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

NCT05167955 | Completed

• 1 other identifier: LondonMU
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Keywords

sexual wellbeing; mindfulness; sexual self-efficacy

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 α =0.88 (high) and for men without erectile difficulties, α =0.62 (low to moderate).

  0 baseline, 4,and 8 week measurements

Study Arms (2)

Experimental Randomized controlled waitlist

EXPERIMENTAL

n=34 (will receive Mindfulness-based cognitive intervention)

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

Waitlist Randomized controlled waitlist

OTHER

waitlist Randomized controlled waitlist n=34 (will not receive Mindfulness-based cognitive intervention for 1 month)

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

Interventions

Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy BEHAVIORAL

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.

Experimental Randomized controlled waitlist; Waitlist Randomized controlled waitlist

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: African Caribbean men aged 18 years and above with erectile dysfunction
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• London Metropolitan University: lead

Study Sites (1)

London Met university

London, N7 8DB, United Kingdom

Location

Related Publications (9)

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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 30297094 BACKGROUND

• 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.

  PMID: 23512568 BACKGROUND

• 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.

  PMID: 18042300 BACKGROUND

• 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.

  PMID: 18310597 BACKGROUND

• 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.

  PMID: 4078907 BACKGROUND

• 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.

  PMID: 12152112 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Samantha Banbury, PhD

  Reader

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled waitlist (N= 34 experimental and n=34 waitlist)

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 22, 2021
• Study Start: October 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: March 1, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)