A trial of ‘cognitive remediation therapy’ to improve thinking skills and everyday functioning for people with bipolar disorder

Plain English summary of protocol

Background and study aims
Bipolar disorder (BD) is a common, serious condition. Episodes affect mood and energy, fluctuating between very low (depression), high (mania) or a mixture of these (mixed). Effects on work, relationships and quality of life can be devastating, adversely impacting people with BD, those close to them, health and economic systems. The World Health Organisation state that BD is second only to brain injury in the impact it has on ability to work. Disability for many people with BD is caused by “cognitive impairment” -difficulties with thinking skills such as recalling information, attention and planning. Cognitive impairments are a major concern for people with BD even when not in episodes. Treatment currently focuses on short-term mood but these ongoing, disabling difficulties are often overlooked in healthcare, despite directly affecting abilities to function well in daily life. They also affect long-term recovery prospects.

For people with schizophrenia (who have similar cognitive impairments), a psychological therapy – cognitive remediation (CRT) – provides meaningful, longlasting benefits, such that it is now recommended internationally. Recent small trials suggest that CRT could improve the lives of people with BD. In our study with 60 participants, CRT improved cognition and function with benefits remaining 3 months after therapy. The existing studies are promising, but not big enough to confidently show whether CRT is an effective treatment for BD, so we are doing a larger study aiming to show whether CRT is effective at improving everyday and cognitive functioning and indicate what factors are causing any benefits found.

Who can participate?
Adults aged 18 - 65 years with a confirmed diagnosis of bipolar disorder type I or II.

What does the study involve?
We will recruit 250 people from a range of sources (e.g. health services and places in the community) and randomly allocate them to receive 12 weeks of either evidence-based CRT (125 people) or continue usual care without CRT (125 people). We will test their cognitive skills and everyday functioning before and after the 12-week program, then 3 months later. We will compare these two groups to see whether CRT is better than usual treatment at improving everyday (including work-related) and cognitive functioning. To explore what makes the therapy effective, we will also test whether CRT affects peoples’ knowledge about their cognitive skills, stress hormones and mood instability and whether these changes relate to improved functioning. This may help increase future benefits that CRT could provide.

What are the possible benefits and risks of participating?
We do not yet know for certain whether CRT is beneficial for people with bipolar disorder, but participants may find the therapy itself beneficial if they are randomised to receive it. For everyone taking part, it is possible that the cognitive measures taken at research visits will be to some extent frustrating (if they feel that they are not performing well) and/or helpful in identifying their cognitive strengths and weaknesses

Where is the study run from?
King's College London (UK)

When is the study starting and how long is it expected to run for?
December 2021 to May 2026

Public involvement & dissemination
We are working with the charity Bipolar UK and people with BD to help ensure we research CRT in ways most relevant to those affected. The study proposal has been reviewed by people affected by BD and their feedback influenced which measure (functioning) we chose as the main outcome of the trial, other details of the design, and improvements to our language use. Focus groups are also taking place to finalise details and named service users will contribute to study documents as well be in trial steering groups. Our work so far with people affected by BD confirms a keenness for psychological therapies and wish to improve their functioning at work, socially and cognitively (all core parts of our ‘everyday functioning’ outcome measure). Service users will be involved in dissemination via charities and support groups; results will be shared with participants, public media channels, scientific meetings and journals (with articles accessible to all).

Who is funding the study?
National Institute for Health Research (NIHR) (UK).

Who is the main contact?
cribstudy@kcl.ac.uk

Study website

Contact information

Dr Rebecca Strawbridge
Scientific

IoPPN Centre for Affective Disorders
Denmark Hill
London
SE5 8AZ
United Kingdom

ORCID ID	0000-0002-2984-1124
Phone	n/a
Email	becci.strawbridge@kcl.ac.uk

Dr Dimosthenis Tsapekos
Public, Principal Investigator

IoPPN Centre for Affective Disorders
Denmark Hill
London
SE5 8AZ
United Kingdom

ORCID ID	0000-0002-1972-4813
Phone	n/a
Email	dimosthenis.tsapekos@kcl.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centres

Sponsor information

King's College London
University/education

Institute of Psychiatry, Psychology & Neuroscience
Denmark Hill
London
SE5 8AF
England
United Kingdom

Email	affectivedisorders@kcl.ac.uk
Website	http://www.kcl.ac.uk/index.aspx
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

16/06/2024: The overall study end date was changed from 31/12/2025 to 31/05/2026.
11/06/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 30/06/2024 to 30/06/2025.
2. The overall study end date was changed from 31/12/2024 to 31/12/2025.
3. The intention to publish date was changed from 01/06/2025 to 01/06/2026.
16/11/2023: Publication reference added.
13/10/2023: The following changes have been made:
1. Ethics approval, contact details and study website added.
2. The target number of participant was changed from 200 to 250.
3. Newcastle University was added to the study participating centres.
04/05/2022: The following changes have been made:
1. The participant exclusion criteria have been updated.
2. The ethics approval has been added.
15/12/2021: Internal review.
10/12/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).