Substance UseNCT05929040
The Use of Cognitive Mindfulness for Chemsex
A study testing mindful cognitive intervention in people with Substance Use, run by London Metropolitan University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- mindful cognitive intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Mar 2022to 23 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Substance Use
- Being tested
- mindful cognitive intervention
- Keywords
- Chemsex, Cognitive mindfulness, Sexual self efficacy, Well-being
- Medical subject headings
- Substance-Related Disorders, Chemsex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindful cognitive interventionBehavioural
Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: mindful cognitive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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..
Measured: 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.
Measured: Measurements taken at weeks 0, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start5 Mar 2022
- Primary completion23 Jun 2023
- Study completion23 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samantha Banbury, London Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929040
- Sponsor's protocol ID
- London Met University
- Status last verified
- Jun 2023
- First submitted
- 23 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20217471Flores 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.
PubMed 34218004Baer 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.
PubMed 16443717Banbury, 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
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.
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.
PubMed 33329083Bandura, 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.
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
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.
PubMed 32139497Bossio 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.
PubMed 30297094Bowen 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.
PubMed 24290208Bracchi 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.
PubMed 26372268Cadogan 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.
PubMed 27852287Cane 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.
PubMed 22530986Carrico 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.
PubMed 31860172
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05929040
- Acronym / sponsor ID
- London Met University
- Conditions
- Substance Use
- Keywords
- Chemsex, Cognitive mindfulness, Sexual self efficacy, Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- London Metropolitan UniversityUniversity, hospital or other
- Study start
- 5 Mar 2022 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 23 Jun 2023 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Waitlist control. An experimental group and a delayed group over 8 weeks Waitlist controlled RCT (N= 16 immediate group, N=15)
| Arm | Type | Receives |
|---|---|---|
| Immediate group | Experimental | Behavioral: mindful cognitive interventionRandomized 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. |
| Delayed group | Other | Behavioral: mindful cognitive interventionRandomized 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindful cognitive interventionMindfulness based cognitive intervention based on the behavioural change techniques taxonomy | Behavioural | Delayed group, Immediate group |
Primary outcome
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.
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.
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..
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Results publication: PubMed 20217471Alvy 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.
- Results publication: PubMed 34218004Flores 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.
- Results publication: PubMed 16443717Baer 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.
- Results publicationBanbury, 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
- Results publicationBanbury, 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.
- Results publication: PubMed 33329083Bohn 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.
- Results publicationBandura, 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.
- Results publicationBandura, 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
- Results publication: PubMed 32139497Blomquist 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.
- Results publication: PubMed 30297094Bossio 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.
- Results publication: PubMed 24290208Bowen 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.
- Results publication: PubMed 26372268Bracchi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindful cognitive intervention in people with Substance Use, run by London Metropolitan University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Chemsex behaviour, measurements taken at weeks 0, 8 and 12 (time frame: Measurements taken at weeks 0, 8 and 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05929040, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.