Clinical trial NCT05929040: 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
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Keywords: Chemsex
Cognitive mindfulness
Sexual self efficacy
Well-being
Lead sponsor: London Metropolitan University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 29
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Waitlist control. An experimental group and a delayed group over 8 weeks Waitlist controlled RCT (N= 16 immediate group, N=15)
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Changes in Chemsex behaviour, measurements taken at weeks 0, 8 and 12
timeFrame: Measurements taken at weeks 0, 8 and 12
measure: Changes in cognitive mindfulness, measurements taken at weeks 0, 8 and 12.
timeFrame: Measurements taken at weeks 0,8 and 12
measure: Changes in sexual self efficacy, measurements taken at weeks 0, 8 and 12.
timeFrame: Measurements taken at weeks 0, 8 and 12
measure: Changes in wellbeing, measurements taken at weeks 0, 8 and 12.
timeFrame: Measurements taken at weeks 0, 8 and 12
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Samantha Banbury
Study officials:
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