Erectile Dysfunction Clinical Trial
Official title:
A Preliminary Randomised Controlled Study Online Mindfulness-Based-Cognitive-Intervention for African Caribbean Men
NCT number | NCT05167955 |
Other study ID # | LondonMU |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2022 |
Est. completion date | March 1, 2023 |
Verified date | April 2023 |
Source | London Metropolitan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | London Met university | London |
Lead Sponsor | Collaborator |
---|---|
London Metropolitan University |
United Kingdom,
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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 |
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