Mental Health IssueNCT05838859
Contraception and Mental Health: Are we Doing Enough?
An observational study of Mental Health Issue and Woman's Health, run by Surrey and Borders Partnership NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The study seeks to determine current practices and perspectives of contraceptive advice of both service users and professionals. It aims to examine 1) the experiences of female service users of reproductive potential with mental health conditions of contraceptive advice from mental health professionals and 2) the… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Woman's Health, Contraception
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Feb 2021to 1 Feb 2025
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This will be a two-armed study sampling service user of childbearing age receiving SABP mental health care services and mental health care professionals. The study will seek to recruit patients from inpatient units and community mental health teams from Surrey and Borders Partnership NHS Foundation and Mental health care professionals from the Trust.
Who may be able to join
- Service Users
- Female aged between 18 and 50 years of age.
- Under SABP mental health services
- Diagnosed DSM IV mental health condition.
- Capacity to give informed consent.
- Professionals
- Doctors, nursing staff Band 6 or above, non-medical prescribers and care- coordinators.
- Employed by Surrey and Borders Partnership NHS Foundation
Who cannot join
- Service Users
- Service users under specialist services such as eating disorders, perinatal services, substance misuse services.
- Service users under Child and Adolescent Mental Health services and Learning Disability Mental Health Services.
- Lacking capacity to consent.
- Under 18 or over 50 years of age
- Service users detained under the Mental Health Act in the inpatient unit or under community treatment order(CTO) in the community.
Show all 9Show fewer
- Professionals
- Mental health professionals not employed by Surrey \& Borders Partnership Foundation NHS Trust
- Mental health professionals not working in Working Age Adult Services.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Surrey and Borders NHS Foundation Trust
Leatherhead, Surrey, KT22 7AD
Olga Balazikova, 01932 722247, olga.balazikova@sabp.nhs.uk
About this study
Official title: Mental Health and Contraception- Are we Doing Enough? A Study Exploring the Current Practice of Providing Contraceptive Advice by Mental Health Professionals and Service User Experience
The study seeks to determine current practices and perspectives of contraceptive advice of both service users and professionals. It aims to examine 1) the experiences of female service users of reproductive potential with mental health conditions of contraceptive advice from mental health professionals and 2) the current practice of providing contraceptive advice by mental health professionals.
Read the detailed description
The WHO Sustainable development goals (SDGs) outline the necessity to ensure universal access to sexual and reproductive healthcare services, including family planning information and education, and the integration of reproductive health into national strategies and programmes. Family planning and contraception knowledge is integral to maintaining or improving relationships for well-being. Whilst contraceptive knowledge is undoubtedly important for all reproductive-aged people, it is of increased importance for women with mental health conditions who are considered a "doubly disadvantaged" group due to their gender and diagnosis.
Women can experience significant reproductive health problems including reduced fertility due to pharmacology use, high rates of unplanned pregnancies, safeguarding processes and increased rate of malformations in their offspring.
NICE (National Institute for Health and Care Excellence) guidelines recommend discussing with women of childbearing potential who have or had mental health problems the use of contraception and any plans of pregnancy, how pregnancy and childbirth might affect a mental health problem and how mental health problem and its treatment might affect the women, the foetus or baby. Although international and national legislation clearly acknowledges equal rights for women with disabilities with regards to family planning, they continue to face challenges in accessing these SRH.
Women who experience severe and persistent mental health issues are more likely to experience unplanned pregnancy, maybe likely to engage in sexual risk taking behaviour and are at a higher risk of sexually transmitted diseases. A recent systematic review estimates that in the UK, at any given time, 9-10% of women will be parents with mental disorder. There are well-established links between parental mental disorder and poor outcomes in children, although not all children are at risk. Throughout the period of foetal development, infancy and toddlerhood the brain of a baby is growing and developing.) These first 1001 days are critical because of optimal brain development and also gives the baby the best possible start in life. People who lack nurture from one or more caring adults in the first 1001 days of their lives achieve less in education and in the world of work; are more likely to behave anti-socially, and are less healthy, physically as well as mentally, than individuals who were given a better start. Furthermore, the harm done to them is likely to be perpetuated in an inter-generational cycle when they have children of their own .
The investigators also looked at some more scientific evidence from the point of view of mental health professionals. Mental health professionals are poor at collecting information regarding the parenting status of their patients and tend not to enquire about children's welfare and needs. In addition, mental health professionals report patients' lack of insight regarding the illness and its impact on children, insufficient knowledge and skills and concerns that discussing parenting and child-related issues might impair the relationship they have with their patient. A research study has found that 16% of childbearing age women were prescribed teratogens. For women with mental health conditions who want to avoid unintended pregnancy, effective contraceptive use can be an important strategy to maintain and even improve health and wellbeing. Barriers in the provision of appropriate reproductive advice includes difficulties in determining "best interests", feeling ill-equipped to discuss sexual and reproductive health due to perceived boundaries and embarrassment, and ethical challenges.
Study Design An observational quantitative cross-sectional design study will be utilised. The investigators will not intervene in any way but simply record the answers to questionnaire of the study participants. All the measurements for the participants will be obtained at a single point in time, although recruitment may take place across a longer period. This is the most suitable method for this study as it minimises loss to follow up, obtrusiveness and response bias and will allow for future replicability and comparisons across other NHS Trusts.
Participants / Population This will be a two-armed study sampling service user of childbearing age receiving SABP mental health care services and mental health care professionals. The study will seek to recruit patients from inpatient units and community mental health teams from Surrey and Borders Partnership NHS Foundation Trust (SABP) and Mental health care professionals from the Trust.
- Conditions
- Mental Health Issue, Woman's Health, Contraception, Family Planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Female service users of childbearing age | Contraception Advice Experiences Survey - using a self-report questionnaire of female service users. | |
| Mental health care professionals | Contraception in Mental Health Survey - self-report questionnaire of professionals' current practices, attitude and knowledge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Service user experience- online survey - designed by investigators
To examine if female service users of childbearing age under the care of mental health services are receiving adequate advice on contraception.
Measured: Sep 2022
Mental health professionals experience - online survey- designed by investigators
To examine the knowledge, practices and attitudes of mental health professionals in providing advice regarding contraception.
Measured: Sep 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start9 Feb 2021
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Surrey and Borders Partnership NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josie Jenkinson, MRCPsych, Principal investigator, Surrey and Borders Partnership NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838859
- Sponsor's protocol ID
- IRAS 284443
- Status last verified
- Apr 2023
- First submitted
- 1 Jun 2022
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010 Jul 16;10:67. doi: 10.1186/1471-2288-10-67.
PubMed 20637084Gee B, Notley C, Byrne R, Clarke T, Hodgekins J, French P, Fowler D. Young people's experiences of Social Recovery Cognitive Behavioural Therapy and treatment as usual in the PRODIGY trial. Early Interv Psychiatry. 2018 Oct;12(5):879-885. doi: 10.1111/eip.12381. Epub 2016 Sep 7.
PubMed 27600941Haslegrave M. Ensuring the inclusion of sexual and reproductive health and rights under a sustainable development goal on health in the post-2015 human rights framework for development. Reprod Health Matters. 2013 Nov;21(42):61-73. doi: 10.1016/S0968-8080(13)42742-8.
PubMed 24315064Henshaw, C & Protti, C (2010) Addressing the sexual and reproductive health needs of women who use mental health services, and Advances in psychiatric treatment Vol 16, 272 - 278.
Howard LM, Megnin-Viggars O, Symington I, Pilling S; Guideline Development Group. Antenatal and postnatal mental health: summary of updated NICE guidance. BMJ. 2014 Dec 18;349:g7394. doi: 10.1136/bmj.g7394. No abstract available.
PubMed 25523903
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health and Contraception- Are we Doing Enough? A Study Exploring the Current Practice of Providing Contraceptive Advice by Mental Health Professionals and Service User Experience
- ClinicalTrials.gov ID
- NCT05838859
- Acronym / sponsor ID
- IRAS 284443
- Conditions
- Mental Health Issue, Woman's Health, Contraception, Family Planning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Surrey and Borders Partnership NHS Foundation TrustUniversity, hospital or other
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 3 May 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.
The study seeks to determine current practices and perspectives of contraceptive advice of both service users and professionals. It aims to examine 1) the experiences of female service users of reproductive potential with mental health conditions of contraceptive advice from mental health professionals and 2) the current practice of providing contraceptive advice by mental health professionals.
Detailed description
The WHO Sustainable development goals (SDGs) outline the necessity to ensure universal access to sexual and reproductive healthcare services, including family planning information and education, and the integration of reproductive health into national strategies and programmes. Family planning and contraception knowledge is integral to maintaining or improving relationships for well-being. Whilst contraceptive knowledge is undoubtedly important for all reproductive-aged people, it is of increased importance for women with mental health conditions who are considered a "doubly disadvantaged" group due to their gender and diagnosis.
Women can experience significant reproductive health problems including reduced fertility due to pharmacology use, high rates of unplanned pregnancies, safeguarding processes and increased rate of malformations in their offspring.
NICE (National Institute for Health and Care Excellence) guidelines recommend discussing with women of childbearing potential who have or had mental health problems the use of contraception and any plans of pregnancy, how pregnancy and childbirth might affect a mental health problem and how mental health problem and its treatment might affect the women, the foetus or baby. Although international and national legislation clearly acknowledges equal rights for women with disabilities with regards to family planning, they continue to face challenges in accessing these SRH.
Women who experience severe and persistent mental health issues are more likely to experience unplanned pregnancy, maybe likely to engage in sexual risk taking behaviour and are at a higher risk of sexually transmitted diseases. A recent systematic review estimates that in the UK, at any given time, 9-10% of women will be parents with mental disorder. There are well-established links between parental mental disorder and poor outcomes in children, although not all children are at risk. Throughout the period of foetal development, infancy and toddlerhood the brain of a baby is growing and developing.) These first 1001 days are critical because of optimal brain development and also gives the baby the best possible start in life. People who lack nurture from one or more caring adults in the first 1001 days of their lives achieve less in education and in the world of work; are more likely to behave anti-socially, and are less healthy, physically as well as mentally, than individuals who were given a better start. Furthermore, the harm done to them is likely to be perpetuated in an inter-generational cycle when they have children of their own .
The investigators also looked at some more scientific evidence from the point of view of mental health professionals. Mental health professionals are poor at collecting information regarding the parenting status of their patients and tend not to enquire about children's welfare and needs. In addition, mental health professionals report patients' lack of insight regarding the illness and its impact on children, insufficient knowledge and skills and concerns that discussing parenting and child-related issues might impair the relationship they have with their patient. A research study has found that 16% of childbearing age women were prescribed teratogens. For women with mental health conditions who want to avoid unintended pregnancy, effective contraceptive use can be an important strategy to maintain and even improve health and wellbeing. Barriers in the provision of appropriate reproductive advice includes difficulties in determining "best interests", feeling ill-equipped to discuss sexual and reproductive health due to perceived boundaries and embarrassment, and ethical challenges.
Study Design An observational quantitative cross-sectional design study will be utilised. The investigators will not intervene in any way but simply record the answers to questionnaire of the study participants. All the measurements for the participants will be obtained at a single point in time, although recruitment may take place across a longer period. This is the most suitable method for this study as it minimises loss to follow up, obtrusiveness and response bias and will allow for future replicability and comparisons across other NHS Trusts.
Participants / Population This will be a two-armed study sampling service user of childbearing age receiving SABP mental health care services and mental health care professionals. The study will seek to recruit patients from inpatient units and community mental health teams from Surrey and Borders Partnership NHS Foundation Trust (SABP) and Mental health care professionals from the Trust.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female service users of childbearing age | – | –Contraception Advice Experiences Survey - using a self-report questionnaire of female service users. |
| Mental health care professionals | – | –Contraception in Mental Health Survey - self-report questionnaire of professionals' current practices, attitude and knowledge |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This will be a two-armed study sampling service user of childbearing age receiving SABP mental health care services and mental health care professionals. The study will seek to recruit patients from inpatient units and community mental health teams from Surrey and Borders Partnership NHS Foundation and Mental health care professionals from the Trust.
Key inclusion criteria (8 listed)
- Service Users
- Female aged between 18 and 50 years of age.
- Under SABP mental health services
- Diagnosed DSM IV mental health condition.
- Capacity to give informed consent.
Key exclusion criteria (9 listed)
- Service Users
- Service users under specialist services such as eating disorders, perinatal services, substance misuse services.
- Service users under Child and Adolescent Mental Health services and Learning Disability Mental Health Services.
- Lacking capacity to consent.
- Under 18 or over 50 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Service user experience- online survey - designed by investigators
Time frame: Sep 2022
To examine if female service users of childbearing age under the care of mental health services are receiving adequate advice on contraception.
Mental health professionals experience - online survey- designed by investigators
Time frame: Sep 2022
To examine the knowledge, practices and attitudes of mental health professionals in providing advice regarding contraception.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Results publication: PubMed 20637084Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010 Jul 16;10:67. doi: 10.1186/1471-2288-10-67.
- Results publication: PubMed 27600941Gee B, Notley C, Byrne R, Clarke T, Hodgekins J, French P, Fowler D. Young people's experiences of Social Recovery Cognitive Behavioural Therapy and treatment as usual in the PRODIGY trial. Early Interv Psychiatry. 2018 Oct;12(5):879-885. doi: 10.1111/eip.12381. Epub 2016 Sep 7.
- Results publication: PubMed 24315064Haslegrave M. Ensuring the inclusion of sexual and reproductive health and rights under a sustainable development goal on health in the post-2015 human rights framework for development. Reprod Health Matters. 2013 Nov;21(42):61-73. doi: 10.1016/S0968-8080(13)42742-8.
- Results publicationHenshaw, C & Protti, C (2010) Addressing the sexual and reproductive health needs of women who use mental health services, and Advances in psychiatric treatment Vol 16, 272 - 278.
- Results publication: PubMed 25523903Howard LM, Megnin-Viggars O, Symington I, Pilling S; Guideline Development Group. Antenatal and postnatal mental health: summary of updated NICE guidance. BMJ. 2014 Dec 18;349:g7394. doi: 10.1136/bmj.g7394. No abstract available.
- 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.
Josie Jenkinson, MRCPsych principal investigator
Surrey and Borders Partnership NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Issue and Woman's Health, run by Surrey and Borders Partnership NHS Foundation Trust 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 8 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: status not confirmed, as of the sponsor's last update on 3 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashma Mohamed, MRCPsych (07766768562, ashma.mohamed@sabp.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Service user experience- online survey - designed by investigators (time frame: Sep 2022). The study lists 2 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 NCT05838859, which also lists 5 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 3 May 2023.