The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care: study protocol for a randomised controlled trial
Abstract Background Up to a third of patients presenting medically unexplained physical symptoms in primary care may have a somatoform disorder, of which undifferentiated somatoform disorder (USD) is the most common type. Psychological interventions can reduce symptoms associated with USD and improv...
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| Format: | Article |
| Language: | English |
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BMC
2017-05-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-1951-2 |
| _version_ | 1828452495982067712 |
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| author | Kate Sitnikova Stephanie S. Leone Lyonne N. L. Zonneveld Harm W. J. van Marwijk Judith E. Bosmans Johannes C. van der Wouden Henriëtte E. van der Horst |
| author_facet | Kate Sitnikova Stephanie S. Leone Lyonne N. L. Zonneveld Harm W. J. van Marwijk Judith E. Bosmans Johannes C. van der Wouden Henriëtte E. van der Horst |
| author_sort | Kate Sitnikova |
| collection | DOAJ |
| description | Abstract Background Up to a third of patients presenting medically unexplained physical symptoms in primary care may have a somatoform disorder, of which undifferentiated somatoform disorder (USD) is the most common type. Psychological interventions can reduce symptoms associated with USD and improve functioning. Previous research has either been conducted in secondary care or interventions have been provided by general practitioners (GPs) or psychologists in primary care. As efficiency and cost-effectiveness are imperative in primary care, it is important to investigate whether nurse-led interventions are effective as well. The aim of this study is to examine the effectiveness and cost-effectiveness of a short cognitive behavioural therapy (CBT)-based treatment for patients with USD provided by mental health nurse practitioners (MHNPs), compared to usual care. Methods In a cluster randomised controlled trial, 212 adult patients with USD will be assigned to the intervention or care as usual. The intervention group will be offered a short, individual CBT-based treatment by the MHNP in addition to usual GP care. The main goal of the intervention is that patients become less impaired by their physical symptoms and cope with symptoms in a more effective way. In six sessions patients will receive problem-solving treatment. The primary outcome is improvement in physical functioning, measured by the physical component summary score of the RAND-36. Secondary outcomes include health-related quality of life measured by the separate subscales of the RAND-36, somatization (PHQ-15) and symptoms of depression and anxiety (HADS). Problem-solving skills, health anxiety, illness perceptions, coping, mastery and working alliance will be assessed as potential mediators. Assessments will be done at 0, 2, 4, 8 and 12 months. An economic evaluation will be conducted from a societal perspective with quality of life as the primary outcome measure assessed by the EQ-5D-5L. Health care, patient and lost productivity costs will be assessed with the Tic-P. Discussion We expect that the intervention will improve physical functioning and is cost-effective compared to usual care. If so, more patients might successfully be treated in general practice, decreasing the number of referrals to specialist care. Trial registration Dutch Trial Registry, identifier: NTR4686 , Registered on 14 July 2014. |
| first_indexed | 2024-12-10T23:52:49Z |
| format | Article |
| id | doaj.art-19f8a2b30d514a37ba54198b7fb7dfdc |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-10T23:52:49Z |
| publishDate | 2017-05-01 |
| publisher | BMC |
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| series | Trials |
| spelling | doaj.art-19f8a2b30d514a37ba54198b7fb7dfdc2022-12-22T01:28:40ZengBMCTrials1745-62152017-05-0118111310.1186/s13063-017-1951-2The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care: study protocol for a randomised controlled trialKate Sitnikova0Stephanie S. Leone1Lyonne N. L. Zonneveld2Harm W. J. van Marwijk3Judith E. Bosmans4Johannes C. van der Wouden5Henriëtte E. van der Horst6Department of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, VU University Medical CenterDepartment of Public Mental Health, Trimbos Institute: Netherlands Institute of Mental Health and AddictionDepartment of Anaesthesiology, Academic Medical Center, University of AmsterdamCentre for Primary Care, Institute of Population Health, University of ManchesterDepartment of Health Sciences, Amsterdam Public Health Research Institute, Faculty of Earth and Life Sciences, Vrije Universiteit AmsterdamDepartment of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, VU University Medical CenterDepartment of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, VU University Medical CenterAbstract Background Up to a third of patients presenting medically unexplained physical symptoms in primary care may have a somatoform disorder, of which undifferentiated somatoform disorder (USD) is the most common type. Psychological interventions can reduce symptoms associated with USD and improve functioning. Previous research has either been conducted in secondary care or interventions have been provided by general practitioners (GPs) or psychologists in primary care. As efficiency and cost-effectiveness are imperative in primary care, it is important to investigate whether nurse-led interventions are effective as well. The aim of this study is to examine the effectiveness and cost-effectiveness of a short cognitive behavioural therapy (CBT)-based treatment for patients with USD provided by mental health nurse practitioners (MHNPs), compared to usual care. Methods In a cluster randomised controlled trial, 212 adult patients with USD will be assigned to the intervention or care as usual. The intervention group will be offered a short, individual CBT-based treatment by the MHNP in addition to usual GP care. The main goal of the intervention is that patients become less impaired by their physical symptoms and cope with symptoms in a more effective way. In six sessions patients will receive problem-solving treatment. The primary outcome is improvement in physical functioning, measured by the physical component summary score of the RAND-36. Secondary outcomes include health-related quality of life measured by the separate subscales of the RAND-36, somatization (PHQ-15) and symptoms of depression and anxiety (HADS). Problem-solving skills, health anxiety, illness perceptions, coping, mastery and working alliance will be assessed as potential mediators. Assessments will be done at 0, 2, 4, 8 and 12 months. An economic evaluation will be conducted from a societal perspective with quality of life as the primary outcome measure assessed by the EQ-5D-5L. Health care, patient and lost productivity costs will be assessed with the Tic-P. Discussion We expect that the intervention will improve physical functioning and is cost-effective compared to usual care. If so, more patients might successfully be treated in general practice, decreasing the number of referrals to specialist care. Trial registration Dutch Trial Registry, identifier: NTR4686 , Registered on 14 July 2014.http://link.springer.com/article/10.1186/s13063-017-1951-2General practicePrimary careProblem-solving treatment (PST)Undifferentiated somatoform disorderMedically unexplained physical symptomsCost-effectiveness |
| spellingShingle | Kate Sitnikova Stephanie S. Leone Lyonne N. L. Zonneveld Harm W. J. van Marwijk Judith E. Bosmans Johannes C. van der Wouden Henriëtte E. van der Horst The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care: study protocol for a randomised controlled trial Trials General practice Primary care Problem-solving treatment (PST) Undifferentiated somatoform disorder Medically unexplained physical symptoms Cost-effectiveness |
| title | The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care: study protocol for a randomised controlled trial |
| title_full | The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care: study protocol for a randomised controlled trial |
| title_fullStr | The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care: study protocol for a randomised controlled trial |
| title_full_unstemmed | The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care: study protocol for a randomised controlled trial |
| title_short | The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care: study protocol for a randomised controlled trial |
| title_sort | ciprus study a nurse led psychological treatment for patients with undifferentiated somatoform disorder in primary care study protocol for a randomised controlled trial |
| topic | General practice Primary care Problem-solving treatment (PST) Undifferentiated somatoform disorder Medically unexplained physical symptoms Cost-effectiveness |
| url | http://link.springer.com/article/10.1186/s13063-017-1951-2 |
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