Erectile DysfunctionNCT05167955
Mindfulness-Based-Cognitive-Intervention for African Caribbean Men With Erectile Dysfunction
A study testing Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy in people with Erectile Dysfunction, run by London Metropolitan University at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2022to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African Caribbean men with erectile dysfunction
- Aged 18 years and above
- Registered with a general practitioner
Who cannot join
- Taking Viagra during the study
- Aged younger than 18 years
- Non-African-Caribbean
- Not registered with a general practitioner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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
- Conditions
- Erectile Dysfunction
- Being tested
- Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy
- Keywords
- sexual wellbeing, mindfulness, sexual self-efficacy
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based cognitive intervention based on the behavioural change techniques taxonomyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Randomized controlled waitlist | Experimental | n=34 (will receive Mindfulness-based cognitive intervention) Receives: 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) Receives: Behavioral: Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 0 baseline, 4,and 8 week measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Oct 2022
- Primary completion1 Jan 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized controlled waitlist (N= 34 experimental and n=34 waitlist)
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samantha Banbury, London Metropolitan University
- Investigators
- Samantha Banbury, PhD, Principal investigator, Reader
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167955
- Sponsor's protocol ID
- LondonMU
- Status last verified
- Apr 2023
- First submitted
- 19 Nov 2021
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders: DSM-5. Washington DC: Author.
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.
PubMed 30297094Michie 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.
PubMed 23512568Tennant 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.
PubMed 18042300Baer 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.
PubMed 18310597Libman 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.
PubMed 4078907Rhoden 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.
PubMed 12152112Feldman, 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Randomised Controlled Study Online Mindfulness-Based-Cognitive-Intervention for African Caribbean Men
- ClinicalTrials.gov ID
- NCT05167955
- Acronym / sponsor ID
- LondonMU
- Conditions
- Erectile Dysfunction
- Keywords
- sexual wellbeing, mindfulness, sexual self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- London Metropolitan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled waitlist (N= 34 experimental and n=34 waitlist)
| Arm | Type | Receives |
|---|---|---|
| Experimental Randomized controlled waitlist | Experimental | Behavioral: Mindfulness based cognitive intervention based on the behavioural change techniques taxonomyn=34 (will receive Mindfulness-based cognitive intervention) |
| Waitlist Randomized controlled waitlist | Other | Behavioral: Mindfulness based cognitive intervention based on the behavioural change techniques taxonomywaitlist Randomized controlled waitlist n=34 (will not receive Mindfulness-based cognitive intervention for 1 month) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- African Caribbean men with erectile dysfunction
- Aged 18 years and above
- Registered with a general practitioner
Key exclusion criteria (4 listed)
- Taking Viagra during the study
- Aged younger than 18 years
- Non-African-Caribbean
- Not registered with a general practitioner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness based cognitive intervention based on the behavioural change techniques taxonomyAn online mindfulness-based cognitive intervention is used as a proposed treatment intervention for erectile dysfunction among African- Caribbean men based in the United Kingdom. | Behavioural | Experimental Randomized controlled waitlist, Waitlist Randomized controlled waitlist |
Primary outcome
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.
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- BackgroundAmerican Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders: DSM-5. Washington DC: Author.
- BackgroundBanbury, 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: PubMed 30297094Bossio 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.
- Background: PubMed 23512568Michie 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.
- Background: PubMed 18042300Tennant 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.
- Background: PubMed 18310597Baer 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.
- Background: PubMed 4078907Libman 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.
- Background: PubMed 12152112Rhoden 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.
- BackgroundFeldman, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samantha Banbury, PhD principal investigator
Reader
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness based cognitive intervention based on the behavioural change techniques taxonomy in people with Erectile Dysfunction, run by London Metropolitan University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05167955, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.