Condition category
Mental and Behavioural Disorders
Date applied
26/08/2015
Date assigned
26/08/2015
Last edited
29/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Plain English summary under review

Trial website

Contact information

Type

Scientific

Primary contact

Dr Heather Law

ORCID ID

Contact details

Greater Manchester West Mental Health NHS Foundation Trust
Psychology Department
Prestwich Hospital
Bury New Road
Prestwich
Greater Manchester
M25 3BL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

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

15/NW/0336

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/06/2015

Overall trial end date

01/12/2016

Reason abandoned

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

Patient

Age group

Adult

Gender

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%.

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

United Kingdom

Trial 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

Organisation

Greater Manchester West Mental Health NHS Foundation Trust

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes