Sexual FunctioningNCT06046716
The Impact of Mindful Compassion on Sexual Functioning Post Breast Cancer Treatment
A study testing Mindful compassion based on behavioural change taxonomy experimental group in people with Sexual Functioning, run by London Metropolitan University at 1 site in United Kingdom.
Trial summary
Sexual dysfunction is commonly reported post cancer treatments. Sexual desire and body image are interrelated. Indeed, sexual wellbeing can be affected by diagnosis, medication and cancer treatments which can damage body tissues such as the vagina or penis owing to radiation therapy, or insufficient lubrication caused… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Functioning
- What is being tested?
- Mindful compassion based on behavioural change taxonomy experimental group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2022to 13 Sep 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be registered with a General Practitioner
- Must be registered with a healthcare service which supports post-cancer treatment
- Have sexual desire before cancer diagnosis
- Must be aged 18 years or older
- Must be able to read and write English
- Clinical diagnosis of cancer diagnosis via the National Health Service Services
- The Patient Health Questionnaire screening score would be between minimal to mild, 0-9.
Who cannot join
- Currently receiving cancer treatments
- Completed cancer treatments within six months
- Are not registered with a General Practitioner
- Are not registered with healthcare services providing post-cancer support
- Aged below 18 years old
- Reading and writing English difficulties
Show all 9Show fewer
- Self-perceived low/minimal sexual desire before cancer diagnosis (lifelong)
- A terminal illness/end-of-life
- The Patient Health Questionnaire score range would be between moderate to severe, 10-27.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Preliminary Randomised Clinical Trial Looking at the Impact of State-mindful Self-compassion on Sexual Function Post-breast Cancer Treatments
Sexual dysfunction is commonly reported post cancer treatments. Sexual desire and body image are interrelated. Indeed, sexual wellbeing can be affected by diagnosis, medication and cancer treatments which can damage body tissues such as the vagina or penis owing to radiation therapy, or insufficient lubrication caused by chemotherapy. Additionally, feeling sore, exhausted, anxious, depressed and 'not in the mood' further contribute to changes in sexual desire
Very few evidence-based online interventions have been developed to address sexual difficulties post cancer treatments. This extends to well-being, sexual self efficacy and quality of life. It is imperative that mindful compassion interventions are based on a behavioural taxonomy to support the reliability in the delivery of these interventions. Indeed, this study has set out to identify and describe the key components and behaviour change techniques as part of the online intervention. These have been mapped to a behaviour change taxonomy with the view of supporting standardisation for future trial implementation. Therefore, the aim of this study is to examine the effectiveness of an online mindful-compassion intervention using the 3-system model of emotions based on the behavioural taxonomy among a post cancer treatment group with the view of improving quality of life. The study intends to provide preliminary estimates of pre-post intervention on a waitlist controlled randomised controlled trial looking at sexual self-efficacy, well-being, sexual desire, mindfulness and self-compassion.
Quantitatively, the research is structured so that participants will be randomised to either the active experimental or delayed group. This intervention will be weekly for approximately 1 to 2 hours over 4 weeks. This A follow-up at 12 weeks will be taken to determine the sustainability of this intervention.
Read the detailed description
Psychosocial interventions have varied in supporting post cancer treatments. An intervention gaining momentum in National Health Service practices is mindfulness. Mindfulness can mitigate negative self-thoughts and instead increase wellbeing and sexual self-efficacy which supports sexual functioning. Its applications are diverse and have extended to pre and post cancer treatment interventions. Benefits of mindfulness among post cancer treatment patients include lower levels of anxiety, depression and concerns regarding recurrence.
Mindful compassion is gaining popularity in health care. Mindful compassion consists of mindfulness, humanity, and self-kindness. Mindful compassion has been used in psychosexual services including varied sexual presentation such as sexual pain disorder. Indeed, the three systems model can be used to map out validate and normalise different emotional experiences - as well as map out how they can impact sexual arousal and enjoyment.
The intervention will be delivered by a qualified practitioner specialised in mindful compassion. Participants will be encouraged to engage with at home exercises including sensate, breathing exercises, sexual desire and fantasy diaries, mindfulness and self-compassion exercise including working with body image. This will be guided by the 3-system model of emotions where focus on mind and body will identify physiological changes to a perceived threat, to cognitively identify and attend to internal and external triggers and to incorporate mindful acceptance and compassion to address the critical inner voice. This will be applied to day to day living as well as applying this to sex, intimacy and body image. The foundation of the intervention will be based on a behavioural change taxonomy. This consists of 93 behaviour change techniques taxonomy in which the relevant taxonomies will be selected for this intervention. Table 1 outlines the foundation of the intervention. In total, 12 domains have been included in the development of this intervention. Of these, 20 out of the 93 Behaviour Change Techniques listed in the behaviour change techniques taxonomy were identified.
Table 1
Cognition
Psychosexual education - sex and cancer 1.1, 1.2, 1.3, 1.4 Understanding sexual well-being, efficacy, desire, fantasy and intimacy 1.1, 1.2, 1.3, 1.4, 4.1 Understanding mindful compassion- the threat and drive systems (inner critic) 4.1, 6.1, 7.1, 8.1, 8.7,11.2 Cognitive recognition of the internal and external triggers in relation to threat and drive 2.3, 7.1, 12.1, 13.2, 15.4 Recognition and reframe with acceptance (mind and body- soothing) 13.2, 13.4, 15.2, 15.4, 16.2 Mental rehearsal of fantasy, sensate or sex whether literal or imagery 11.2,15.2, 15.4, 16.2
Behavioural
Self-care Behaviours 3.3, 12.6, 13.1, 13.4 Self-monitoring towards goals 1.1, 1.3, 2.3 Graded tasks towards sensate, sexual fantasy or sexual practice 8.1, 8.7 Restructuring the physical environment (sex furniture, use of porn etc) 12.1 Breathing exercises to minimise distress and increase calmness and safety 8.1, 8.7, 16.2
Self-acceptance/compassion towards feeling soothed and nurtured
Valued self-identity (mind and body) 11.2, 13.1, 13.4 Using sensate to identify body change with acceptance 12.6, 13.1, 13.4 Understanding emotions, feelings and intimacy 3.3, 11.2, 13.1, 13.2, 13.4, 15.2, 15.4, 16.2 Self-directed meditation 4.1, 6.1,8.1, 11.2,15.2 Body scan - better awareness of mind and body (top to toe) 4.1, 6.1, 8.1, 11.2, 15.2 Mindfulness practices and being aware of the present moment 16.2 Mindfulness stretching focusing on mind and body connection 4.1, 6.1, 8.1, 11.2, 15.2 Self-compassion with positive self-identity and sexual embodiment post cancer treatments 11.2, 13.1, 13.2, 13.4, 13.5, 15.3, 15.4
Structuring of intervention (online once a week for 1 to 2 hours)
Week 0 (baseline measurements taken)
Week 1 Introduction - psychosexual education
Week 2 The three-model system of emotions and sexual functioning
Week 3 Sexual intimacy and the inner critic
Week 4 Embracing life and embodied sexuality post-cancer (commencement of the delayed group)
- Conditions
- Sexual Functioning
- Being tested
- Mindful compassion based on behavioural change taxonomy experimental group
- Keywords
- cancer, cancer treatment, wellbeing, sexual self efficacy, quality of life
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful compassion based on behavioural change taxonomy experimental groupBehavioural
Since this is a waitlist control study both groups get the same intervention. This is a mindful compassion intervention which is based on the behavioural change taxonomy techniques to support the reliability of the intervention. This will include sensate, mindful exercises, relaxation and attending to the critical voice. The intervention consists of behavioural, cognitive and mindful compassion constructs.
| Study group | Role | What they receive |
|---|---|---|
| Experimental mindful compassion group | Experimental | Experimental randomised controlled waitlist study The experimental group (n=28) will receive mindful compassion intervention at week 1 and intervention terminates at week 4 Receives: Behavioral: Mindful compassion based on behavioural change taxonomy experimental group |
| Waitlist mindful compassion control group | Other | Experimental randomised controlled waitlist study The delayed group (n=24) will receive mindful compassion intervention at week 4 and intervention terminates at week 8 Receives: Behavioral: Mindful compassion based on behavioural change taxonomy experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Health Questionnaire
Measures levels of depression for inclusion and exclusion criteria. The score ranges between 0 and 27, with a higher score representing higher levels of depression.
Measured: This is taken at week 0
Female Sexual Function Index
This is a 19-item questionnaire on sexual function, including sexual desire, orgasm, lubrication, sexual satisfaction and pain. It has five response categories. Scores include severe 2-7.2, moderate 7.3-14.4, mild to moderate 14.5-21.6, mild 21.7- 28.1 cut-off value, and no female sexual dysfunction 28.2 -36.The lower the score, the higher the level of sexual dysfunction.
Measured: Weeks 0, 4 and 12
Adapted Sexual Self-efficacy Erectile Tool
This is a 15-item questionnaire which focuses on sexual confidence and behaviour change associated with therapy. Participants' responses are measured by a 10-item scale ranging from 1 to 10 with 1 being the lowest level of self-efficacy and 10 is the highest. Scores range from 15 to 150 with higher levels representing higher levels of sexual self-efficacy. There is no reverse scoring.
Measured: Weeks 0, 4 and 12
The Short Warwick-Edinburgh Mental Wellbeing Scale
A 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. There is no reverse scoring. Scores range from 7 to 35 where the latter is the highest level of wellbeing.
Measured: Weeks 0, 4 and 12
The Brunnsviken Brief Quality of Life Scale
An 8-item questionnaire with five response categories looking at satisfaction with self, friends, family and creativity. The total score is calculated by summing the satisfaction ratings and summing the six products for a total score with score range between 0-96.
Measured: Weeks 0,4 and 12
The Self-compassion Scale
This is a 12-item measure with five response categories, 1 = almost never to 5= almost always, with higher scores indicating higher levels of self-compassion. The questionnaire measures self-kindness and self-judgement, common humanity and isolation, and mindfulness and over-identification with painful thoughts and emotions. Scores range between. An estimated score between 1-2.5 for overall self-compassion score indicates low levels of self-compassion. 2.5-3.5 indicates moderate. 3.5-5.0 means high levels of overall self-compassion.
Measured: Weeks 0, 4 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Sep 2022
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Sexual FunctioningStudies 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
- Randomised control waitlist n=28 active experimental group and n=24 waitlist control delayed group
- Masking
- None (open label)
- Enrolment
- 52 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, London Metropolitan Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046716
- Sponsor's protocol ID
- LMU
- Status last verified
- May 2024
- First submitted
- 14 Sep 2023
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23512568Libman 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 4078907Tennant 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 18042300Spector IP, Carey MP, Steinberg L. The sexual desire inventory: development, factor structure, and evidence of reliability. J Sex Marital Ther. 1996 Fall;22(3):175-90. doi: 10.1080/00926239608414655.
PubMed 8880651Tylka TL, Wood-Barcalow NL. The Body Appreciation Scale-2: item refinement and psychometric evaluation. Body Image. 2015 Jan;12:53-67. doi: 10.1016/j.bodyim.2014.09.006. Epub 2014 Oct 21.
PubMed 25462882Feldman, 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 ScaleRevised (CAMS-R). Journal of Psychopathology and Behavioral Assessment, 29(3), 177-190
Neff, K. D. (2003). Development and validation of a scale to measure self-compassion. Self and Identity, 2, 223-250.
Vosper, J., Irons, C., Mackenzie-White, K., Saunders, F., Lewis, R., & Gibson, S. (2021). Introducing compassion focused psychosexual therapy. Sexual and Relationship Therapy, 1-33.
Saunders, F., Vosper, J., Gibson, S., Jamieson, R., Zelin, J., & Barter, J. (2022). Compassion Focused Psychosexual Therapy for Women Who Experience Pain during Sex. OBM Integrative and Complementary Medicine, 7(2), 1-1.
Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
PubMed 21584907Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
PubMed 10782451
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Randomised Clinical Trial Looking at the Impact of State-mindful Self-compassion on Sexual Function Post-breast Cancer Treatments
- ClinicalTrials.gov ID
- NCT06046716
- Acronym / sponsor ID
- LMU
- Conditions
- Sexual Functioning
- Keywords
- cancer, cancer treatment, wellbeing, sexual self efficacy, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- London Metropolitan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 21 Sep 2023 (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.
Sexual dysfunction is commonly reported post cancer treatments. Sexual desire and body image are interrelated. Indeed, sexual wellbeing can be affected by diagnosis, medication and cancer treatments which can damage body tissues such as the vagina or penis owing to radiation therapy, or insufficient lubrication caused by chemotherapy. Additionally, feeling sore, exhausted, anxious, depressed and 'not in the mood' further contribute to changes in sexual desire
Very few evidence-based online interventions have been developed to address sexual difficulties post cancer treatments. This extends to well-being, sexual self efficacy and quality of life. It is imperative that mindful compassion interventions are based on a behavioural taxonomy to support the reliability in the delivery of these interventions. Indeed, this study has set out to identify and describe the key components and behaviour change techniques as part of the online intervention. These have been mapped to a behaviour change taxonomy with the view of supporting standardisation for future trial implementation. Therefore, the aim of this study is to examine the effectiveness of an online mindful-compassion intervention using the 3-system model of emotions based on the behavioural taxonomy among a post cancer treatment group with the view of improving quality of life. The study intends to provide preliminary estimates of pre-post intervention on a waitlist controlled randomised controlled trial looking at sexual self-efficacy, well-being, sexual desire, mindfulness and self-compassion.
Quantitatively, the research is structured so that participants will be randomised to either the active experimental or delayed group. This intervention will be weekly for approximately 1 to 2 hours over 4 weeks. This A follow-up at 12 weeks will be taken to determine the sustainability of this intervention.
Detailed description
Psychosocial interventions have varied in supporting post cancer treatments. An intervention gaining momentum in National Health Service practices is mindfulness. Mindfulness can mitigate negative self-thoughts and instead increase wellbeing and sexual self-efficacy which supports sexual functioning. Its applications are diverse and have extended to pre and post cancer treatment interventions. Benefits of mindfulness among post cancer treatment patients include lower levels of anxiety, depression and concerns regarding recurrence.
Mindful compassion is gaining popularity in health care. Mindful compassion consists of mindfulness, humanity, and self-kindness. Mindful compassion has been used in psychosexual services including varied sexual presentation such as sexual pain disorder. Indeed, the three systems model can be used to map out validate and normalise different emotional experiences - as well as map out how they can impact sexual arousal and enjoyment.
The intervention will be delivered by a qualified practitioner specialised in mindful compassion. Participants will be encouraged to engage with at home exercises including sensate, breathing exercises, sexual desire and fantasy diaries, mindfulness and self-compassion exercise including working with body image. This will be guided by the 3-system model of emotions where focus on mind and body will identify physiological changes to a perceived threat, to cognitively identify and attend to internal and external triggers and to incorporate mindful acceptance and compassion to address the critical inner voice. This will be applied to day to day living as well as applying this to sex, intimacy and body image. The foundation of the intervention will be based on a behavioural change taxonomy. This consists of 93 behaviour change techniques taxonomy in which the relevant taxonomies will be selected for this intervention. Table 1 outlines the foundation of the intervention. In total, 12 domains have been included in the development of this intervention. Of these, 20 out of the 93 Behaviour Change Techniques listed in the behaviour change techniques taxonomy were identified.
Table 1
Cognition
Psychosexual education - sex and cancer 1.1, 1.2, 1.3, 1.4 Understanding sexual well-being, efficacy, desire, fantasy and intimacy 1.1, 1.2, 1.3, 1.4, 4.1 Understanding mindful compassion- the threat and drive systems (inner critic) 4.1, 6.1, 7.1, 8.1, 8.7,11.2 Cognitive recognition of the internal and external triggers in relation to threat and drive 2.3, 7.1, 12.1, 13.2, 15.4 Recognition and reframe with acceptance (mind and body- soothing) 13.2, 13.4, 15.2, 15.4, 16.2 Mental rehearsal of fantasy, sensate or sex whether literal or imagery 11.2,15.2, 15.4, 16.2
Behavioural
Self-care Behaviours 3.3, 12.6, 13.1, 13.4 Self-monitoring towards goals 1.1, 1.3, 2.3 Graded tasks towards sensate, sexual fantasy or sexual practice 8.1, 8.7 Restructuring the physical environment (sex furniture, use of porn etc) 12.1 Breathing exercises to minimise distress and increase calmness and safety 8.1, 8.7, 16.2
Self-acceptance/compassion towards feeling soothed and nurtured
Valued self-identity (mind and body) 11.2, 13.1, 13.4 Using sensate to identify body change with acceptance 12.6, 13.1, 13.4 Understanding emotions, feelings and intimacy 3.3, 11.2, 13.1, 13.2, 13.4, 15.2, 15.4, 16.2 Self-directed meditation 4.1, 6.1,8.1, 11.2,15.2 Body scan - better awareness of mind and body (top to toe) 4.1, 6.1, 8.1, 11.2, 15.2 Mindfulness practices and being aware of the present moment 16.2 Mindfulness stretching focusing on mind and body connection 4.1, 6.1, 8.1, 11.2, 15.2 Self-compassion with positive self-identity and sexual embodiment post cancer treatments 11.2, 13.1, 13.2, 13.4, 13.5, 15.3, 15.4
Structuring of intervention (online once a week for 1 to 2 hours)
Week 0 (baseline measurements taken)
Week 1 Introduction - psychosexual education
Week 2 The three-model system of emotions and sexual functioning
Week 3 Sexual intimacy and the inner critic
Week 4 Embracing life and embodied sexuality post-cancer (commencement of the delayed group)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised control waitlist n=28 active experimental group and n=24 waitlist control delayed group
| Arm | Type | Receives |
|---|---|---|
| Experimental mindful compassion group | Experimental | Behavioral: Mindful compassion based on behavioural change taxonomy experimental groupExperimental randomised controlled waitlist study The experimental group (n=28) will receive mindful compassion intervention at week 1 and intervention terminates at week 4 |
| Waitlist mindful compassion control group | Other | Behavioral: Mindful compassion based on behavioural change taxonomy experimental groupExperimental randomised controlled waitlist study The delayed group (n=24) will receive mindful compassion intervention at week 4 and intervention terminates at week 8 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must be registered with a General Practitioner
- Must be registered with a healthcare service which supports post-cancer treatment
- Have sexual desire before cancer diagnosis
- Must be aged 18 years or older
- Must be able to read and write English
Key exclusion criteria (9 listed)
- Currently receiving cancer treatments
- Completed cancer treatments within six months
- Are not registered with a General Practitioner
- Are not registered with healthcare services providing post-cancer support
- Aged below 18 years old
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 |
|---|---|---|
| Mindful compassion based on behavioural change taxonomy experimental groupSince this is a waitlist control study both groups get the same intervention. This is a mindful compassion intervention which is based on the behavioural change taxonomy techniques to support the reliability of the intervention. This will include sensate, mindful exercises, relaxation and attending to the critical voice. The intervention consists of behavioural, cognitive and mindful compassion constructs. | Behavioural | Experimental mindful compassion group, Waitlist mindful compassion control group |
Primary outcome
Patients Health Questionnaire
Time frame: This is taken at week 0
Measures levels of depression for inclusion and exclusion criteria. The score ranges between 0 and 27, with a higher score representing higher levels of depression.
Female Sexual Function Index
Time frame: Weeks 0, 4 and 12
This is a 19-item questionnaire on sexual function, including sexual desire, orgasm, lubrication, sexual satisfaction and pain. It has five response categories. Scores include severe 2-7.2, moderate 7.3-14.4, mild to moderate 14.5-21.6, mild 21.7- 28.1 cut-off value, and no female sexual dysfunction 28.2 -36.The lower the score, the higher the level of sexual dysfunction.
Adapted Sexual Self-efficacy Erectile Tool
Time frame: Weeks 0, 4 and 12
This is a 15-item questionnaire which focuses on sexual confidence and behaviour change associated with therapy. Participants' responses are measured by a 10-item scale ranging from 1 to 10 with 1 being the lowest level of self-efficacy and 10 is the highest. Scores range from 15 to 150 with higher levels representing higher levels of sexual self-efficacy. There is no reverse scoring.
The Short Warwick-Edinburgh Mental Wellbeing Scale
Time frame: Weeks 0, 4 and 12
A 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. There is no reverse scoring. Scores range from 7 to 35 where the latter is the highest level of wellbeing.
The Brunnsviken Brief Quality of Life Scale
Time frame: Weeks 0,4 and 12
An 8-item questionnaire with five response categories looking at satisfaction with self, friends, family and creativity. The total score is calculated by summing the satisfaction ratings and summing the six products for a total score with score range between 0-96.
The Self-compassion Scale
Time frame: Weeks 0, 4 and 12
This is a 12-item measure with five response categories, 1 = almost never to 5= almost always, with higher scores indicating higher levels of self-compassion. The questionnaire measures self-kindness and self-judgement, common humanity and isolation, and mindfulness and over-identification with painful thoughts and emotions. Scores range between. An estimated score between 1-2.5 for overall self-compassion score indicates low levels of self-compassion. 2.5-3.5 indicates moderate. 3.5-5.0 means high levels of overall self-compassion.
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 23 May 2024.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 8880651Spector IP, Carey MP, Steinberg L. The sexual desire inventory: development, factor structure, and evidence of reliability. J Sex Marital Ther. 1996 Fall;22(3):175-90. doi: 10.1080/00926239608414655.
- Results publication: PubMed 25462882Tylka TL, Wood-Barcalow NL. The Body Appreciation Scale-2: item refinement and psychometric evaluation. Body Image. 2015 Jan;12:53-67. doi: 10.1016/j.bodyim.2014.09.006. Epub 2014 Oct 21.
- Results publicationFeldman, 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 ScaleRevised (CAMS-R). Journal of Psychopathology and Behavioral Assessment, 29(3), 177-190
- Results publicationNeff, K. D. (2003). Development and validation of a scale to measure self-compassion. Self and Identity, 2, 223-250.
- Results publicationVosper, J., Irons, C., Mackenzie-White, K., Saunders, F., Lewis, R., & Gibson, S. (2021). Introducing compassion focused psychosexual therapy. Sexual and Relationship Therapy, 1-33.
- Results publicationSaunders, F., Vosper, J., Gibson, S., Jamieson, R., Zelin, J., & Barter, J. (2022). Compassion Focused Psychosexual Therapy for Women Who Experience Pain during Sex. OBM Integrative and Complementary Medicine, 7(2), 1-1.
- Results publication: PubMed 21584907Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
- Results publication: PubMed 10782451Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
- 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
London Metropolitan Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful compassion based on behavioural change taxonomy experimental group in people with Sexual Functioning, 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 7 inclusion and 9 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 23 May 2024. 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?
Patients Health Questionnaire (time frame: This is taken at week 0). The study lists 6 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 NCT06046716, which also lists 11 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 23 May 2024.