The Use of Cognitive Mindfulness for Chemsex

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Substance Use

Intervention / Treatment
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* Behavioral: mindful cognitive intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate group<br>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. | Behavioral: mindful cognitive intervention<br>* Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy<br>|
| Other: Delayed group<br>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. | Behavioral: mindful cognitive intervention<br>* Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Measurements taken at weeks 0, 8 and 12 | 
| 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. | Measurements taken at weeks 0,8 and 12 | 
| 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.. | Measurements taken at weeks 0, 8 and 12 | 
| 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. | Measurements taken at weeks 0, 8 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemsex, Cognitive mindfulness, Sexual self efficacy, Well-being