Bipolar at risk trial

ISRCTN	ISRCTN10773067
DOI	https://doi.org/10.1186/ISRCTN10773067
Secondary identifying numbers	19040

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

Plain English summary under review

Contact information

Dr Heather Law
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

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a 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 hypothesis	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
Condition	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	Conversion to mania (SCID); Timepoint(s): 6 months, 12 months
Secondary outcome measures	1. Beck Depression Inventory; Timepoint(s): 6 months,12 months 2. EPQ adapted; Timepoint(s): 6 months, 12 months 3. Global Assessment of Functioning scale; Timepoint(s): 6 months, 12 months 4. Health Status (EQ-5D); Timepoint(s): 6 months, 12 months 5. Hypomanic Attitudes and Positive Predictions Inventory; Timepoint(s): 6 months, 12 months 6. Internal States Scale; Timepoint(s): 6 months, 12 months 7. World Health Organisation Quality of Life; Timepoint(s): 6 months,12 months 8. Young Mania Rating Scale; Timepoint(s): 6 months,12 months
Overall study start date	01/06/2015
Overall study end date	01/12/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 76; UK Sample Size: 76; Description: A target recruitment of 76 (38 per condition) would allow for a drop out rate of 20%.
Total final enrolment	76
Participant 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
Participant 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
Recruitment start date	01/06/2015
Recruitment end date	01/12/2016

Locations

Countries of recruitment

England
United Kingdom

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

Sponsor information

Greater Manchester West Mental Health NHS Foundation Trust
Hospital/treatment centre

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

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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?
Other publications	qualitative investigation of participant experiences	16/10/2021	29/10/2021	Yes	No
HRA research summary			28/06/2023	No	No

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.