A Preliminary Randomised Controlled Study Online Mindfulness-Based-Cognitive-Intervention for African Caribbean Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Change in baseline in erectile dysfunction on a 5 item questionnaire at 0,4 and 8 weeks
研究概览
简要总结
Title of research: A preliminary Randomised Controlled Study online Mindfulness-Based-Intervention for African-Caribbean men with Erectile Dysfunction
Research aim: How an online mindfulness intervention, based on a behavioral health taxonomy, might reduce symptoms of erectile dysfunction and increase sexual well-being among African-Caribbean men in the United Kingdom.
Research intention: If the Mindfulness-based intervention reduces symptoms of erectile dysfunction and increases sexual wellness, then we would repeat this study on a larger scale among Black, Asian, Minority, and Ethnic men via the National Health Service.
A brief overview of intervention: Erectile dysfunction is the inability to achieve or maintain an erection in up to 75 to 100% of sexual attempts, including masturbation and sexual intercourse. It is typically very costly to treat on the National Health Service, using the combination of medication (e.g. Viagra) and psychosexual therapy.
The use of mindfulness in healthcare for varied psychosocial difficulties is gaining popularity. A meta-analysis on mindfulness and sexual dysfunction among men and women. Whilst gender differences were the priority focus of the analysis, it also looked at how well-represented cultural and minority groups were within the existing clinical trials. The review identified no studies relating to Black, Asian, Minority and Ethnic men with erectile dysfunction and mindfulness.
Quantitatively, the research is structured so that participants will be randomized to either the experimental or control group (n=34 experimental; n=34 control waitlist). A 2-month follow-up will be taken to determine the sustainability of this intervention.
详细描述
The principal researcher developed the online mindfulness cognitive intervention. An understanding of the intervention along with educational sessions about erectile dysfunction will be carried out among the team. Part of this programme will involve the research assistants who will overview the implementation of the assessments and pre and post output measurements of the intervention. The mindfulness box will include an array of educational material and cognitive templates on erectile dysfunction and sexual behaviour education. The mindfulness specialist will deliver the intervention. In total, 16 domains have been included in the development of this intervention. Of these, 35 out of the 93 behavioral change techniques taxonomy were identified.
The main targets here are to engage those with mindfulness exercises whilst improving wellbeing and minimizing erectile dysfunction. This will aim to show salience of consequences where feedback will emphasize the positive outcomes of performing the mindfulness-based cognitive intervention. The main exercises include mindfulness, breathing exercises, relaxation techniques, being mindful of the senses and the body, and understanding of the self. Each of the 4 sessions will be between 2-3 hours long where at-home exercises will be encouraged.. Feedback and support along with discussing the educational components, training, modelling and enablement will be addressed throughout. As the content of the randomized controlled study online mindfulness-based cognitive intervention is, the specific intervention targets described in table 1 have included cognitive, emotional, or behavioral factors or a combination of these.
Table 1
Techniques within this Intervention target Behaviour change techniques taxonomy Randomised controlled study
Cognitive
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •African Caribbean men with erectile dysfunction
- •Aged 18 years and above
- •Registered with a general practitioner
排除标准
- •Taking Viagra during the study
- •Aged younger than 18 years
- •Non-African-Caribbean
- •Not registered with a general practitioner
结局指标
主要结局
Change in baseline in erectile dysfunction on a 5 item questionnaire at 0,4 and 8 weeks
时间窗: 0 baseline 4, and 8 week measurements
This consists of 5 questions with 5 response categories measuring erectile functioning, satisfaction and desire for the last 4 weeks. Cronbach alpha= 0.82 to 0.93. The response categories range from 0=no sexual activity to 5=almost always/always. Subscale scoring is divided into 5 areas including sexual activity, sexual intercourse, sexual stimulation, sexual, ejaculation and orgasm. There is no reverse scoring where scores range from 0 to 75, the latter being higher levels of erectile functioning.
Change in baseline in mindfulness on a 10 item questionnaire at 0, 4,and 8 weeks
时间窗: 0 baseline 4, and 8 week measurements
This is a 10-item questionnaire which consists of 5 response categories (1=never or rarely true through to 5= very often/always true). Cronbach's alpha ranges between 0.69-0.76. There are 7 reversed items. Subscale scoring is divided into 5 areas including observing, describing, acting with awareness, non-judging and non-reactivity. Higher scores reflect higher levels of mindfulness endorsement.
Change in baseline in wellbeing on a 7 item questionnaire at 0. 4 and 8 weeks
时间窗: 0 baseline, 4, and 8 week measurements
A positively worded 7 item questionnaire 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.
Change in baseline in sexual self-efficacy on a 25 item questionnaire at 0, 4, and 8 weeks
时间窗: 0 baseline, 4,and 8 week measurements
The Sexual Self-Efficacy Erectile tool is a 25-item questionnaire which focuses on sexual confidence and behaviour change associated with therapy. Participants responses are measured via a 10-item scale ranging from 10 to 100. Here, 10 is the lowest level of self-efficacy and 100 is the highest. There are no reverse questions. The Cronbach's alpha for men with erectile difficulties is α =0.88 (high) and for men without erectile difficulties, α =0.62 (low to moderate).
次要结局
未报告次要终点
研究者
Samantha Banbury
Principal Investigator
London Metropolitan University