Cognitive behavioural therapy in comparison to treatment as usual in young adults at high risk of developing bipolar disorder (Bipolar At Risk): a randomised controlled trial to investigate the efficacy of a treatment approach targeted at key appraisal change: Bipolar At Risk Trial II (BART II)
Abstract Background Research has demonstrated the ability to identify and treat individuals at high risk of developing psychosis. It is possible to use a similar strategy to identify people who have an emergent risk of bipolar disorder (BD). Interventions during the early phase may improve outcomes...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2025-07-01
|
| Series: | BMC Psychiatry |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12888-025-06973-3 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849769400558682112 |
|---|---|
| author | Sophie Parker Lydia Pearson Rebekah Carney Richard P. Bentall Matthew R. Broome Emma Cernis Timothy Clarke Steven Jones Katherine Moran Jonathan Wilson Isabel Coleman Catherine Hewitt Wendy Jones Heather Law Sarah Peters Gemma Shields David Shiers Luke Strachan Anton Strong Judith Watson Chris J. Sutton |
| author_facet | Sophie Parker Lydia Pearson Rebekah Carney Richard P. Bentall Matthew R. Broome Emma Cernis Timothy Clarke Steven Jones Katherine Moran Jonathan Wilson Isabel Coleman Catherine Hewitt Wendy Jones Heather Law Sarah Peters Gemma Shields David Shiers Luke Strachan Anton Strong Judith Watson Chris J. Sutton |
| author_sort | Sophie Parker |
| collection | DOAJ |
| description | Abstract Background Research has demonstrated the ability to identify and treat individuals at high risk of developing psychosis. It is possible to use a similar strategy to identify people who have an emergent risk of bipolar disorder (BD). Interventions during the early phase may improve outcomes and reduce risk of transition. Criteria have been established to identify individuals considered to be at high risk for developing BD, also known as Bipolar At Risk (BAR). Offering a psychological intervention may provide the possibility of prevention. Evaluating efficacy and the mechanisms by which this treatment works is now required. Methods A multicentre, rater-masked randomised controlled trial with two parallel arms will compare cognitive behaviour therapy (CBT) for young people meeting BAR criteria (CBTBAR) + Treatment as Usual (TAU) vs. TAU alone. Participants will be recruited from five National Health Service (NHS) sites in the UK. Outcome and mediational variables will be collected at baseline, 17-weeks (in treatment), 27-weeks (post-CBTBAR /TAU), and 52-weeks. Qualitative work will examine the perceived mechanisms of change and implementation of CBTBAR in the NHS. Discussion Our efficacy hypotheses are CBTBAR + TAU (compared to TAU alone) will lead to improvement in mood swings, a reduction in the likelihood of transition to BD, and improvements to functioning and quality of life. Our mechanistic hypothesis is CBTBAR + TAU causes improvement in mood swings due to the reduction of extreme positive and negative appraisals of internal states which in turn improves subsequent behaviours used to control mood and then internal states. Our trial will explore the perceived mechanism of change via this novel intervention (CBTBAR) and if the approach can be implemented within current services in the UK. Trial registration/Status The trial protocol is registered with ISRCTN (ISRCTN13363197, registered on 25th January 2023). Recruitment started in February 2023 and is ongoing. |
| format | Article |
| id | doaj-art-e8824c6707fb4c00a3e0346ab8410043 |
| institution | DOAJ |
| issn | 1471-244X |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Psychiatry |
| spelling | doaj-art-e8824c6707fb4c00a3e0346ab84100432025-08-20T03:03:25ZengBMCBMC Psychiatry1471-244X2025-07-0125111510.1186/s12888-025-06973-3Cognitive behavioural therapy in comparison to treatment as usual in young adults at high risk of developing bipolar disorder (Bipolar At Risk): a randomised controlled trial to investigate the efficacy of a treatment approach targeted at key appraisal change: Bipolar At Risk Trial II (BART II)Sophie Parker0Lydia Pearson1Rebekah Carney2Richard P. Bentall3Matthew R. Broome4Emma Cernis5Timothy Clarke6Steven Jones7Katherine Moran8Jonathan Wilson9Isabel Coleman10Catherine Hewitt11Wendy Jones12Heather Law13Sarah Peters14Gemma Shields15David Shiers16Luke Strachan17Anton Strong18Judith Watson19Chris J. Sutton20Youth Mental Health Research Unit, Greater Manchester Mental Health NHS Foundation TrustYouth Mental Health Research Unit, Greater Manchester Mental Health NHS Foundation TrustYouth Mental Health Research Unit, Greater Manchester Mental Health NHS Foundation TrustSchool of Psychology, Faculty of Science, University of SheffieldInstitute for Mental Health, School of Psychology, University of BirminghamInstitute for Mental Health, School of Psychology, University of BirminghamChildren and Young People’s Mental Health Service, Norfolk and Suffolk NHS Foundation TrustSpectrum Centre for Mental Health, Lancaster UniversityChildren and Young People’s Mental Health Service, Norfolk and Suffolk NHS Foundation TrustChildren and Young People’s Mental Health Service, Norfolk and Suffolk NHS Foundation TrustYork Trials Unit, University of YorkYork Trials Unit, University of YorkYouth Mental Health Research Unit, Greater Manchester Mental Health NHS Foundation TrustYouth Mental Health Research Unit, Greater Manchester Mental Health NHS Foundation TrustDivision of Psychology and Mental Health, Faculty of Biology, Medicine & Health, University of ManchesterDivision of Psychology and Mental Health, Faculty of Biology, Medicine & Health, University of ManchesterDivision of Psychology and Mental Health, Faculty of Biology, Medicine & Health, University of ManchesterYork Trials Unit, University of YorkYouth Mental Health Research Unit, Greater Manchester Mental Health NHS Foundation TrustYork Trials Unit, University of YorkLancashire Clinical Trials Unit, University of Central LancashireAbstract Background Research has demonstrated the ability to identify and treat individuals at high risk of developing psychosis. It is possible to use a similar strategy to identify people who have an emergent risk of bipolar disorder (BD). Interventions during the early phase may improve outcomes and reduce risk of transition. Criteria have been established to identify individuals considered to be at high risk for developing BD, also known as Bipolar At Risk (BAR). Offering a psychological intervention may provide the possibility of prevention. Evaluating efficacy and the mechanisms by which this treatment works is now required. Methods A multicentre, rater-masked randomised controlled trial with two parallel arms will compare cognitive behaviour therapy (CBT) for young people meeting BAR criteria (CBTBAR) + Treatment as Usual (TAU) vs. TAU alone. Participants will be recruited from five National Health Service (NHS) sites in the UK. Outcome and mediational variables will be collected at baseline, 17-weeks (in treatment), 27-weeks (post-CBTBAR /TAU), and 52-weeks. Qualitative work will examine the perceived mechanisms of change and implementation of CBTBAR in the NHS. Discussion Our efficacy hypotheses are CBTBAR + TAU (compared to TAU alone) will lead to improvement in mood swings, a reduction in the likelihood of transition to BD, and improvements to functioning and quality of life. Our mechanistic hypothesis is CBTBAR + TAU causes improvement in mood swings due to the reduction of extreme positive and negative appraisals of internal states which in turn improves subsequent behaviours used to control mood and then internal states. Our trial will explore the perceived mechanism of change via this novel intervention (CBTBAR) and if the approach can be implemented within current services in the UK. Trial registration/Status The trial protocol is registered with ISRCTN (ISRCTN13363197, registered on 25th January 2023). Recruitment started in February 2023 and is ongoing.https://doi.org/10.1186/s12888-025-06973-3Bipolar at riskBipolar disorderMood swingsEarly interventionEarly detectionCognitive behavioural therapy |
| spellingShingle | Sophie Parker Lydia Pearson Rebekah Carney Richard P. Bentall Matthew R. Broome Emma Cernis Timothy Clarke Steven Jones Katherine Moran Jonathan Wilson Isabel Coleman Catherine Hewitt Wendy Jones Heather Law Sarah Peters Gemma Shields David Shiers Luke Strachan Anton Strong Judith Watson Chris J. Sutton Cognitive behavioural therapy in comparison to treatment as usual in young adults at high risk of developing bipolar disorder (Bipolar At Risk): a randomised controlled trial to investigate the efficacy of a treatment approach targeted at key appraisal change: Bipolar At Risk Trial II (BART II) BMC Psychiatry Bipolar at risk Bipolar disorder Mood swings Early intervention Early detection Cognitive behavioural therapy |
| title | Cognitive behavioural therapy in comparison to treatment as usual in young adults at high risk of developing bipolar disorder (Bipolar At Risk): a randomised controlled trial to investigate the efficacy of a treatment approach targeted at key appraisal change: Bipolar At Risk Trial II (BART II) |
| title_full | Cognitive behavioural therapy in comparison to treatment as usual in young adults at high risk of developing bipolar disorder (Bipolar At Risk): a randomised controlled trial to investigate the efficacy of a treatment approach targeted at key appraisal change: Bipolar At Risk Trial II (BART II) |
| title_fullStr | Cognitive behavioural therapy in comparison to treatment as usual in young adults at high risk of developing bipolar disorder (Bipolar At Risk): a randomised controlled trial to investigate the efficacy of a treatment approach targeted at key appraisal change: Bipolar At Risk Trial II (BART II) |
| title_full_unstemmed | Cognitive behavioural therapy in comparison to treatment as usual in young adults at high risk of developing bipolar disorder (Bipolar At Risk): a randomised controlled trial to investigate the efficacy of a treatment approach targeted at key appraisal change: Bipolar At Risk Trial II (BART II) |
| title_short | Cognitive behavioural therapy in comparison to treatment as usual in young adults at high risk of developing bipolar disorder (Bipolar At Risk): a randomised controlled trial to investigate the efficacy of a treatment approach targeted at key appraisal change: Bipolar At Risk Trial II (BART II) |
| title_sort | cognitive behavioural therapy in comparison to treatment as usual in young adults at high risk of developing bipolar disorder bipolar at risk a randomised controlled trial to investigate the efficacy of a treatment approach targeted at key appraisal change bipolar at risk trial ii bart ii |
| topic | Bipolar at risk Bipolar disorder Mood swings Early intervention Early detection Cognitive behavioural therapy |
| url | https://doi.org/10.1186/s12888-025-06973-3 |
| work_keys_str_mv | AT sophieparker cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii AT lydiapearson cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii AT rebekahcarney cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii AT richardpbentall cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii AT matthewrbroome cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii AT emmacernis cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii AT timothyclarke cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii AT stevenjones cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii AT katherinemoran cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii AT jonathanwilson cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii AT isabelcoleman cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii AT catherinehewitt cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii AT wendyjones cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii AT heatherlaw cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii AT sarahpeters cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii AT gemmashields cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii AT davidshiers cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii AT lukestrachan cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii AT antonstrong cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii AT judithwatson cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii AT chrisjsutton cognitivebehaviouraltherapyincomparisontotreatmentasusualinyoungadultsathighriskofdevelopingbipolardisorderbipolaratriskarandomisedcontrolledtrialtoinvestigatetheefficacyofatreatmentapproachtargetedatkeyappraisalchangebipolaratrisktrialiibartii |