Cognitive remediation therapy in bipolar disorder
| ISRCTN | ISRCTN32290525 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32290525 |
| Secondary identifying numbers | 19967 |
- 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
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
Contact information
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 |
|---|---|
| becci.strawbridge@kcl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 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(s) | London - City Road, and Hampstead, 16/10/2015, ref: 15/LO/1557 |
| 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 |
| Primary outcome measure | 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 study start date | 01/04/2015 |
| Overall study end date | 31/03/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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. |
| Total final enrolment | 60 |
| 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 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
- England
- United Kingdom
Study participating centres
Denmark Hill
London
SE5 9RS
United Kingdom
Bridge House
Landor Road
Clapham
London
SW9 9NU
United Kingdom
Sponsor information
University/education
Strand
London
WC2R 2LS
England
United Kingdom
"ROR" |
https://ror.org/0220mzb33 |
|---|
Funders
Funder type
Government
Government organisation / National government
- 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
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/07/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 29/07/2016 | Yes | No | |
| Results article | results | 01/03/2021 | 26/06/2020 | Yes | No |
| Results article | Exploratory study | 01/07/2021 | 10/03/2023 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
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.
