Condition category
Mental and Behavioural Disorders
Date applied
03/02/2016
Date assigned
03/02/2016
Last edited
05/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Ms Becci Strawbridge

ORCID ID

Contact details

Centre for Affective Disorders
Institute of Psychiatry
Psychology & Neuroscience
King's College London
PO72 De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)207 848 5305
becci.strawbridge@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19967

Study information

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

Acronym

CRiB

Study hypothesis

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

London - City Road, and Hampstead, 16/10/2015, ref: 15/LO/1557

Study design

Randomised controlled trial

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 the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

Cognitive Performance is measured at baseline, 12 and 24 weeks.

Secondary outcome measures

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

Overall trial start date

01/04/2015

Overall trial end date

30/11/2017

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60; Description: One group only, in the UK. Of the 60 participants, 30 will be randomised to CRT intervention and 30 will be randomised to the Treatment as Usualarm, where no change to routine clinical care is made.

Participant 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

Recruitment start date

10/02/2016

Recruitment end date

01/06/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College Hospital
Clinical Research Facility Denmark Hill
London
SE5 9RS
United Kingdom

Trial participating centre

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

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Strand
London
WC2R 2LS
United Kingdom

Sponsor type

University/education

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

Planned publication of a study protocol, a paper detailing the primary findings according the study outcomes and a third paper with supplementary results including the prediction of treatment success. All publications will be in indexed, high quality journals and will be available open access.

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.

Intention to publish date

30/06/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27472964

Publication citations

Additional files

Editorial Notes

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.