Randomised controlled trial investigating therapy for bipolar inter-episode symptoms
Many people with bipolar disorder experience lingering low moods or quick mood changes even when they are not having a major episode of mania or deep depression. Current psychological therapies mostly focus on preventing major relapses, leaving a gap in care for daily, ongoing symptoms. Researchers funded by the National Institute for Health and Care Research (NIHR) have designed a new behavioural therapy to tackle these in-between symptoms. This study checks how practical and helpful the therapy is for 60 adults across the UK. Participants are randomly placed into one of two groups: one receives their usual NHS care, while the other receives usual care plus the new talking therapy. The study lasts 12 months and involves answering questionnaires to track mood and well-being. The findings will help researchers plan a larger clinical trial in the future.
At a glance
What is this study about?
Bipolar disorder involves significant shifts in mood, energy, and activity levels. While treatments often focus on helping people recover from severe highs (mania) or lows (depression), many people find that life between these big episodes is not completely smooth. You might still experience lingering sadness, irritability, or unpredictable mood swings. This can make everyday routines, work, and relationships feel challenging, leaving you feeling like you never quite get back to your baseline.
Right now, the NHS does not have a specific talking therapy focused entirely on managing these everyday, between-episode symptoms. To address this, UK researchers have developed a new behavioural therapy designed to support people when their mood feels unstable or persistently low outside of a crisis.
This project, called the STABILISE study, is a feasibility trial. That means it is a smaller study to see whether the therapy is practical, easy to attend, and acceptable to patients, and whether the study setup works well. The goal is not to give a final verdict on whether the treatment works for everyone, but to gather the vital evidence needed to run a much larger, nationwide trial in the future.
Key takeaways
- Tests a new talking therapy for ongoing mood swings between major bipolar episodes.
- Open to adults with bipolar disorder who are not currently in a major crisis.
- Half of the participants receive the new therapy plus usual care; half receive usual care only.
- The study lasts 12 months and involves completing regular questionnaires.
- Funded by the NIHR to help pave the way for a larger NHS clinical trial.
Who may be eligible?
This study is open to adults aged 18 and older who have a diagnosis of bipolar disorder (such as Bipolar I, Bipolar II, cyclothymia, or other specified bipolar conditions). To take part, you should currently be experiencing mild low mood or noticeable mood swings, but you must not be in the middle of a severe depressive or manic episode.
You will need to be registered with an NHS GP practice in the study area, speak English well enough to fill in questionnaires, and be motivated to attend psychological therapy sessions.
You cannot join if you are already having another talking therapy for bipolar disorder, or if you are dealing with active drug or alcohol dependence that would make taking part difficult. The study is also not suitable for people currently experiencing a mental health crisis that cannot be safely supported in routine outpatient care, or anyone unable to commit to the appointments.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have a formal diagnosis of bipolar disorder or cyclothymia.
- I experience ongoing mild low mood or mood swings between major episodes.
- I am not currently having a severe manic or deep depressive episode.
- I am not currently receiving another talking therapy for bipolar disorder.
- I am registered with a GP in the study area and can attend regular sessions.
What does participation involve?
If you take part, you will be placed by chance (like flipping a coin) into one of two groups. One group will continue with their usual NHS care as normal. The other group will receive their usual care plus sessions of the new behavioural talking therapy. You have an equal 50% chance of being in either group.
You do not need to stop any of your regular medications. Over the course of 12 months, researchers will ask you to fill out several questionnaires at set times to see how you are feeling and functioning. You will need to attend therapy sessions if you are placed in that group, either in person or online, alongside these regular progress check-ins.
Potential risks and benefits
Locations (3)
- The Accept Clinic (university of Exeter)City onlyExeter, England
- Avon and Wiltshire Mental Health Partnership NHS TrustCity onlyBath, England
- Devon Partnership NHS TrustCity onlyExeter, England
Common questions
Will taking part affect my current medication?
No. You will continue to take your prescribed medication and receive your usual NHS care throughout the trial.
Can I choose to have the new therapy?
No. A computer puts people into groups at random so the study remains fair and scientifically accurate. You have a 50% chance of receiving the therapy.
How much does it cost to take part?
Taking part is completely free. The study is funded by the National Institute for Health and Care Research (NIHR).
What happens if I change my mind?
You can leave the study at any point without giving a reason, and your regular NHS treatment will continue exactly as before.
Where do the therapy sessions take place?
The study is based in the UK and sessions may be held at local clinic sites or online, depending on your location and circumstances.
How to find out more
Study Team
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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