Randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of selective serotonin reuptake inhibitors plus supportive care, versus supportive care alone, for mild to moderate depression with somatic symptoms in primary care: the THREAD (THREshold for AntiDepressant response) study
Objectives: To determine (1) the effectiveness and cost-effectiveness of selective serotonin reuptake inhibitor (SSRI) treatment plus supportive care, versus supportive care alone, for mild to moderate depression in patients with somatic symptoms in primary care; and (2) the impact of the initial se...
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| Format: | Article |
| Language: | English |
| Published: |
NIHR Journals Library
2009-04-01
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| Series: | Health Technology Assessment |
| Subjects: | |
| Online Access: | https://doi.org/10.3310/hta13220 |
| _version_ | 1828350725302779904 |
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| author | T Kendrick J Chatwin C Dowrick A Tylee R Morriss R Peveler M Leese P McCrone T Harris M Moore R Byng G Brown S Barthel H Mander A Ring V Kelly V Wallace M Gabbay T Craig A Mann |
| author_facet | T Kendrick J Chatwin C Dowrick A Tylee R Morriss R Peveler M Leese P McCrone T Harris M Moore R Byng G Brown S Barthel H Mander A Ring V Kelly V Wallace M Gabbay T Craig A Mann |
| author_sort | T Kendrick |
| collection | DOAJ |
| description | Objectives: To determine (1) the effectiveness and cost-effectiveness of selective serotonin reuptake inhibitor (SSRI) treatment plus supportive care, versus supportive care alone, for mild to moderate depression in patients with somatic symptoms in primary care; and (2) the impact of the initial severity of depression on effectiveness and relative costs. To investigate the impact of demographic and social variables. Design: The study was a parallel group, open-label, pragmatic randomised controlled trial. Setting: The study took place in a UK primary care setting. Patients were referred by 177 GPs from 115 practices around three academic centres. Participants: Patients diagnosed with new episodes of depression and potentially in need of treatment. In total, 602 patients were referred to the study team, of whom 220 were randomised. Interventions: GPs were asked to provide supportive care to all participants in follow-up consultations 2, 4, 8 and 12 weeks after the baseline assessment, to prescribe an SSRI of their choice to patients in the SSRI plus supportive care arm and to continue treatment for at least 4 months after recovery. They could switch antidepressants during treatment if necessary. They were asked to refrain from prescribing an antidepressant to those in the supportive care alone arm during the first 12 weeks but could prescribe to these patients if treatment became necessary. Main outcome measures: The primary outcome measure was Hamilton Depression Rating Scale (HDRS) score at 12-week follow-up. Secondary outcome measures were scores on HDRS at 26-week follow-up, Beck Depression Inventory, Medical Outcomes Study Short Form-36 (SF-36), Medical Interview Satisfaction Scale (MISS), modified Client Service Receipt Inventory and medical record data. Results: SSRIs were received by 87% of patients in the SSRI plus supportive care arm and 20% in the supportive care alone arm. Longitudinal analyses demonstrated statistically significant differences in favour of the SSRI plus supportive care arm in terms of lower HDRS scores and higher scores on the SF-36 and MISS. Significant mean differences in HDRS score adjusted for baseline were found at both follow-up points when analysed separately but were relatively small. The numbers needed to treat for remission (to HDRS < 8) were 6 [95% confidence interval (CI) 4 to 26)] at 12 weeks and 6 (95% CI 3 to 31) at 26 weeks, and for significant improvement (HDRS reduction ≥ 50%) were 7 (95% CI 4 to 83) and 5 (95% CI 3 to 13) respectively. Incremental cost-effectiveness ratios and cost-effectiveness planes suggested that adding an SSRI to supportive care was probably cost-effective. The cost-effectiveness acceptability curve for utility suggested that adding an SSRI to supportive care was cost-effective at the values of £20,000–£30,000 per quality-adjusted life-year. A poorer outcome on the HDRS was significantly related to greater severity at baseline, a higher physical symptom score and being unemployed. Conclusions: Treatment with an SSRI plus supportive care is more effective than supportive care alone for patients with mild to moderate depression, at least for those with symptoms persisting for 8 weeks and an HRDS score of ≥ 12. The additional benefit is relatively small, and may be at least in part a placebo effect, but is probably cost-effective at the level used by the National Institute for Health and Clinical Excellence to make judgements about recommending treatments within the National Health Service. However, further research is required. Trial registration: Current Controlled Trials ISRCTN84854789. |
| first_indexed | 2024-04-14T01:30:12Z |
| format | Article |
| id | doaj.art-a5d5c5e526344572b6d598960fdf357b |
| institution | Directory Open Access Journal |
| issn | 1366-5278 2046-4924 |
| language | English |
| last_indexed | 2024-04-14T01:30:12Z |
| publishDate | 2009-04-01 |
| publisher | NIHR Journals Library |
| record_format | Article |
| series | Health Technology Assessment |
| spelling | doaj.art-a5d5c5e526344572b6d598960fdf357b2022-12-22T02:20:14ZengNIHR Journals LibraryHealth Technology Assessment1366-52782046-49242009-04-01132210.3310/hta1322001/70/05Randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of selective serotonin reuptake inhibitors plus supportive care, versus supportive care alone, for mild to moderate depression with somatic symptoms in primary care: the THREAD (THREshold for AntiDepressant response) studyT Kendrick0J Chatwin1C Dowrick2A Tylee3R Morriss4R Peveler5M Leese6P McCrone7T Harris8M Moore9R Byng10G Brown11S Barthel12H Mander13A Ring14V Kelly15V Wallace16M Gabbay17T Craig18A Mann19Primary Medical Care, Aldermoor Health Centre, University of Southampton, UKPrimary Medical Care, Aldermoor Health Centre, University of Southampton, UKUniversity of Liverpool, UKInstitute of Psychiatry, King’s College London, UKUniversity of Nottingham, UKPrimary Medical Care, Aldermoor Health Centre, University of Southampton, UKInstitute of Psychiatry, King’s College London, UKInstitute of Psychiatry, King’s College London, UKKing’s College, London, UKPrimary Medical Care, Aldermoor Health Centre, University of Southampton, UKPeninsula Medical School, Plymouth, UKKing’s College, London, UKInstitute of Psychiatry, King’s College London, UKPrimary Medical Care, Aldermoor Health Centre, University of Southampton, UKUniversity of Liverpool, UKInstitute of Psychiatry, King’s College London, UKInstitute of Psychiatry, King’s College London, UKUniversity of Liverpool, UKKing’s College, London, UKInstitute of Psychiatry, King’s College London, UKObjectives: To determine (1) the effectiveness and cost-effectiveness of selective serotonin reuptake inhibitor (SSRI) treatment plus supportive care, versus supportive care alone, for mild to moderate depression in patients with somatic symptoms in primary care; and (2) the impact of the initial severity of depression on effectiveness and relative costs. To investigate the impact of demographic and social variables. Design: The study was a parallel group, open-label, pragmatic randomised controlled trial. Setting: The study took place in a UK primary care setting. Patients were referred by 177 GPs from 115 practices around three academic centres. Participants: Patients diagnosed with new episodes of depression and potentially in need of treatment. In total, 602 patients were referred to the study team, of whom 220 were randomised. Interventions: GPs were asked to provide supportive care to all participants in follow-up consultations 2, 4, 8 and 12 weeks after the baseline assessment, to prescribe an SSRI of their choice to patients in the SSRI plus supportive care arm and to continue treatment for at least 4 months after recovery. They could switch antidepressants during treatment if necessary. They were asked to refrain from prescribing an antidepressant to those in the supportive care alone arm during the first 12 weeks but could prescribe to these patients if treatment became necessary. Main outcome measures: The primary outcome measure was Hamilton Depression Rating Scale (HDRS) score at 12-week follow-up. Secondary outcome measures were scores on HDRS at 26-week follow-up, Beck Depression Inventory, Medical Outcomes Study Short Form-36 (SF-36), Medical Interview Satisfaction Scale (MISS), modified Client Service Receipt Inventory and medical record data. Results: SSRIs were received by 87% of patients in the SSRI plus supportive care arm and 20% in the supportive care alone arm. Longitudinal analyses demonstrated statistically significant differences in favour of the SSRI plus supportive care arm in terms of lower HDRS scores and higher scores on the SF-36 and MISS. Significant mean differences in HDRS score adjusted for baseline were found at both follow-up points when analysed separately but were relatively small. The numbers needed to treat for remission (to HDRS < 8) were 6 [95% confidence interval (CI) 4 to 26)] at 12 weeks and 6 (95% CI 3 to 31) at 26 weeks, and for significant improvement (HDRS reduction ≥ 50%) were 7 (95% CI 4 to 83) and 5 (95% CI 3 to 13) respectively. Incremental cost-effectiveness ratios and cost-effectiveness planes suggested that adding an SSRI to supportive care was probably cost-effective. The cost-effectiveness acceptability curve for utility suggested that adding an SSRI to supportive care was cost-effective at the values of £20,000–£30,000 per quality-adjusted life-year. A poorer outcome on the HDRS was significantly related to greater severity at baseline, a higher physical symptom score and being unemployed. Conclusions: Treatment with an SSRI plus supportive care is more effective than supportive care alone for patients with mild to moderate depression, at least for those with symptoms persisting for 8 weeks and an HRDS score of ≥ 12. The additional benefit is relatively small, and may be at least in part a placebo effect, but is probably cost-effective at the level used by the National Institute for Health and Clinical Excellence to make judgements about recommending treatments within the National Health Service. However, further research is required. Trial registration: Current Controlled Trials ISRCTN84854789.https://doi.org/10.3310/hta13220primary-carecost-effectivenesshamilton-depression-rating-scalemild depressionmoderate-depressionselective-serotonin-reuptake-inhibitor |
| spellingShingle | T Kendrick J Chatwin C Dowrick A Tylee R Morriss R Peveler M Leese P McCrone T Harris M Moore R Byng G Brown S Barthel H Mander A Ring V Kelly V Wallace M Gabbay T Craig A Mann Randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of selective serotonin reuptake inhibitors plus supportive care, versus supportive care alone, for mild to moderate depression with somatic symptoms in primary care: the THREAD (THREshold for AntiDepressant response) study Health Technology Assessment primary-care cost-effectiveness hamilton-depression-rating-scale mild depression moderate-depression selective-serotonin-reuptake-inhibitor |
| title | Randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of selective serotonin reuptake inhibitors plus supportive care, versus supportive care alone, for mild to moderate depression with somatic symptoms in primary care: the THREAD (THREshold for AntiDepressant response) study |
| title_full | Randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of selective serotonin reuptake inhibitors plus supportive care, versus supportive care alone, for mild to moderate depression with somatic symptoms in primary care: the THREAD (THREshold for AntiDepressant response) study |
| title_fullStr | Randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of selective serotonin reuptake inhibitors plus supportive care, versus supportive care alone, for mild to moderate depression with somatic symptoms in primary care: the THREAD (THREshold for AntiDepressant response) study |
| title_full_unstemmed | Randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of selective serotonin reuptake inhibitors plus supportive care, versus supportive care alone, for mild to moderate depression with somatic symptoms in primary care: the THREAD (THREshold for AntiDepressant response) study |
| title_short | Randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of selective serotonin reuptake inhibitors plus supportive care, versus supportive care alone, for mild to moderate depression with somatic symptoms in primary care: the THREAD (THREshold for AntiDepressant response) study |
| title_sort | randomised controlled trial to determine the clinical effectiveness and cost effectiveness of selective serotonin reuptake inhibitors plus supportive care versus supportive care alone for mild to moderate depression with somatic symptoms in primary care the thread threshold for antidepressant response study |
| topic | primary-care cost-effectiveness hamilton-depression-rating-scale mild depression moderate-depression selective-serotonin-reuptake-inhibitor |
| url | https://doi.org/10.3310/hta13220 |
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