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

April 4, 2023 updated by: Samantha Banbury, London Metropolitan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Randomized controlled waitlist
n=34 (will receive Mindfulness-based cognitive 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.
Other: Waitlist Randomized controlled waitlist
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in baseline in erectile dysfunction on a 5 item questionnaire at 0,4 and 8 weeks
Time Frame: 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.
0 baseline 4, and 8 week measurements
Change in baseline in mindfulness on a 10 item questionnaire at 0, 4,and 8 weeks
Time Frame: 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.
0 baseline 4, and 8 week measurements
Change in baseline in wellbeing on a 7 item questionnaire at 0. 4 and 8 weeks
Time Frame: 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.
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
Time Frame: 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).
0 baseline, 4,and 8 week measurements

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London Metropolitan University

Investigators

  • Principal Investigator: Samantha Banbury, PhD, Reader

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

November 19, 2021

First Submitted That Met QC Criteria

December 20, 2021

First Posted (Actual)

December 22, 2021

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LondonMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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