Mindfulness-Based-Cognitive-Intervention for African Caribbean Men With Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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

      Psychoeducation Understanding erectile dysfunction 4.2, 5.1, 5.3, 5.5, 5.6, 9.2 The hot cross
      bun

      Sexual self-efficacy Enjoyable sex 1.2,1.4, 1.9, 2.3, 11.2, 15.3,16.2

      Cognitive reframe/self talk Challenging thoughts associated 4.3, 11.2, 13.2, 15.4 with sexual
      performance

      Behavioural

      Reward and reinforcement Encourage new behaviour coupled 1.2, 1.4, 4.1, 8.1, 8.2 with
      positive feedback 10.7, 10.10, 11.2, 14.4

      Self-care Behaviours which promote physical 10.7, 10.10 mental and emotional well-being

      Self-monitoring Monitor behaviour towards goals 1.1, 1.2, 1.3, 1.4, 1.9, 2.2, 2.3, 2.7

      Mindfulness-based cognitive intervention

      Understanding emotions Recognising and developing emotions 1.2, 3.1, 5.6, 8.1, 11.2 and
      coping strategies 12.4

      Goal setting/smart goals Specific, Measurable, Achievable, 1.1, 1.2, 1.3, 1.4, 1.9,
      2.2,2.3,2.7 Realistic and anchored within a Time Frame.

      Self-directed meditation Creating better awareness of 1.9, 4.1, 6.1,8.1, 11.2,15.2 body, mind
      and breathing

      Body scan Bringing attention and awareness 4.1, 6.1, 8.1, 11.2, 15.2 to different areas of
      the body. Top to toe.

      Mindfulness practices Being aware of the present moment 4.1, 6.1,8.1, 11.2, 12.6 15.2, 16.2

      Mindfulness stretching Mind and body connection 4.1, 6.1, 8.1, 11.2, 12.6, 15.2, 16.2

      Self-compassion Encouraging a positive self-identity 11.2, 13.1, 13.2, 13.4, 13.5
    

Intervention name(s): Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy
Intervention type(s): Behavioral
Intervention description(s): An online mindfulness-based cognitive intervention is used as a proposed treatment intervention for erectile dysfunction among African- Caribbean men based in the United Kingdom.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Randomized controlled waitlist (N= 34 experimental and n=34 waitlist)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sexual wellbeing; mindfulness; sexual self-efficacy