Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
19040
Study information
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
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
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
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
Reason abandoned (if study stopped)
Eligibility
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 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 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
Funders
Funder type
Government
Funder name
National Institute for Health Research
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
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) Intention to share
No
IPD sharing plan
Not provided at time of registration
IPD sharing plan summary
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 |