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Completed

NCT Number: NCT05929040

The Use of Cognitive Mindfulness for Chemsex

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.

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Key information

Conditions

Substance Use Behavior Chemically-Induced Disorders Chemsex Mental Disorders Sexual Behavior Substance-Related Disorders

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Samantha Banbury

London, N7 8DB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mindful cognitive intervention

Behavioral

Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy

Primary outcomes

  1. Changes in Chemsex behaviour, measurements taken at weeks 0, 8 and 12

    Time frame: 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.

  2. Changes in cognitive mindfulness, measurements taken at weeks 0, 8 and 12.

    Time frame: 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.

  3. Changes in sexual self efficacy, measurements taken at weeks 0, 8 and 12.

    Time frame: 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..

  4. Changes in wellbeing, measurements taken at weeks 0, 8 and 12.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

London Metropolitan University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 3, 2023
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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