Clinical trial NCT05167955: Mindfulness-Based-Cognitive-Intervention for African Caribbean Men With Erectile Dysfunction
Official title: A Preliminary Randomised Controlled Study Online Mindfulness-Based-Cognitive-Intervention for African Caribbean Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Keywords: sexual wellbeing
mindfulness
sexual self-efficacy
Lead sponsor: London Metropolitan University
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 68
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Randomized controlled waitlist (N= 34 experimental and n=34 waitlist)
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* African Caribbean men with erectile dysfunction
* Aged 18 years and above
* Registered with a general practitioner

Exclusion Criteria:

* Taking Viagra during the study
* Aged younger than 18 years
* Non-African-Caribbean
* Not registered with a general practitioner

Primary outcomes:
measure: Change in baseline in erectile dysfunction on a 5 item questionnaire at 0,4 and 8 weeks
timeFrame: 0 baseline 4, and 8 week measurements
measure: Change in baseline in mindfulness on a 10 item questionnaire at 0, 4,and 8 weeks
timeFrame: 0 baseline 4, and 8 week measurements
measure: Change in baseline in wellbeing on a 7 item questionnaire at 0. 4 and 8 weeks
timeFrame: 0 baseline, 4, and 8 week measurements
measure: Change in baseline in sexual self-efficacy on a 25 item questionnaire at 0, 4, and 8 weeks
timeFrame: 0 baseline, 4,and 8 week measurements
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: London Met university
Study officials:
affiliation: Reader
name: Samantha Banbury, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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