Study Results
Results pending
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Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
29 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-03-05
Study Completion Date
2023-06-23
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.
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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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.
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.
Conditions
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Substance Use
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
SEQUENTIAL
Waitlist control. An experimental group and a delayed group over 8 weeks Waitlist controlled RCT (N= 16 immediate group, N=15)
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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Immediate group
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.
Group Type
EXPERIMENTAL
mindful cognitive intervention
Intervention Type
BEHAVIORAL
Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy
Delayed group
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.
Group Type
OTHER
mindful cognitive intervention
Intervention Type
BEHAVIORAL
Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy
Interventions
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mindful cognitive intervention
Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy
Intervention Type
BEHAVIORAL
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.
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
100 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
Yes
Sponsors
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London Metropolitan University
OTHER
Sponsor Role
lead
Responsible Party
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Samantha Banbury
Dr Samantha Banbury
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Samantha Banbury
London, , United Kingdom
Site Status
Countries
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United Kingdom
References
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Alvy LM, McKirnan DJ, Mansergh G, Koblin B, Colfax GN, Flores SA, Hudson S; Project MIX Study Group. Depression is associated with sexual risk among men who have sex with men, but is mediated by cognitive escape and self-efficacy. AIDS Behav. 2011 Aug;15(6):1171-9. doi: 10.1007/s10461-010-9678-z.
Reference Type
RESULT
Flores Anato JL, Panagiotoglou D, Greenwald ZR, Trottier C, Vaziri M, Thomas R, Maheu-Giroux M. Chemsex practices and pre-exposure prophylaxis (PrEP) trajectories among individuals consulting for PrEP at a large sexual health clinic in Montreal, Canada (2013-2020). Drug Alcohol Depend. 2021 Sep 1;226:108875. doi: 10.1016/j.drugalcdep.2021.108875. Epub 2021 Jun 25.
Reference Type
RESULT
Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
Reference Type
RESULT
Banbury, S., Moneta, G & Chandler, C (2021) An exploratory study examining the relationship between sexual self efficacy and premature ejaculation mediated by depression, anxiety and sexual fantasy among a British cohort. Sexual and Relationship Therapy, (7), 1-17DOI: 10.1080/14681994.2021.1932796
Reference Type
RESULT
Banbury, S., Lusher, J., Snuggs, S & Chandler, C., (2021). Mindfulness-based therapies for men and women with sexual dysfunction: a systematic review and meta-analysis. Sexual and Relationship Therapy, DOI: 10.1080/14681994.2021.1883578.
Reference Type
RESULT
Bohn A, Sander D, Kohler T, Hees N, Oswald F, Scherbaum N, Deimel D, Schecke H. Chemsex and Mental Health of Men Who Have Sex With Men in Germany. Front Psychiatry. 2020 Nov 4;11:542301. doi: 10.3389/fpsyt.2020.542301. eCollection 2020.
Reference Type
RESULT
Bandura, A. (1992). Exercise of personal agency through the self-efficacy mechanism. In R. Schwarzer (Ed.), Self-efficacy (pp.3-38). Washington DC US: Hemisphere Publishing Corp.
Reference Type
RESULT
Bandura, A., (1997). Self-efficacy: The exercise of control. New York: W. H. Freeman. ISBN 978-0- 7167- 2850-4. ISBN 0-7167-2850-8, OCLC 36074515
Reference Type
RESULT
Blomquist PB, Mohammed H, Mikhail A, Weatherburn P, Reid D, Wayal S, Hughes G, Mercer CH. Characteristics and sexual health service use of MSM engaging in chemsex: results from a large online survey in England. Sex Transm Infect. 2020 Dec;96(8):590-595. doi: 10.1136/sextrans-2019-054345. Epub 2020 Mar 5.
Reference Type
RESULT
Bossio JA, Basson R, Driscoll M, Correia S, Brotto LA. Mindfulness-Based Group Therapy for Men With Situational Erectile Dysfunction: A Mixed-Methods Feasibility Analysis and Pilot Study. J Sex Med. 2018 Oct;15(10):1478-1490. doi: 10.1016/j.jsxm.2018.08.013.
Reference Type
RESULT
Bowen S, Enkema MC. Relationship between dispositional mindfulness and substance use: findings from a clinical sample. Addict Behav. 2014 Mar;39(3):532-7. doi: 10.1016/j.addbeh.2013.10.026. Epub 2013 Oct 29.
Reference Type
RESULT
Bracchi M, Stuart D, Castles R, Khoo S, Back D, Boffito M. Increasing use of 'party drugs' in people living with HIV on antiretrovirals: a concern for patient safety. AIDS. 2015 Aug 24;29(13):1585-92. doi: 10.1097/QAD.0000000000000786.
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RESULT
Cadogan CA, Ryan C, Francis JJ, Gormley GJ, Passmore P, Kerse N, Hughes CM. Development of an intervention to improve appropriate polypharmacy in older people in primary care using a theory-based method. BMC Health Serv Res. 2016 Nov 16;16(1):661. doi: 10.1186/s12913-016-1907-3.
Reference Type
RESULT
Cane J, O'Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012 Apr 24;7:37. doi: 10.1186/1748-5908-7-37.
Reference Type
RESULT
Carrico AW, Neilands TB, Dilworth SE, Evans JL, Gomicronmez W, Jain JP, Gandhi M, Shoptaw S, Horvath KJ, Coffin L, Discepola MV, Andrews R, Woods WJ, Feaster DJ, Moskowitz JT. Randomized controlled trial of a positive affect intervention to reduce HIV viral load among sexual minority men who use methamphetamine. J Int AIDS Soc. 2019 Dec;22(12):e25436. doi: 10.1002/jia2.25436.
Reference Type
RESULT
Chan, K.K.S., Lee, C.W.L., & Mak, W.W.S., (2018). Mindfulness model of stigma resistance among individuals with psychiatric disorders. Mindfulness, 9(5), 1433-1442. http://dx.doi.org/10.1007/s12671- 018-0887-2
Reference Type
RESULT
Dakwar E, Nunes EV, Hart CL, Foltin RW, Mathew SJ, Carpenter KM, Choi CJJ, Basaraba CN, Pavlicova M, Levin FR. A Single Ketamine Infusion Combined With Mindfulness-Based Behavioral Modification to Treat Cocaine Dependence: A Randomized Clinical Trial. Am J Psychiatry. 2019 Nov 1;176(11):923-930. doi: 10.1176/appi.ajp.2019.18101123. Epub 2019 Jun 24.
Reference Type
RESULT
Giorgetti R, Tagliabracci A, Schifano F, Zaami S, Marinelli E, Busardo FP. When "Chems" Meet Sex: A Rising Phenomenon Called "ChemSex". Curr Neuropharmacol. 2017;15(5):762-770. doi: 10.2174/1570159X15666161117151148.
Reference Type
RESULT
Gu J, Strauss C, Bond R, Cavanagh K. How do mindfulness-based cognitive therapy and mindfulness-based stress reduction improve mental health and wellbeing? A systematic review and meta-analysis of mediation studies. Clin Psychol Rev. 2015 Apr;37:1-12. doi: 10.1016/j.cpr.2015.01.006. Epub 2015 Jan 31.
Reference Type
RESULT
Kurtz SP. Post-circuit blues: motivations and consequences of crystal meth use among gay men in Miami. AIDS Behav. 2005 Mar;9(1):63-72. doi: 10.1007/s10461-005-1682-3.
Reference Type
RESULT
Maxwell S, Shahmanesh M, Gafos M. Chemsex behaviours among men who have sex with men: A systematic review of the literature. Int J Drug Policy. 2019 Jan;63:74-89. doi: 10.1016/j.drugpo.2018.11.014. Epub 2018 Dec 1.
Reference Type
RESULT
McKirnan DJ, Ostrow DG, Hope B. Sex, drugs and escape: a psychological model of HIV-risk sexual behaviours. AIDS Care. 1996 Dec;8(6):655-69. doi: 10.1080/09540129650125371.
Reference Type
RESULT
Rostosky SS, Dekhtyar O, Cupp PK, Anderman EM. Sexual self-concept and sexual self-efficacy in adolescents: a possible clue to promoting sexual health? J Sex Res. 2008 Jul-Sep;45(3):277-86. doi: 10.1080/00224490802204480.
Reference Type
RESULT
Tomkins A, George R, Kliner M. Sexualised drug taking among men who have sex with men: a systematic review. Perspect Public Health. 2019 Jan;139(1):23-33. doi: 10.1177/1757913918778872. Epub 2018 May 30.
Reference Type
RESULT
Other Identifiers
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London Met University
Identifier Type: -
Identifier Source: org_study_id
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