The Use of Cognitive Mindfulness for Chemsex

NCT05929040 | Completed

• 1 other identifier: London Met University
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use

Keywords

Chemsex; Cognitive mindfulness; Sexual self efficacy; Well-being

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Immediate group

EXPERIMENTAL

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

Delayed group

OTHER

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

Interventions

mindful cognitive intervention BEHAVIORAL

Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy

Delayed group; Immediate group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: men who have sex with men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• London Metropolitan University: lead

Study Sites (1)

Samantha Banbury

London, N7 8DB, United Kingdom

Location

Related Publications (24)

• 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.

  PMID: 20217471 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.

  PMID: 34218004 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.

  PMID: 16443717 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

  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.

  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.

  PMID: 33329083 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.

  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

  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.

  PMID: 32139497 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.

  PMID: 30297094 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.

  PMID: 24290208 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.

  PMID: 26372268 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.

  PMID: 27852287 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.

  PMID: 22530986 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.

  PMID: 31860172 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

  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.

  PMID: 31230464 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.

  PMID: 27855594 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.

  PMID: 25689576 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.

  PMID: 15812614 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.

  PMID: 30513473 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.

  PMID: 8993716 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.

  PMID: 18686156 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.

  PMID: 29846139 RESULT

MeSH Terms

Conditions

Substance-Related Disorders; Chemsex

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Sexual Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Samantha Banbury

Model Details: Waitlist control. An experimental group and a delayed group over 8 weeks Waitlist controlled RCT (N= 16 immediate group, N=15)

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 3, 2023
• Study Start: March 5, 2022
• Primary Completion: June 23, 2023
• Study Completion: June 23, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)