Effectiveness of a cognitive behavioural intervention for patients with undifferentiated somatoform disorder: Results from the CIPRUS cluster randomized controlled trial in primary care

Kate Sitnikova; Stephanie S Leone; Harm W J van Marwijk; Jos Twisk; Henriëtte E van der Horst; Johannes C van der Wouden

doi:10.1016/j.jpsychores.2019.109745

Effectiveness of a cognitive behavioural intervention for patients with undifferentiated somatoform disorder: Results from the CIPRUS cluster randomized controlled trial in primary care

Kate Sitnikova
, Stephanie S Leone
, Harm W J van Marwijk
, Jos Twisk
, Henriëtte E van der Horst
, Johannes C van der Wouden

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

OBJECTIVE: To examine the effectiveness of a cognitive behavioural intervention delivered by mental health nurse practitioners (MHNPs) to patients with undifferentiated somatoform disorder (USD), compared to usual care.

METHODS: We conducted a cluster randomized trial among primary care patients with USD comparing the intervention to usual care. The intervention consisted of six sessions with the MHNP. Primary outcome was physical functioning (RAND-36 physical component summary score). Secondary outcomes were the RAND-36 mental component summary score and the eight subscales; anxiety and depression (Hospital Anxiety and Depression Scale) and somatic symptom severity (Patient Health Questionnaire-15). Outcomes were assessed at baseline, 2, 4 and 12 months. We analysed data using linear mixed models by intention-to-treat, and investigated effect modifiers.

RESULTS: Compared to usual care (n = 87), the intervention group (n = 111) showed an improvement in physical functioning (mean difference 2.24 [95% CI 0.51; 3.97]; p = .011), a decrease in limitations due to physical problems (mean difference 10.82 [95% CI 2.14; 19.49]; p. = 0.015) and in pain (mean difference 5.08 [95% CI 0.58; 9.57]; p = .027), over 12 months. However effect sizes were small and less clinically relevant than expected. We found no differences for anxiety, depression and somatic symptom severity. Effects were larger and clinically relevant for patients with more recent symptoms and fewer physical diseases.

CONCLUSION: The cognitive behavioural intervention was effective in improving pain and physical functioning components of patients' health. It was particularly suitable for patients with symptoms that had been present for a limited number of years and with few comorbid physical diseases.

TRIAL REGISTRATION: The trial is registered in the Dutch Trial Registry, www.trialregister.nl, under NTR4686.

Original language	English
Article number	109745
Journal	Journal of psychosomatic research
Volume	127
Early online date	24 Jun 2019
DOIs	https://doi.org/10.1016/j.jpsychores.2019.109745
Publication status	Published - Dec 2019

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Cognitive behavioural therapy (CBT)
General practice
Medically unexplained physical symptoms
Primary care
Problem-solving treatment
Undifferentiated somatoform disorder

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10.1016/j.jpsychores.2019.109745

Cite this

Sitnikova, K., Leone, S. S., van Marwijk, H. W. J., Twisk, J., van der Horst, H. E., & van der Wouden, J. C. (2019). Effectiveness of a cognitive behavioural intervention for patients with undifferentiated somatoform disorder: Results from the CIPRUS cluster randomized controlled trial in primary care. Journal of psychosomatic research, 127, Article 109745. https://doi.org/10.1016/j.jpsychores.2019.109745

@article{52e536f382c146328c5815a513ef0f6a,

title = "Effectiveness of a cognitive behavioural intervention for patients with undifferentiated somatoform disorder: Results from the CIPRUS cluster randomized controlled trial in primary care",

abstract = "OBJECTIVE: To examine the effectiveness of a cognitive behavioural intervention delivered by mental health nurse practitioners (MHNPs) to patients with undifferentiated somatoform disorder (USD), compared to usual care.METHODS: We conducted a cluster randomized trial among primary care patients with USD comparing the intervention to usual care. The intervention consisted of six sessions with the MHNP. Primary outcome was physical functioning (RAND-36 physical component summary score). Secondary outcomes were the RAND-36 mental component summary score and the eight subscales; anxiety and depression (Hospital Anxiety and Depression Scale) and somatic symptom severity (Patient Health Questionnaire-15). Outcomes were assessed at baseline, 2, 4 and 12 months. We analysed data using linear mixed models by intention-to-treat, and investigated effect modifiers.RESULTS: Compared to usual care (n = 87), the intervention group (n = 111) showed an improvement in physical functioning (mean difference 2.24 [95\% CI 0.51; 3.97]; p = .011), a decrease in limitations due to physical problems (mean difference 10.82 [95\% CI 2.14; 19.49]; p. = 0.015) and in pain (mean difference 5.08 [95\% CI 0.58; 9.57]; p = .027), over 12 months. However effect sizes were small and less clinically relevant than expected. We found no differences for anxiety, depression and somatic symptom severity. Effects were larger and clinically relevant for patients with more recent symptoms and fewer physical diseases.CONCLUSION: The cognitive behavioural intervention was effective in improving pain and physical functioning components of patients' health. It was particularly suitable for patients with symptoms that had been present for a limited number of years and with few comorbid physical diseases.TRIAL REGISTRATION: The trial is registered in the Dutch Trial Registry, www.trialregister.nl, under NTR4686.",

keywords = "Cognitive behavioural therapy (CBT), General practice, Medically unexplained physical symptoms, Primary care, Problem-solving treatment, Undifferentiated somatoform disorder",

author = "Kate Sitnikova and Leone, \{Stephanie S\} and \{van Marwijk\}, \{Harm W J\} and Jos Twisk and \{van der Horst\}, \{Henri{\"e}tte E\} and \{van der Wouden\}, \{Johannes C\}",

year = "2019",

month = dec,

doi = "10.1016/j.jpsychores.2019.109745",

language = "English",

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journal = "Journal of psychosomatic research",

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Sitnikova, K, Leone, SS, van Marwijk, HWJ, Twisk, J , van der Horst, HE & van der Wouden, JC 2019, 'Effectiveness of a cognitive behavioural intervention for patients with undifferentiated somatoform disorder: Results from the CIPRUS cluster randomized controlled trial in primary care', Journal of psychosomatic research, vol. 127, 109745. https://doi.org/10.1016/j.jpsychores.2019.109745

Effectiveness of a cognitive behavioural intervention for patients with undifferentiated somatoform disorder: Results from the CIPRUS cluster randomized controlled trial in primary care. / Sitnikova, Kate; Leone, Stephanie S; van Marwijk, Harm W J et al.
In: Journal of psychosomatic research, Vol. 127, 109745, 12.2019.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Effectiveness of a cognitive behavioural intervention for patients with undifferentiated somatoform disorder

T2 - Results from the CIPRUS cluster randomized controlled trial in primary care

AU - Sitnikova, Kate

AU - Leone, Stephanie S

AU - van Marwijk, Harm W J

AU - Twisk, Jos

AU - van der Horst, Henriëtte E

AU - van der Wouden, Johannes C

PY - 2019/12

Y1 - 2019/12

N2 - OBJECTIVE: To examine the effectiveness of a cognitive behavioural intervention delivered by mental health nurse practitioners (MHNPs) to patients with undifferentiated somatoform disorder (USD), compared to usual care.METHODS: We conducted a cluster randomized trial among primary care patients with USD comparing the intervention to usual care. The intervention consisted of six sessions with the MHNP. Primary outcome was physical functioning (RAND-36 physical component summary score). Secondary outcomes were the RAND-36 mental component summary score and the eight subscales; anxiety and depression (Hospital Anxiety and Depression Scale) and somatic symptom severity (Patient Health Questionnaire-15). Outcomes were assessed at baseline, 2, 4 and 12 months. We analysed data using linear mixed models by intention-to-treat, and investigated effect modifiers.RESULTS: Compared to usual care (n = 87), the intervention group (n = 111) showed an improvement in physical functioning (mean difference 2.24 [95% CI 0.51; 3.97]; p = .011), a decrease in limitations due to physical problems (mean difference 10.82 [95% CI 2.14; 19.49]; p. = 0.015) and in pain (mean difference 5.08 [95% CI 0.58; 9.57]; p = .027), over 12 months. However effect sizes were small and less clinically relevant than expected. We found no differences for anxiety, depression and somatic symptom severity. Effects were larger and clinically relevant for patients with more recent symptoms and fewer physical diseases.CONCLUSION: The cognitive behavioural intervention was effective in improving pain and physical functioning components of patients' health. It was particularly suitable for patients with symptoms that had been present for a limited number of years and with few comorbid physical diseases.TRIAL REGISTRATION: The trial is registered in the Dutch Trial Registry, www.trialregister.nl, under NTR4686.

AB - OBJECTIVE: To examine the effectiveness of a cognitive behavioural intervention delivered by mental health nurse practitioners (MHNPs) to patients with undifferentiated somatoform disorder (USD), compared to usual care.METHODS: We conducted a cluster randomized trial among primary care patients with USD comparing the intervention to usual care. The intervention consisted of six sessions with the MHNP. Primary outcome was physical functioning (RAND-36 physical component summary score). Secondary outcomes were the RAND-36 mental component summary score and the eight subscales; anxiety and depression (Hospital Anxiety and Depression Scale) and somatic symptom severity (Patient Health Questionnaire-15). Outcomes were assessed at baseline, 2, 4 and 12 months. We analysed data using linear mixed models by intention-to-treat, and investigated effect modifiers.RESULTS: Compared to usual care (n = 87), the intervention group (n = 111) showed an improvement in physical functioning (mean difference 2.24 [95% CI 0.51; 3.97]; p = .011), a decrease in limitations due to physical problems (mean difference 10.82 [95% CI 2.14; 19.49]; p. = 0.015) and in pain (mean difference 5.08 [95% CI 0.58; 9.57]; p = .027), over 12 months. However effect sizes were small and less clinically relevant than expected. We found no differences for anxiety, depression and somatic symptom severity. Effects were larger and clinically relevant for patients with more recent symptoms and fewer physical diseases.CONCLUSION: The cognitive behavioural intervention was effective in improving pain and physical functioning components of patients' health. It was particularly suitable for patients with symptoms that had been present for a limited number of years and with few comorbid physical diseases.TRIAL REGISTRATION: The trial is registered in the Dutch Trial Registry, www.trialregister.nl, under NTR4686.

KW - Cognitive behavioural therapy (CBT)

KW - General practice

KW - Medically unexplained physical symptoms

KW - Primary care

KW - Problem-solving treatment

KW - Undifferentiated somatoform disorder

UR - https://www.scopus.com/pages/publications/85068398723

U2 - 10.1016/j.jpsychores.2019.109745

DO - 10.1016/j.jpsychores.2019.109745

M3 - Article

SN - 0022-3999

VL - 127

JO - Journal of psychosomatic research

JF - Journal of psychosomatic research

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Sitnikova K, Leone SS, van Marwijk HWJ, Twisk J , van der Horst HE , van der Wouden JC. Effectiveness of a cognitive behavioural intervention for patients with undifferentiated somatoform disorder: Results from the CIPRUS cluster randomized controlled trial in primary care. Journal of psychosomatic research. 2019 Dec;127:109745. Epub 2019 Jun 24. doi: 10.1016/j.jpsychores.2019.109745

Effectiveness of a cognitive behavioural intervention for patients with undifferentiated somatoform disorder: Results from the CIPRUS cluster randomized controlled trial in primary care

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Keywords

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