A randomised controlled trial to investigate the clinical effectiveness and cost effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for depressed non-responders to Increasing Access to Psychological Therapies (IAPT) high-intensity therapies: study protocol
Abstract Background Major depression represents a pressing challenge for health care. In England, Increasing Access to Psychological Therapies (IAPT) services provide evidence-based psychological therapies in a stepped-care approach to patients with depression. While introduction of these services h...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-01-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06882-w |
| _version_ | 1797945739533352960 |
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| author | Thorsten Barnhofer Barnaby D. Dunn Clara Strauss Florian Ruths Barbara Barrett Mary Ryan Asha Ladwa Frances Stafford Roberta Fichera Hannah Baber Ailis McGuinness Isabella Metcalfe Delilah Harding Sarah Walker Poushali Ganguli Shelley Rhodes Allan Young Fiona Warren |
| author_facet | Thorsten Barnhofer Barnaby D. Dunn Clara Strauss Florian Ruths Barbara Barrett Mary Ryan Asha Ladwa Frances Stafford Roberta Fichera Hannah Baber Ailis McGuinness Isabella Metcalfe Delilah Harding Sarah Walker Poushali Ganguli Shelley Rhodes Allan Young Fiona Warren |
| author_sort | Thorsten Barnhofer |
| collection | DOAJ |
| description | Abstract Background Major depression represents a pressing challenge for health care. In England, Increasing Access to Psychological Therapies (IAPT) services provide evidence-based psychological therapies in a stepped-care approach to patients with depression. While introduction of these services has successfully increased access to therapy, estimates suggest that about 50% of depressed patients who have come to the end of the IAPT pathway still show significant levels of symptoms. This study will investigate whether Mindfulness-Based Cognitive Therapy (MBCT), a group intervention combining training in mindfulness meditation and elements from cognitive therapy, can have beneficial effects in depressed patients who have not responded to high-intensity therapy in IAPT. It will seek to establish the effectiveness and cost-effectiveness of MBCT as compared to the treatment these patients would usually receive. Methods In a 2-arm randomised controlled trial, patients who currently meet the criteria for major depressive disorder and who have not sufficiently responded to at least 12 sessions of IAPT high-intensity therapy will be allocated, at a ratio of 1:1, to receive either MBCT (in addition to treatment as usual [TAU]) or continue with TAU only. Assessments will take place at baseline, 10 weeks and 34 weeks post-randomisation. The primary outcome will be reduction in depression symptomatology 34 weeks post-randomisation as assessed using the Public Health Questionnaire-9 (PHQ-9). Secondary outcomes will include depressive symptomatology at 10 weeks post-randomisation and other clinical outcomes measured at 10-week and 34-week follow-up, along with a series of binarised outcomes to indicate clinically significant and reliable change. Evaluations of cost-effectiveness will be based on assessments of service use costs collected using the Adult Service Use Schedule and health utilities derived from the EQ-5D. Discussion This trial will add to the evidence base for the use of MBCT in depressed treatment non-responders. It will constitute the first trial to test MBCT following non-response to psychological therapy, with results providing a direct estimate of efficacy within the IAPT pathway. As such, its results will offer an important basis for decisions regarding the adoption of MBCT for non-responders within IAPT. Trial registration ClinicalTrials.gov NCT05236959. Registered on 11 February 2022. ISRCTN 17755571. Registered on 2 February 2021. |
| first_indexed | 2024-04-10T20:59:53Z |
| format | Article |
| id | doaj.art-6b4e3b5db25848ac8075a899959f6426 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-10T20:59:53Z |
| publishDate | 2023-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-6b4e3b5db25848ac8075a899959f64262023-01-22T12:24:18ZengBMCTrials1745-62152023-01-0124111810.1186/s13063-022-06882-wA randomised controlled trial to investigate the clinical effectiveness and cost effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for depressed non-responders to Increasing Access to Psychological Therapies (IAPT) high-intensity therapies: study protocolThorsten Barnhofer0Barnaby D. Dunn1Clara Strauss2Florian Ruths3Barbara Barrett4Mary Ryan5Asha Ladwa6Frances Stafford7Roberta Fichera8Hannah Baber9Ailis McGuinness10Isabella Metcalfe11Delilah Harding12Sarah Walker13Poushali Ganguli14Shelley Rhodes15Allan Young16Fiona Warren17School of Psychology, University of SurreyDepartment of Psychology, University of ExeterUniversity of SussexSouth London and Maudsley NHS Foundation TrustKing’s Health Economics, King’s College LondonDepartment of Health and Social Care Innovation Lab, Southbank UniversityDepartment of Psychology, University of ExeterUniversity of SussexSouth London and Maudsley NHS Foundation TrustCollege of Medicine and Health, University of ExeterDepartment of Psychology, University of ExeterSouth London and Maudsley NHS Foundation TrustSouth London and Maudsley NHS Foundation TrustCollege of Medicine and Health, University of ExeterKing’s Health Economics, King’s College LondonCollege of Medicine and Health, University of ExeterCentre for Affective Disorders, King’s College LondonCollege of Medicine and Health, University of ExeterAbstract Background Major depression represents a pressing challenge for health care. In England, Increasing Access to Psychological Therapies (IAPT) services provide evidence-based psychological therapies in a stepped-care approach to patients with depression. While introduction of these services has successfully increased access to therapy, estimates suggest that about 50% of depressed patients who have come to the end of the IAPT pathway still show significant levels of symptoms. This study will investigate whether Mindfulness-Based Cognitive Therapy (MBCT), a group intervention combining training in mindfulness meditation and elements from cognitive therapy, can have beneficial effects in depressed patients who have not responded to high-intensity therapy in IAPT. It will seek to establish the effectiveness and cost-effectiveness of MBCT as compared to the treatment these patients would usually receive. Methods In a 2-arm randomised controlled trial, patients who currently meet the criteria for major depressive disorder and who have not sufficiently responded to at least 12 sessions of IAPT high-intensity therapy will be allocated, at a ratio of 1:1, to receive either MBCT (in addition to treatment as usual [TAU]) or continue with TAU only. Assessments will take place at baseline, 10 weeks and 34 weeks post-randomisation. The primary outcome will be reduction in depression symptomatology 34 weeks post-randomisation as assessed using the Public Health Questionnaire-9 (PHQ-9). Secondary outcomes will include depressive symptomatology at 10 weeks post-randomisation and other clinical outcomes measured at 10-week and 34-week follow-up, along with a series of binarised outcomes to indicate clinically significant and reliable change. Evaluations of cost-effectiveness will be based on assessments of service use costs collected using the Adult Service Use Schedule and health utilities derived from the EQ-5D. Discussion This trial will add to the evidence base for the use of MBCT in depressed treatment non-responders. It will constitute the first trial to test MBCT following non-response to psychological therapy, with results providing a direct estimate of efficacy within the IAPT pathway. As such, its results will offer an important basis for decisions regarding the adoption of MBCT for non-responders within IAPT. Trial registration ClinicalTrials.gov NCT05236959. Registered on 11 February 2022. ISRCTN 17755571. Registered on 2 February 2021.https://doi.org/10.1186/s13063-022-06882-wMindfulness-Based Cognitive TherapyMajor depressive disorderTreatment non-responseIncreasing Access for Psychological Therapies (IAPT) |
| spellingShingle | Thorsten Barnhofer Barnaby D. Dunn Clara Strauss Florian Ruths Barbara Barrett Mary Ryan Asha Ladwa Frances Stafford Roberta Fichera Hannah Baber Ailis McGuinness Isabella Metcalfe Delilah Harding Sarah Walker Poushali Ganguli Shelley Rhodes Allan Young Fiona Warren A randomised controlled trial to investigate the clinical effectiveness and cost effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for depressed non-responders to Increasing Access to Psychological Therapies (IAPT) high-intensity therapies: study protocol Trials Mindfulness-Based Cognitive Therapy Major depressive disorder Treatment non-response Increasing Access for Psychological Therapies (IAPT) |
| title | A randomised controlled trial to investigate the clinical effectiveness and cost effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for depressed non-responders to Increasing Access to Psychological Therapies (IAPT) high-intensity therapies: study protocol |
| title_full | A randomised controlled trial to investigate the clinical effectiveness and cost effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for depressed non-responders to Increasing Access to Psychological Therapies (IAPT) high-intensity therapies: study protocol |
| title_fullStr | A randomised controlled trial to investigate the clinical effectiveness and cost effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for depressed non-responders to Increasing Access to Psychological Therapies (IAPT) high-intensity therapies: study protocol |
| title_full_unstemmed | A randomised controlled trial to investigate the clinical effectiveness and cost effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for depressed non-responders to Increasing Access to Psychological Therapies (IAPT) high-intensity therapies: study protocol |
| title_short | A randomised controlled trial to investigate the clinical effectiveness and cost effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for depressed non-responders to Increasing Access to Psychological Therapies (IAPT) high-intensity therapies: study protocol |
| title_sort | randomised controlled trial to investigate the clinical effectiveness and cost effectiveness of mindfulness based cognitive therapy mbct for depressed non responders to increasing access to psychological therapies iapt high intensity therapies study protocol |
| topic | Mindfulness-Based Cognitive Therapy Major depressive disorder Treatment non-response Increasing Access for Psychological Therapies (IAPT) |
| url | https://doi.org/10.1186/s13063-022-06882-w |
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