Clinical Trials Logo

Clinical 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 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05929040
Study type Interventional
Source London Metropolitan University
Contact
Status Completed
Phase N/A
Start date March 5, 2022
Completion date June 23, 2023

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05806840 - Rapid Adaptation to Prevent Drug Use N/A
Recruiting NCT06003725 - Cultural Adaptation of Drug Treatment for DJJ Youth N/A
Recruiting NCT05414344 - A Brief Intervention for Alcohol Users With Interpersonal Trauma N/A
Recruiting NCT05768815 - Optimizing Mental Health for Infants Exposed to Early Adversity: A Comparison of Breaking the Cycle and Maxxine Wright N/A
Completed NCT05606601 - An Online Intervention Addressing Mental Health and Substance Use in University Students N/A
Completed NCT03489434 - Technology-Based Prevention for Adolescents in Primary Care N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Recruiting NCT05899101 - The Impact of Opioid and Cannabis Exposure on Fetal Growth
Completed NCT02990026 - Specialty Mental Health Probation in North Carolina N/A
Not yet recruiting NCT06116266 - Collaborative Care for Polysubstance Use in Primary Care Settings (Co-Care) N/A
Not yet recruiting NCT03249428 - E-Cigarette Inner City RCT N/A
Active, not recruiting NCT03129334 - Preventing Prescription Drug Abuse in Middle School Students N/A
Completed NCT04183400 - Safety Awareness For Empowerment (SAFE): An RCT With Young People Experiencing Homelessness N/A
Completed NCT02112201 - The ProGirls Study N/A
Completed NCT01752998 - Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings N/A
Terminated NCT01661517 - Brief Intervention and Referral to Treatment With Substance Use Disorders in the Emergency Room Setting Phase 0
Completed NCT01511380 - Targeting HIV Risk Behaviors in Juvenile Drug Court-Involved Youth Phase 2
Completed NCT01351454 - Behavioral Depression Treatment for African American HIV-infected Substance Users N/A
Completed NCT01154309 - Group CBT for Depression and AOD Disorders Phase 1
Completed NCT01025674 - Randomized Trial of the Positive Action Program in Chicago Schools and Extension to Grade 8 N/A