Mindfulness-Based-Cognitive-Intervention for African Caribbean Men With Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

A Preliminary Randomised Controlled Study Online Mindfulness-Based-Cognitive-Intervention for African Caribbean Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05167955
• Other study ID #: LondonMU
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: April 2023
• Source: London Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Behavioral:
• Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy
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.

Locations

Country	Name	City	State
United Kingdom	London Met university	London

Sponsors (1)

Lead Sponsor	Collaborator
London Metropolitan University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (9)

American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders: DSM-5. Washington DC: Author.

Baer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, Walsh E, Duggan D, Williams JM. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008 Sep;15(3):329-42. doi: 10.1177/1073191107313003. Epub 2008 Feb 29. — View Citation

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

Bossio 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. — View Citation

Feldman, G., Hayes, A., Kumar, S., Greeson, J., & Laurenceau, J. P. (2007). Mindfulness and emotion regulation: The development and initial validation of the Cognitive and Affective Mindfulness Scale Revised (CAMS-R). Journal of Psychopathology and Behavioral Assessment, 29(3), 177-190.

Libman E, Rothenberg I, Fichten CS, Amsel R. The SSES-E: a measure of sexual self-efficacy in erectile functioning. J Sex Marital Ther. 1985 Winter;11(4):233-47. doi: 10.1080/00926238508405450. — View Citation

Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6. — View Citation

Rhoden EL, Teloken C, Sogari PR, Vargas Souto CA. The use of the simplified International Index of Erectile Function (IIEF-5) as a diagnostic tool to study the prevalence of erectile dysfunction. Int J Impot Res. 2002 Aug;14(4):245-50. doi: 10.1038/sj.ijir.3900859. — View Citation

Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in baseline in erectile dysfunction on a 5 item questionnaire at 0,4 and 8 weeks	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.	0 baseline 4, and 8 week measurements
Primary	Change in baseline in mindfulness on a 10 item questionnaire at 0, 4,and 8 weeks	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.	0 baseline 4, and 8 week measurements
Primary	Change in baseline in wellbeing on a 7 item questionnaire at 0. 4 and 8 weeks	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.	0 baseline, 4, and 8 week measurements
Primary	Change in baseline in sexual self-efficacy on a 25 item questionnaire at 0, 4, and 8 weeks	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 a =0.88 (high) and for men without erectile difficulties, a =0.62 (low to moderate).	0 baseline, 4,and 8 week measurements