Cognitive remediation therapy in bipolar disorder

ISRCTN	ISRCTN32290525
DOI	https://doi.org/10.1186/ISRCTN32290525
Protocol serial number	19967
Sponsor	King's College London (UK)
Funder	National Institute for Health Research

Submission date: 03/02/2016
Registration date: 03/02/2016
Last edited: 10/03/2023

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

Plain English summary of protocol

Background and study aims
Bipolar disorder, previously known as “manic depression”, is a serious mental illness that involves episodes of depression (extreme lows) and mania (extreme highs) or hypomania (a milder form of mania). BD can be extremely distressing for both sufferers and their loved ones, and is thought to cost the NHS around £340 million every year. The more episodes a person has the more likely they are to relapse and for quality of life to worsen, and so it is important to find new treatments that improve recovery and boost resilience to reduce further episodes. People with bipolar disorder often have difficulty with thinking skills (cognitive function) such as concentration, memory, and planning. These problems are linked with reduced response to treatment, higher relapse rates, and more difficulties in everyday life. Similar problems in people diagnosed with schizophrenia can be helped with cognitive remediation therapy (a type of therapy designed to improve cognitive function), however it is not yet known whether this would be effective in people with bipolar disorder. The aim of this investigate whether a part-computerised version of CRT, is an acceptable treatment option for people with bipolar disorder and whether it can help to improve cognitive function.

Who can participate?
Adults with bipolar I disorder (a form of BD characterized by severe manic episodes) who are not currently experiencing manic or depressive symptoms.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in two-three weekly sessions of CRT which last for around an hour for 12 weeks, alongside their usual treatment. Participants also complete part of the therapy on a computer, so the total therapy time is around 20-40 hours over the 12 weeks. Those in the second group continue with their usual treatment only for the 12 weeks of the study. At the start of the study and then again after 12 and 24 weeks, participants complete a number of tasks involving thinking, concentration and memory to test their cognitive functioning.

What are the possible benefits and risks of participating?
Participants may benefit from an improvement to their cognitive and everyday functioning after taking part in the study. There is a small risk that the therapy may be distressing for some participants or that that it will not work for them. however trained therapists are available to help participants if this happens.

Where is the study run from?
1. Optima mood disorders clinic, Lambeth Hospital (UK)
2. Clinical Research Facility, King's College Hospital (UK)

When is the study starting and how long is it expected to run for?
December 2015 to December 2016

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

Who is the main contact?
Ms Becci Strawbridge
becci.strawbridge@kcl.ac.uk

Contact information

Ms Becci Strawbridge
Public

Centre for Affective Disorders
Institute of Psychiatry, Psychology & Neuroscience
King's College London
PO72 De Crespigny Park
London
SE5 8AF
United Kingdom

Phone	+44 (0)207 848 5305
Email	becci.strawbridge@kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The Cognitive Remediation in Bipolar (CRiB) Study: a feasibility trial of cognitive remediation therapy in people with bipolar disorder versus treatment as usual
Study acronym	CRiB
Study objectives	The aim of this study is to investigate whether cognitive remediation therapy (CRT) is an acceptable treatment and whether it is effective in improving thinking skills and everyday functioning in patients with bipolar disorder.
Ethics approval(s)	London - City Road, and Hampstead, 16/10/2015, ref: 15/LO/1557
Health condition(s) or problem(s) studied	Topic: Mental Health; Subtopic: Bipolar affective disorder; Disease: Bipolar affective disorder
Intervention	Participants are randomly allocated to one of two groups. Intervention group: Intervention group: Participants receive cognitive remediation therapy (CRT) alongside their usual treatment. This involves attending approximately 2 CRT sessions per week (estimated 1 hour each) for 12 weeks, in addition to computerised exercise practice when convenient. Control group: Participants receive their usual treatment only for 12 weeks. All participants attend three assessment sessions, involving completion of cognitive tasks and questionnaires, at baseline, 12 and 24 weeks.
Intervention type	Other
Primary outcome measure(s)	Cognitive Performance is measured at baseline, 12 and 24 weeks.
Key secondary outcome measure(s)	1. Engagement with the intervention is determined at 12 weeks 2. Level of functioning is measured at baseline 12 and 24 weeks 3. Symptom prevention is measured at baseline 12 and 24 weeks
Completion date	31/03/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Total final enrolment	60
Key inclusion criteria	1. Aged 18 to 65 years 2. Confirmed DSMV diagnosis of bipolar I disorder 3. Those who have been in an euthymic state at two timepoints one week apart, defined by scores of <8 on the Hamilton Rating Scale for Depression and Young Mania Rating Scale at both timepoints
Key exclusion criteria	1. Presence of a substantial neurological/neurodevelopmental disorder 2. Current diagnosis of personality disorder 3. Recent involvement with alcohol or substance abuse 4. Aged under 18 or over 65 years old 5. Severe visual or auditory problems 6. Unable to understand verbal and written instructions in English
Date of first enrolment	10/02/2016
Date of final enrolment	01/06/2017

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

King's College Hospital

Clinical Research Facility
Denmark Hill
London
SE5 9RS
United Kingdom

Lambeth Hospital

Optima mood disorders clinic
Bridge House
Landor Road
Clapham
London
SW9 9NU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study is not expected to be made available due to potential issues arising regarding consent and disclosure, identification and anonymity of participants.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2021	26/06/2020	Yes	No
Results article	Exploratory study	01/07/2021	10/03/2023	Yes	No
Protocol article	protocol	29/07/2016		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

10/03/2023: Publication reference added.
26/06/2020: Publication reference and total final enrolment number added.
18/05/2020: The intention to publish date was changed from 31/03/2020 to 01/07/2020.
21/01/2019: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 30/11/2017 to 31/03/2019.
2. The intention to publish date has been changed from 30/06/2018 to 31/03/2020.
05/10/2016: The recruitment end date has been updated from 01/12/2016 to 01/06/2017.
01/08/2016: Publication reference added.
08/02/2016: Verified study information with principal investigator.