ISRCTN ISRCTN86380183
DOI https://doi.org/10.1186/ISRCTN86380183
Integrated Research Application System (IRAS) 337057
Central Portfolio Management System (CPMS) 59659
National Institute for Health and Care Research (NIHR) 207571
Sponsor Lancaster University
Funder National Institute for Health and Care Research
Submission date
23/12/2025
Registration date
07/01/2026
Last edited
07/01/2026
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Bipolar disorder is a common severe mental health issue. Many people living with bipolar disorder are parents. The extreme changes in mood which people with bipolar experience can make both parenting and day-to-day life difficult. Often parents with bipolar are cared for by their partners, who are also co-parenting their children. These partner carers experience many emotional and practical impacts, but there is little research on the specific well-being and support needs and experiences of partner carers.

This research aims to understand the needs and experiences of partner carers. Our goal is to find out what needs partner carers have, how they want these needs addressed, and what influences these needs. We will use this information to work with carers and professionals to develop a toolkit to improve social care for these carers.

Who can participate?
Partners of a parent with bipolar, people living with a partner and child with bipolar and parents with bipolar who have at least one child, up to 18 years old, for whom they have parental responsibility.

What does the study involve?
The study will last 21 months and includes three work packages (WP):
WP1: Survey - This will measure well-being, support needs, and experiences with Care Act assessments of 150 partner carers.
WP2: Interviews - We will interview 30 partner carers to gain deeper insights into their experiences
WP3: Toolkit Development - Based on our survey and interview findings, we will co-produce a toolkit for social care workers about the needs of partner carers, working with 10 carers and 10 professionals.

Patient and Public Involvement: A member of our team with lived experience as a carer will lead on coordinating input from partner carers throughout the project. He will form a carer reference group which will meet at the beginning of the study and monthly throughout input into how the study is run and how the results are shared.

Dissemination: The toolkit is a key output, which will help social care workers better support carers of parents with bipolar.

What are the possible benefits and risks of participating?
Participation in the survey may cause some emotional distress, as participants are asked to reflect on the challenges of supporting their partner and on their own mental health. To minimise this risk, survey questions were developed in collaboration with the Carer Reference Group (CRG) members who have lived experience. Based on their feedback, we provided clear explanations for why each question is asked and removed a question relating to carers’ hospitalisation history.
If participants do experience distress, support resources are provided in the participant information sheet, including organisations such as Mind, Bipolar UK, the Samaritans, and NHS 111 for urgent support. Parenting- and caring-specific resources are also included, informed by CRG feedback.
Participants may also experience distress during interviews, as sensitive issues may be discussed. Interviews will be conducted by an experienced researcher who will offer breaks, remind participants that they may choose not to answer any question, and reinforce their right to withdraw at any time. The interview participant information sheet includes the same support resources.
Some participants may find taking part inconvenient or time-consuming, particularly for interviews and workshops. To reduce burden, all study activities will be conducted remotely, the survey will be accessible 24/7, allowing participants to complete it at their own pace. Vouchers will be provided for participation in each work package as a token of appreciation.

Where is the study run from?
Lancaster University, UK.

When is the study starting and how long is it expected to run for?
January 2026 to April 2027

Who is funding the study?
National Institute for Health and Care Research (NIHR), UK.

Who is the main contact?
Prof Stephen Jones, s.jones7@lancaster.ac.uk

Contact information

Prof Steven Jones
Principal investigator

Lancaster University
Health Innovation One
Sir John Fisher Drive
Lancaster
LA1 4AT
United Kingdom

Phone +44 01524593382
Email s.jones7@lancaster.ac.uk
Ms Ragin John
Public, Scientific

Lancashire & South Cumbria NHS Foundation Trust
The Lantern Centre, Vicarage Lane, Fulwood  
Preston
PR2 8DW
United Kingdom

Phone +44 1524 522391
Email Ragin.John@lscft.nhs.uk

Study information

Primary study designObservational
Observational study designA sequential mixed-methods study with a survey, interviews, and co-design workshops
Scientific titleUnderstanding the Wellbeing and Support Needs of Carers of Parents with Bipolar
Study acronymPPB
Study objectivesRationale: This study will explore the social care support needs of partners of parents with BD, in a cost-effective manner, by carrying out the study alongside an existing national project evaluating a digital intervention for parents with bipolar disorder (Integrated Bipolar Parenting Intervention, IBPI: https://www.isrctn.com/ISRCTN15962574). It will benefit from the recruitment infrastructure of the IBPI study with additional recruitment through self-referral and our social care and third sector partners. This work will increase understanding of carers’ wellbeing and support needs (including access to Care Act assessments) as well as the relationships between these and carer sociodemographic and clinical factors. This information will raise awareness of what carers need to help them flourish in these roles and improve social care practice in relation to these individuals.

Aim: The aim of this study is to understand and address the wellbeing and support needs of partner carers of parents with bipolar. Towards this aim, we will pursue the following objectives:

Objectives
Work Package 1 (WP1): Online survey
• To determine levels of and factors associated with carer wellbeing.
• To determine carers’ needs for support including experiences of Care Act assessments.

Work Package 2 (WP2): Qualitative interviews
• To understand in depth the experiences of carers with respect to their wellbeing and support needs and how they intersect.

Work Package 3 (WP3): Co-design
• To create an impactful toolkit on identifying and addressing carers’ needs for frontline social care workers.

Outcomes
WP1 will address these objectives using survey methodology and a combination of bespoke questions and standardised questionnaires.
WP2 will address this aim through semi-structured qualitative interviews sampled for diversity of carer experience from participants in WP1.
WP3 will address this objective through coproduction and implementation of a toolkit informed by WP1 and 2.
Ethics approval(s)

Approved 01/12/2025, East Midlands - Leicester South Research Ethics Committee (2 Redman Place, Stratford, London, E20 1J, United Kingdom; +44 0207 1048310; leicestersouth.rec@hra.nhs.uk), ref: 25/EM/0245

Health condition(s) or problem(s) studied• Partner of a parent with bipolar
• Living with partner and child
• Parent with bipolar has at least one child, up to 18 years old, for whom they have parental responsibility.
InterventionWe will use both a quantitative survey and qualitative interviews to explore rates of use and experiences of carer’s
assessments, as well as support needs and wellbeing.
Survey:
Our recruitment target for the survey is 150 participants.
Participants will complete the survey online. It will be developed and hosted on the online survey software REDCap (Research Electronic Data Capture), which the research team has used previously an ongoing trial (IBPI trial). It will be
a cross-sectional survey, so participants will complete the survey once. The survey has been designed with our Carer Reference Group to ensure it is focussed on relevant factors to them, and that it is written in accessible language.

The survey includes questions on social demographic information of the carer and their family, including the carer’s age, gender, ethnicity, education, geographical location, and duration of caring. The survey will also ask about their partner’s and their child’s sociodemographic information, including age, gender, ethnicity and diagnoses and recent healthcare usage. These questions will be included to help characterise the sample, which will be used during interview sampling, as well as to explore the relationships between these factors and experiences of wellbeing, depression, and anxiety. The survey also includes questions on knowledge and experiences of Carer’s assessments. These questions will explore whether participants know what a carer’s assessment is and how to access one, and whether they have had one. If so, questions will ask to what extent it met their needs for support and their satisfaction with the process. Overall, this will help us to understand the proportion of this group who are accessing these assessments and what impact they have had. The survey will also include standardised measures of wellbeing, anxiety (GAD-7), depression (PHQ-8) and carer wellbeing and support. Using standardised measures will help us to compare this sample with other groups from other research. There will be questions on what support the participant feels they need, with open-ended response textboxes. Responses to these questions can be explored further during the interview and toolkit development.

Finally, there will opportunity for the participant to consent to being invited to an interview and/or to the co-design workshops, or to request not to be contacted. Participants will also be able to opt-in to receiving a summary of the results after the study
finishes.

Interviews:
Our recruitment target for the interviews is 30 participants.
Participants will take part in interviews over phone or via video call, depending on their preference. The interviews are expected to last up to an hour, and will be recorded using an encrypted voice recorder. The research assistant (RA), who will be employed by Lancashire and South Cumbria NHS Foundation Trust, will be experienced in interviewing. They will prepare for these interviews by conducting practice interviews with other members of the research team, and with a member of the carer reference group. The RA will conduct the interviews in a semi-structured manner, using a topic guide but allowing participants to explore specific areas of importance to them. The topic guide will be co-developed with the Carer Reference Group, and will be informed by participant responses to the survey.

Co-design workshops
Our recruitment target for the workshops are 10 partners of parents with bipolar, and 10 social care workers. Each group will meet over five 2-hour sessions to co-design a resource for social care workers, providing guidance for supporting the partners of people with bipolar. Each session will be held online through video conferencing software.
Intervention typeOther
Primary outcome measure(s)
  1. Carer wellbeing and support needs measured using survey, interview at a single timepoint
Key secondary outcome measure(s)
  1. Wellbeing, anxiety, depression, carer wellbeing and support and loneliness measured using standardised measures of wellbeing (Warwick-Edinburgh Mental Wellbeing Scale), anxiety (GAD-7; Generalised Anxiety Disorder 7-item), depression (PHQ-8; Patient Health Questionnaire depression scale), carer wellbeing and support (Carer Wellbeing and Support Measure), and loneliness (using the ONS-recommended UCLA Loneliness Scale and a Direct Loneliness Question from the Community Life Survey) at a single timepoint
Completion date30/04/2027

Eligibility

Participant type(s)
Age groupMixed
Lower age limit18 Years
Upper age limit100 Years
SexAll
Target sample size at registration150
Key inclusion criteria1. Age >= 18 years
2. Partner of a parent with bipolar
3. Living with partner and child
4. Parent with bipolar has at least one child, up to 18 years old, for whom they have parental responsibility.
5. Living in the UK
Key exclusion criteria1. Live outside of the UK.
2. Live separately from their partner or child.
3. Do not understand written English.
4. Do not have computer literacy skills required to complete the online questionnaire.
Date of first enrolment09/01/2026
Date of final enrolment27/02/2027

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Lancashire and South Cumbria NHS Foundation Trust
LSCFT HQ, Sceptre Point, Sceptre Way
Walton Summit, Bamber Bridge
Preston
PR5 6AW
England

Results and Publications

Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
IPD sharing planThe datasets generated during the current study will be stored in a publicly available repository (Lancaster University Research Directory (Pure Portal: https://portal.lancaster.ac.uk/ask/pure/)).

Survey data: The anonymised .csv survey dataset and codebook will be stored on the Lancaster University PURE repository for a minimum of 10 years. This will be available for research purposes under controlled access, after approval from the CI or delegated individual.

Interview transcripts: The anonymised survey transcripts in .docx format will be archived on the Lancaster University PURE repository but will be a closed dataset due to the potentially identifying nature of the narratives. A collection of quotes from the interviews will also be stored on PURE and will be available on request with approval from the CI or delegated individual.

Co-design workshop filed noted: The anonymised fieldnotes from the codesign sessions will also be stored on PURE and will be available on request with approval from the CI or delegated individual.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version 1.1 06/11/2025 05/01/2026 No No

Additional files

48724_PROTOCOL_V1.1_06Nov2025.docx
Protocol file

Editorial Notes

23/12/2025: Study's existence confirmed by Health Research Authority (HRA) (UK)