions included substance use and sexual behaviour, working with the inner critic and high-risk situations, sex without drugs and sexual identity and psychosexual wellbeing, substance use and self-compassion. Homework exercises were encouraged which consisted of education, training, modelling, and enablement. To expand, education included psychoeducational information on chemsex, sexual wellbeing, and mindfulness along with additional resources. Training provided the instructions on how to go about engaging in these online activities. Modelling provides examples in action such as MSM discussing their experiences of Chemsex including verbal persuasion and challenging negative self-talk, and how to go about doing the exercises, and enablement is aimed at increasing participants capability of engaging in these activities towards wellbeing. This would be further supported by charts, self-monitors, diaries, and journaling. Further, prompts, action plans, and cues were supportive intervention components. Feedback and support along with discussing the educational components, training, modelling and enablement had been addressed throughout the duration of this study. The development of the mindfulness based cognitive intervention has been based on a behavioral change techniques taxonomy. This have been used because the behavioural change techiques taxonomy has been rigorously tested to evidence the effectiveness in support of interventions associated with change behaviour. The 93 behavior change techniques are the active ingredients of behavior change where each intervention is likely to consist of more than one behaviour change technique and serve as having more than one function. In total, the intervention in this study included 15 domains in which 35 out of the 93 behaviour change techniques listed in the behavioural change technique taxonomy were identified. The selection of these domains used a process of triangulation to ensure consistency in mapping the behaviour change techniques to the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use
Keywords
Chemsex, Cognitive mindfulness, Sexual self efficacy, Well-being

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Waitlist control. An experimental group and a delayed group over 8 weeks Waitlist controlled RCT (N= 16 immediate group, N=15)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate group
Arm Type
Experimental
Arm Description
Randomized controlled waitlist study Behavioral: Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy An online mindful cognitive intervention is used as a proposed treatment intervention for chemsex among men ho have sex with men in the United Kingdom.
Arm Title
Delayed group
Arm Type
Other
Arm Description
Randomized controlled waitlist study Behavioral: Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy An online mindful cognitive intervention is used as a proposed treatment intervention for chemsex among men who have sex with men in the United Kingdom.
Intervention Type
Behavioral
Intervention Name(s)
mindful cognitive intervention
Intervention Description
Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy
Primary Outcome Measure Information:
Title
Changes in Chemsex behaviour, measurements taken at weeks 0, 8 and 12
Description
There is currenlty no standardised questionnaire on chemsex. This is a 19-item questionnaire with 4 response categories (1=never through to 4= always). Scores ranged between 19 (low chemsex engagement) to 76 (very high chemsex engagement). 19 No Chemsex; 20-34 Low chemsex; 35-50 Moderate chemsex; 51- 66 High chemsex and 67 + very high chemsex. Questions 1-4 includes drug use, 5-7 self-care, 8-10 lifestyle, 11-14 risk behaviour, 15-19 well-being/mental health.
Time Frame
Measurements taken at weeks 0, 8 and 12
Title
Changes in cognitive mindfulness, measurements taken at weeks 0, 8 and 12.
Description
The Cognitive and Affective Mindfulness Scale-Revised. This is a 10-item measure with four response categories 1= rarely/not at all to 4 = almost always. Higher scores indicate higher levels of mindfulness (range 4-40). Cronbach's alphas ranged between 0.82 and 0.84.
Time Frame
Measurements taken at weeks 0,8 and 12
Title
Changes in sexual self efficacy, measurements taken at weeks 0, 8 and 12.
Description
This is a six-item questionnaire which consists of 4 response categories (1=not at all through to 4= very much). Cronbach's alpha ranges between 0.58- 0.74. Questions centre on the self-efficacy for carrying out healthy sexual behaviours including condom use and sexual consent. There is no reverse scoring. Scores range from 6 (little to no self-efficacy) to 24 (high self-efficacy). This will be adapted accordingly… Think about the time you have engaged in chemsex, how confident are you that you could..
Time Frame
Measurements taken at weeks 0, 8 and 12
Title
Changes in wellbeing, measurements taken at weeks 0, 8 and 12.
Description
This is a positively worded 7 item questionnaires with 5 response categories looking at functioning and feeling aspects of well-being. The response categories include 1=none of the time to 5=all of the time. Cronbach alpha- 0.89-0.91. There is no reverse scoring. Scores range from 7 to 35 where the latter is the highest level of wellbeing.
Time Frame
Measurements taken at weeks 0, 8 and 12

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
men who have sex with men
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 18 years old and above Are engaged in chemsex Men who have sex with men Can read and write English Had access to a password-protected laptop/computer Registered with a General Practitioner Registered with a health care service supporting substance use/chemsex. Exclusion Criteria: Aged below 18 years old Those who do not engage in Chemsex Are not registered with a General Practitioner Did not have access to a password-protected laptop/computer Are not registered with a health care service supporting substance use/chemsex Have difficulties reading and writing in English
Facility Information:
Facility Name
Samantha Banbury
City
London
ZIP/Postal Code
N7 8DB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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20217471
Citation
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The Use of Cognitive Mindfulness for Chemsex

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