A trial of a new psychological intervention of cognitive behaviour therapy for young people with distressing mood swings

Plain English Summary

Background and study aims
Bipolar disorder (BD) affects around 1-3% of the population. 1.14 million people met the criteria for BD in 2007 and this is expected to rise to 1.23 million by 2026. The World Health Organisation states BD is one of the main reasons for loss of life and health in 15–44-year-olds, and BD increases the rate of suicide above the general population by 20-30 times. It is poorly recognised, especially in the early stages. People often experience misdiagnosis which causes frustration and disengagement with services. This also leads to incorrect treatment which can make peoples’ difficulties worse. BD also has financial costs; the approximate cost of BD in the UK for 2007 was £5.2 billion and this is likely to rise to £8.2 billion per year by 2026.
People who experience symptoms of high and low mood and meet the criteria for Bipolar at Risk (BAR) are at high risk of developing a full episode of BD. If these individuals are identified early, then interventions aimed at reducing these symptoms and associated distress may reduce the chance of a future full-blown episode of BD. Early intervention for psychosis services have been successfully set up throughout England. Extending early intervention to other mental health problems such as BD would be a major step forward in preventing long-term problems, distress, disability and financial costs.
The importance of developing interventions with a focus on health promotion and prevention has long been recognised. A pilot study was carried out to see whether a psychological therapy (cognitive behavioural therapy, CBT) can be given to individuals who meet the criteria for BAR, and whether it could be a potentially useful treatment. It showed that CBT (CBT-BAR) is an acceptable (as shown by feedback from people who took part) and feasible treatment option (as shown by people agreeing to take part and attending the therapy sessions) for people meeting BAR criteria. The study also had promising findings such as improved mood and functioning. Those who took part spoke positively about their experiences and the impact it had on their life.
The researchers will now replicate this study to understand if this therapy works in a larger group of people. The aim of this study is to conduct a large randomized controlled trial (RCT) comparing CBT-BAR to the usual treatment for individuals meeting BAR criteria. Half of the people who agree to take part will be offered CBT and half will not be offered CBT, but their usual treatment will not be affected. This will allow us to see whether CBT is an effective and helpful treatment option for this group. This study would also help to show whether changes which are targeted through CBT-BAR make a difference in peoples’ experiences of distressing mood swings and other outcomes important in the lives of these young people.

Who can participate?
Young people who are aged between 16-25 years and who meet the bipolar at-risk criteria will be eligible to take part. The bipolar at-risk criteria include three different groups of mood swing experiences. The first group are young people who experience elevated mood that lasts at least two consecutive days. The second group are young people who experience hours of elevated mood as well as periods of low mood. The third group are young people who experience episodes of low mood and have a first-degree relative with a diagnosis of bipolar disorder.

What does the study involve?
Young people referred to the study will meet with a researcher and complete a ‘detailed assessment’ to check their experiences meet the criteria for the study, as well as complete different questionnaires. If the person is confirmed as suitable for the study, they will be randomly selected to be offered the CBT-BAR intervention plus their treatment as usual, or they will remain as receiving their treatment as usual alone. If the person is offered the CBT-BAR intervention, they will meet with a clinical psychologist or CBT therapist for up to 26 sessions. They will then be seen by the researcher for follow-up appointments planned for 4, 6 and 12 months after their initial appointment.

What are the possible benefits and risks of participating?
The initial assessment may help to highlight any problems the young person is experiencing. If appropriate, the research team can signpost to other services that may be helpful. For 50% of people in the study, it is hoped that being randomly allocated to receive the CBT-BAR intervention will be helpful. It is possible that the CBT-BAR intervention will improve mental health difficulties, however, this cannot be guaranteed. The information from this study may help improve the treatment of people who have problems related to concerns about mood swings. For all participants, there will be regular appointments throughout the year with a research assistant. Participants from the previous BART study reported that these appointments were helpful. It is also possible that talking about some of these issues during the assessments may be upsetting. Participants will have the opportunity to discuss any concerns they have with the researcher and are free to withdraw from the study at any point without giving a reason. This decision will not affect any care they receive now or in the future.

Where is the study run from?
The study is taking place in five locations around the UK: Manchester, Lancashire, Sheffield, Birmingham, and Norfolk & Suffolk

When is the study starting and how long is it expected to run for?
December 2020 to July 2026

Who is funding the study?
National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation Programme (UK)

Who is the main contact?
Prof. Sophie Parker, Sophie.Parker@gmmh.nhs.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centres

Sponsor information

Greater Manchester Mental Health NHS Foundation Trust
Hospital/treatment centre

Prestwich Hospital
Bury New Road
Prestwich
Manchester
M25 3BL
England
United Kingdom

Phone	+44 (0)1612710076
Email	researchoffice@gmmh.nhs.uk
Website	https://www.gmmh.nhs.uk//
"ROR"	https://ror.org/05sb89p83

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

14/01/2025: The following changes were made:
1. The overall study end date was changed from 31/08/2025 to 31/07/2026.
2. The recruitment end date was changed from 31/12/2024 to 31/07/2025.
04/09/2024: The target number of participants was corrected from 388 to 338.
12/08/2024: Contact details updated.
06/08/2024: The recruitment end date was changed from 31/08/2024 to 31/12/2024.
06/02/2023: Internal review.
12/01/2023: Trial's existence confirmed by the NIHR.