Bipolar at risk trial
| ISRCTN | ISRCTN10773067 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10773067 |
| Protocol serial number | 19040 |
| Sponsor | Greater Manchester West Mental Health NHS Foundation Trust |
| Funder | National Institute for Health Research |
- Submission date
- 26/08/2015
- Registration date
- 26/08/2015
- Last edited
- 29/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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
Plain English summary under review
Contact information
Dr Heather Law
Scientific
Scientific
Greater Manchester West Mental Health NHS Foundation Trust
Psychology Department
Prestwich Hospital
Bury New Road
Prestwich
Greater Manchester
M25 3BL
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Cognitive behavioural therapy in comparison to treatment as usual in adults at high risk of developing bipolar disorder (Bipolar At Risk): a feasibility study |
| Study acronym | BART |
| Study objectives | Bipolar Disorder (BD) affects around 1% of the population. 1.14 million people met criteria for this condition in 2007. The World Health Organisation has identified BD as one of the main reasons for loss of life and health in 15–44 year olds, with a diagnosis of BD increasing the rate of suicide above the general population rate by 20-30 times. There is poor recognition of the disorder, especially in the early stages. People often experience misdiagnosis which causes frustration and disenchantment with services. Misdiagnosis can also lead to incorrect treatment which can make people's difficulties worse. BD also has financial costs; it is thought that the cost of BD in the UK for 2007 was £5.2 billion and likely to rise to £8.2 billion per year by 2026. People who experience symptoms of high and low mood and meet criteria for Bipolar At Risk (BAR) are considered to be at high risk of developing a full episode of BD. If these individuals are detected 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 established throughout England. Extending early intervention to other mental health problems such as BD would be a major step forward in preventing long term problems and their associated distress, disability and financial burden. The importance of developing interventions with a focus on health promotion and preventative interventions has long been recognised. However, evidence is required to test what treatments might best help this group. This study provides an investigation of a specific psychological intervention. This work fits with recent policy developments such as the Improving Access to Psychological Therapies Programme for those with severe and enduring mental illness. |
| Ethics approval(s) | 15/NW/0336 |
| Health condition(s) or problem(s) studied | Topic: Mental Health; Subtopic: Bipolar affective disorder; Disease: Bipolar affective disorder |
| Intervention | The Cognitive Behavioural Therapy (CBT) intervention will use a specific cognitive model of mood swings. The model proposes that people hold a range of extreme and contradictory beliefs concerning their mood and other internal states (e.g. energy levels). The specific interventions are dependent on the individual formulation, but the range of permissible interventions will be described in our manual. Up to 25 sessions will be delivered over the 6 month treatment envelope. Follow Up Length: 12 month(s); Study Entry : Single Randomisation only |
| Intervention type | Other |
| Primary outcome measure(s) |
Conversion to mania (SCID); Timepoint(s): 6 months, 12 months |
| Key secondary outcome measure(s) |
1. Beck Depression Inventory; Timepoint(s): 6 months,12 months |
| Completion date | 01/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 76 |
| Total final enrolment | 76 |
| Key inclusion criteria | 1. Age 16-25 years old 2. Meet criteria for one of the following Bipolar At Risk (BAR) criteria: 2.1. Group I: Subthreshold mania (Young Mania Rating Scale total score between 5 and 15 + elevated mood = 2 + irritability = 2 for at least 4 days) 2.2. Group II: Depression + Cyclothymia: mild depressive symptoms (BDI-II >20 for at least 1 week) + diagnosis of cyclothymic disorder or bipolar disorder NOS as assessed by SCID I 2.3. Group III: Depression + genetic risk: mild depressive symptoms (BDI-II >20 for at least 1 week) + genetic risk (first degree relative with bipolar disorder) 3. Help seeking 4. Competent and willing to provide written, informed consent |
| Key exclusion criteria | 1. Past history of a treated or untreated manic episode or psychosis of one week duration or longer 2. Past treatment with a mood stabiliser for longer than 6 weeks or antipsychotic for 3 weeks (equals 15 mg per week of haloperidol or equivalent) 3. Moderate to severe learning disability 4. Organic brain disorder 5. Non-english speaking (this would prevent the use of standardised assessment instruments) . 6. Inpatient/acute psychiatric care needed 7. Substance dependency |
| Date of first enrolment | 01/06/2015 |
| Date of final enrolment | 01/12/2016 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Greater Manchester West Mental Health NHS Foundation Trust
Psychology Department
Prestwich Hospital
Bury New Road
Prestwich
Manchester
Greater Manchester
M25 3BL
United Kingdom
Prestwich Hospital
Bury New Road
Prestwich
Manchester
Greater Manchester
M25 3BL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | qualitative investigation of participant experiences | 16/10/2021 | 29/10/2021 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
29/10/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
