CompletedInterventional

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

Mood swings can be confusing and exhausting, especially when intense highs and lows start to disrupt daily life. This UK trial investigates whether an adapted talking therapy—Cognitive Behavioural Therapy (CBT)—can support young people who show early signs of bipolar disorder. The trial is open to young people aged 16 to 25 who experience noticeable highs and lows or have depression alongside a family history of bipolar disorder. Half of the participants receive their usual NHS care, while the other half receive their usual care plus up to 26 sessions with a qualified therapist. Over 12 months, researchers will track participants' progress through regular check-ins to see if this therapy helps stabilise mood and reduces emotional distress. Taking part is entirely voluntary, and standard NHS treatment continues as normal throughout the study.

At a glance

Status

Completed

Sponsor

Greater Manchester Mental Health NHS Foundation Trust

Enrolment target

338

Start

01 Feb 2023

Estimated completion

31 Jul 2025

Bipolar disorder

What is this study about?

Bipolar disorder is a mental health condition characterised by significant shifts in mood, energy, and activity levels. For many young people, distressing highs and lows begin years before a formal diagnosis is ever made. During this early stage, people may feel unusually energetic, irritable, or deeply sad. Getting support early can make a meaningful difference in helping young people stay well.

This study tests an adapted type of talking therapy called Cognitive Behavioural Therapy for people 'at risk' of bipolar disorder (CBT-BAR). CBT helps people explore how their thoughts, feelings, and behaviours influence one another. In this trial, therapists work with young people to spot early mood changes, build healthy daily routines, and learn practical coping strategies to manage emotional distress.

Researchers are comparing young people who receive CBT alongside their normal NHS care with those who receive normal care alone. By studying a large group across the UK, the team hopes to learn whether early talking therapy can reduce the chance of developing full bipolar disorder and help young people live happier, more stable lives.

Key takeaways

Tests whether CBT talking therapy helps young people manage distressing mood swings.
Open to young people aged 16 to 25 with early signs of bipolar disorder or a family history.
Participants are randomly allocated to receive either CBT plus usual care, or usual care alone.
Therapy involves up to 26 individual sessions with a trained professional.
Involvement lasts 12 months with follow-up reviews at 4, 6, and 12 months.

Who may be eligible?

This trial is for young people aged 16 to 25 who are seeking support for distressing mood changes. You do not need to have a diagnosis of bipolar disorder to take part.

To be eligible, your experiences over the past year should match one of three profiles: periods of unusually high energy or irritable mood lasting at least two days in a row; periods of depression combined with shorter bursts of elevated mood; or periods of depression alongside having an immediate family member (such as a parent or sibling) diagnosed with bipolar disorder.

A researcher will meet with you for an initial assessment to talk through your mood history and see whether the study is a safe and suitable fit for you.

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 between 16 and 25 years old.
I am currently looking for help with distressing mood swings.
I experience periods of unusually high energy, irritable mood, or low mood.
I have either had highs lasting 2+ days, or have low moods and a close family member with bipolar disorder.
I can attend appointments in Manchester, Lancashire, Sheffield, Birmingham, or Norfolk & Suffolk.

Answer every question to see your result.

What does participation involve?

If you take part, you will first meet a researcher to complete a detailed assessment and fill out several questionnaires about your mood and wellbeing. If you join the study, a computer system will randomly place you into one of two groups.

One group will continue with their usual NHS care. The other group will receive their usual care plus up to 26 one-to-one therapy sessions with a clinical psychologist or CBT therapist. The study does not prescribe or change any medications. All participants will have follow-up review appointments with a researcher at 4, 6, and 12 months, meaning your overall involvement lasts for about one year.

Potential risks and benefits

Taking part offers a thorough mental health assessment and regular check-ins over the year, which many participants find reassuring. If you are placed in the therapy group, you will receive specialised talking therapy at no cost. However, therapy cannot guarantee an improvement in your symptoms. The main risk is that talking about personal difficulties or mood swings can sometimes feel tiring or emotionally upsetting. Your normal NHS care will never be disrupted, and you are free to leave the study at any time without giving a reason.

Locations (5)

Prestwich Hospital
Approximate
Manchester, England
Lancashire & South Cumbria NHS Foundation Trust
City only
Preston, England
Norfolk and Suffolk NHS Foundation Trust
City only
Norwich, England
Sheffield Health & Social Care NHS Foundation Trust
City only
Sheffield, England
Birmingham Women's and Children's NHS Foundation Trust
City only
Birmingham, England

Common questions

Do I have to pay to take part in this study?

No. The study is funded by the National Institute for Health and Care Research (NIHR) and all sessions and assessments are completely free.

Will joining the study affect my current NHS treatment?

No. You will continue to receive your usual care from your GP or local mental health team, including any medication you already take.

What happens if I do not get chosen for the therapy sessions?

You will remain in the usual care group and attend check-ins at 4, 6, and 12 months. Your feedback will still provide vital information to help improve future mental health services.

Where is the study taking place?

The trial is running across NHS trusts in five UK areas: Manchester, Lancashire, Sheffield, Birmingham, and Norfolk & Suffolk.

Can I leave the study if I change my mind?

Yes. Participation is voluntary. You can withdraw at any point, and doing so will not affect your relationship with your healthcare team.

How to find out more

Trial Manager

GMMH-BART2@gmmh.nhs.uk +44 (0)161 358 1395 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.