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

Cognitive Remediation in Bipolar (CRiB2): a randomised trial assessing efficacy and mechanisms of cognitive remediation therapy compared with usual care

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10362331

Enrollment

250

Registered

2021-12-14

Start date

2022-04-01

Completion date

Unknown

Last updated

2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar disorder Mental and Behavioural Disorders

Interventions

Participants are randomly allocated to one of two groups. Intervention group: Cognitive remediation therapy (CRT) alongside their usual treatment. This involves attending 1-3 CRT sessions per week (e

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Have a confirmed diagnosis of bipolar disorder type I or II. 2. Be aged between 18 and 65 years. 3. Be euthymic (not in a mood episode) for at least 1 month. 4. Be able to use a computerised device (e.g., computer / smartphone).

Exclusion criteria

Exclusion criteria: Current participant exclusion criteria as of 04/05/2022: 1. Substance use diagnosis (abuse or dependence). 2. Risk of suicide. 3. Impairing neurological disorder or MCI. 4. Previous cognitive remediation therapy. 5. Unable to communicate fluently in English. 6. Intellectual disability. 7. Currently undergoing psychological therapy or planning imminent treatment change. 8. Non-provision of UK healthcare professional contact. 9. Unable to travel to one of the research sites on a regular basis over 25 weeks. 10. Unable to provide informed consent to participate. Previous participant exclusion criteria: 1. Substance use diagnosis (abuse or dependence). 2. Risk of suicide. 3. Impairing neurological disorder or MCI. 4. Previous cognitive remediation therapy. 5. Unable to communicate fluently in English. 6. Intellectual disability. 7. Currently undergoing psychological therapy or planning imminent treatment change. 8. Non-provision of UK healthcare professional contact. 9. Unable to provide informed consent to participate.

Design outcomes

Primary

Measure	Time frame
Everyday functioning, assessed using the Functioning Assessment Short Test. This is measured at baseline, 13 and 25 weeks with the primary outcome timepoint as 25 weeks.	—

Secondary

Measure	Time frame
1. Everyday functioning assessed using the FAST at week 13. 2. Cognition (assessed via individual cognitive domains and global cognitive function score) at weeks 13 and 25. NB this is comprised of 8 individual cognitive tests in addition to global score). 3. Participant-rated cognitive complaints (assessed using the Perceived Deficits Questionnaire [PDQ]) at weeks 13 and 25. 4. Participant-defined goal attainment (assessed using the Goal Attainment Scale [GAS]) at weeks 13 and 25. 5. Sleep quality (assessed using the Pittsburgh Sleep Quality Index [PSQI]) at weeks 13 and 25. 6. Health-related quality of life (assessed using the EuroQoL-5 Dimensions [EQ5D]) at weeks 13 and 25. 7. Depressive symptoms (assessed using the Hamilton Depression Rating Scale [HAMD]) at weeks 13 and 25. 8. Manic symptoms (assessed using the Young Mania Rating Scale [YMRS]) at weeks 13 and 25. Mechanistic outcomes: 1. Cortisol secretion (week 13, adjusted for week 0) in association with global cognition (at week 25) between CR+TAU vs TAU groups. 2. Global cognition (as defined above) (at week 13, adjusted for week 0) in association with FAST (at week 25) between CR+TAU vs TAU groups. 3. Metacognitive skills (MAI/Torres' measures) (at week 13, adjusted for week 0) in association with FAST (at week 25) between CR+TAU vs TAU groups. 4. Affect fluctuation (PANAS) (at week 13, adjusted for week 0) in association with FAST (at week 25) between CR+TAU vs TAU groups.	—

Measure

Time frame

1. Everyday functioning assessed using the FAST at week 13. 2. Cognition (assessed via individual cognitive domains and global cognitive function score) at weeks 13 and 25. NB this is comprised of 8 individual cognitive tests in addition to global score). 3. Participant-rated cognitive complaints (assessed using the Perceived Deficits Questionnaire [PDQ]) at weeks 13 and 25. 4. Participant-defined goal attainment (assessed using the Goal Attainment Scale [GAS]) at weeks 13 and 25. 5. Sleep quality (assessed using the Pittsburgh Sleep Quality Index [PSQI]) at weeks 13 and 25. 6. Health-related quality of life (assessed using the EuroQoL-5 Dimensions [EQ5D]) at weeks 13 and 25. 7. Depressive symptoms (assessed using the Hamilton Depression Rating Scale [HAMD]) at weeks 13 and 25. 8. Manic symptoms (assessed using the Young Mania Rating Scale [YMRS]) at weeks 13 and 25. Mechanistic outcomes: 1. Cortisol secretion (week 13, adjusted for week 0) in association with global cognition (at week 25) between CR+TAU vs TAU groups. 2. Global cognition (as defined above) (at week 13, adjusted for week 0) in association with FAST (at week 25) between CR+TAU vs TAU groups. 3. Metacognitive skills (MAI/Torres' measures) (at week 13, adjusted for week 0) in association with FAST (at week 25) between CR+TAU vs TAU groups. 4. Affect fluctuation (PANAS) (at week 13, adjusted for week 0) in association with FAST (at week 25) between CR+TAU vs TAU groups.

—

Countries

England, United Kingdom

Contacts

Public ContactDimosthenis Tsapekos

dimosthenis.tsapekos@kcl.ac.uk

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 29, 2026