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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Ashma Mohamed, MRCPsych contact

07766768562

ashma.mohamed@sabp.nhs.uk

Ramya Giridhar, MRCPsych contact

07468752058

ramya.giridhar@sabp.nhs.uk

United Kingdom1 site, 1 recruiting
  • Surrey and Borders NHS Foundation Trust

    Leatherhead, Surrey, KT22 7AD

    Olga Balazikova, 01932 722247, olga.balazikova@sabp.nhs.uk

    Recruiting

Other trials in United Kingdom

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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05838859
Study groupRoleWhat they receive
Female service users of childbearing ageContraception Advice Experiences Survey - using a self-report questionnaire of female service users.
Mental health care professionalsContraception 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.

  1. 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

  2. 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.

  1. First posted3 May 2023
  2. Study start9 Feb 2021
  3. Primary completion1 Feb 2025 (estimated)
  4. Study completion1 Feb 2025 (estimated)

Resources

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)
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 20637084
  • Gee 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 27600941
  • Haslegrave 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 24315064
  • Henshaw, 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

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.

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