Economic evaluation of an e-mental health intervention for patients with retinal exudative diseases who receive intra-ocular anti-VEGF injections (E-PsEYE): protocol for a randomised controlled trial.

HPA van der Aa; G.H.M.B. van Rens; F.D. Verbraak; M Bosscha; M.A. Koopmanschap; H.C. Comijs; P. Cuijpers; R.M.A. van Nispen

doi:10.1136/bmjopen-2017-018149

Economic evaluation of an e-mental health intervention for patients with retinal exudative diseases who receive intra-ocular anti-VEGF injections (E-PsEYE): protocol for a randomised controlled trial.

HPA van der Aa
, G.H.M.B. van Rens
, F.D. Verbraak
, M Bosscha
, M.A. Koopmanschap
, H.C. Comijs
, P. Cuijpers
, R.M.A. van Nispen

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

Abstract

Introduction Because of the great potential of vascular endothelial growth factor inhibitors (anti-VEGF) for retinal exudative diseases, an increased number of patients receives this treatment. However, during this treatment, patients are subjected to frequent invasive intravitreal injections, and the effects on reversing the process of vision loss are uncertain, which may have negative consequences for patients’ mental health. One in three patients experience at least mild symptoms of depression/anxiety. To support patients in dealing with these symptoms, an e-mental health intervention (called E-PsEYE) has been developed. E-PsEYE is based on cognitive–behavioural therapy (CBT) and contains nine modules. A stepped-care model with three steps will be used to deliver the intervention: (1) providing information and psychoeducation, (2) when symptoms of depression/anxiety persist, guided CBT is offered and supported by social workers from low vision rehabilitation services and (3) when symptoms still persist, patients are referred to their general practitioner.

Methods and analysis An economic evaluation from a healthcare and societal perspective will be conducted alongside a multicentre randomised controlled trial in two parallel groups to evaluate whether E-PsEYE is cost-effective in comparison with usual care. Participants (n=174) will be 50 years or older, have retinal exudative diseases, receive anti-VEGF treatment and have mild symptoms of depression/anxiety (assessed prior to randomisation). Main outcome measures are: depression (Patient Health Questionnaire-9), anxiety (Hospital Anxiety and Depression Scale-Anxiety) and quality-adjusted life-years (determined with the Health Utility Index-3 and the EuroQol-5 dimensions). Five measurements take place: at baseline and after 3, 6, 9 and 12 months.

Ethics and dissemination The study has been approved by the Medical Ethics Committee of the VU University Medical Centre Amsterdam. It will provide new and essential information on the cost-effectiveness of an innovative intervention for a vulnerable population. Outcomes will be disseminated through peer-reviewed publications and conference presentations.

Original language	English
Article number	e018149
Pages (from-to)	1-9
Number of pages	9
Journal	BMJ Open
Volume	7
Issue number	11
DOIs	https://doi.org/10.1136/bmjopen-2017-018149
Publication status	Published - 27 Mar 2017

Funding

Funding This study was supported by ZonMw Doelmatigheid, the Dutch Organisation for Health Research and Development (grant No 80-84300-98-71046). The sponsor had no role in the design and conduct of the study or in the writing of the manuscript. competing interests None declared. Ethics approval The study protocol was approved by the Medical Ethics Committee of the VU University Medical Centre Amsterdam, the Netherlands. Provenance and peer review Not commissioned; externally peer reviewed. open Access This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/ licenses/by-nc/4.0/ © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Funders	Funder number
Dutch Organisation for Health Research and Development	80-84300-98-71046
ZonMw

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van der Aa , HPA., van Rens, G. H. M. B., Verbraak, F. D., Bosscha, M., Koopmanschap, M. A., Comijs, H. C., Cuijpers, P., & van Nispen, R. M. A. (2017). Economic evaluation of an e-mental health intervention for patients with retinal exudative diseases who receive intra-ocular anti-VEGF injections (E-PsEYE): protocol for a randomised controlled trial. BMJ Open, 7(11), 1-9. Article e018149. https://doi.org/10.1136/bmjopen-2017-018149

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title = "Economic evaluation of an e-mental health intervention for patients with retinal exudative diseases who receive intra-ocular anti-VEGF injections (E-PsEYE): protocol for a randomised controlled trial.",

abstract = "Introduction Because of the great potential of vascular endothelial growth factor inhibitors (anti-VEGF) for retinal exudative diseases, an increased number of patients receives this treatment. However, during this treatment, patients are subjected to frequent invasive intravitreal injections, and the effects on reversing the process of vision loss are uncertain, which may have negative consequences for patients{\textquoteright} mental health. One in three patients experience at least mild symptoms of depression/anxiety. To support patients in dealing with these symptoms, an e-mental health intervention (called E-PsEYE) has been developed. E-PsEYE is based on cognitive–behavioural therapy (CBT) and contains nine modules. A stepped-care model with three steps will be used to deliver the intervention: (1) providing information and psychoeducation, (2) when symptoms of depression/anxiety persist, guided CBT is offered and supported by social workers from low vision rehabilitation services and (3) when symptoms still persist, patients are referred to their general practitioner. Methods and analysis An economic evaluation from a healthcare and societal perspective will be conducted alongside a multicentre randomised controlled trial in two parallel groups to evaluate whether E-PsEYE is cost-effective in comparison with usual care. Participants (n=174) will be 50 years or older, have retinal exudative diseases, receive anti-VEGF treatment and have mild symptoms of depression/anxiety (assessed prior to randomisation). Main outcome measures are: depression (Patient Health Questionnaire-9), anxiety (Hospital Anxiety and Depression Scale-Anxiety) and quality-adjusted life-years (determined with the Health Utility Index-3 and the EuroQol-5 dimensions). Five measurements take place: at baseline and after 3, 6, 9 and 12 months. Ethics and dissemination The study has been approved by the Medical Ethics Committee of the VU University Medical Centre Amsterdam. It will provide new and essential information on the cost-effectiveness of an innovative intervention for a vulnerable population. Outcomes will be disseminated through peer-reviewed publications and conference presentations.",

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van der Aa , HPA, van Rens, GHMB, Verbraak, FD, Bosscha, M, Koopmanschap, MA, Comijs, HC, Cuijpers, P & van Nispen, RMA 2017, 'Economic evaluation of an e-mental health intervention for patients with retinal exudative diseases who receive intra-ocular anti-VEGF injections (E-PsEYE): protocol for a randomised controlled trial.', BMJ Open, vol. 7, no. 11, e018149, pp. 1-9. https://doi.org/10.1136/bmjopen-2017-018149

Economic evaluation of an e-mental health intervention for patients with retinal exudative diseases who receive intra-ocular anti-VEGF injections (E-PsEYE): protocol for a randomised controlled trial. / van der Aa , HPA; van Rens, G.H.M.B.; Verbraak, F.D. et al.
In: BMJ Open, Vol. 7, No. 11, e018149, 27.03.2017, p. 1-9.

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

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AU - van der Aa , HPA

AU - van Rens, G.H.M.B.

AU - Verbraak, F.D.

AU - Bosscha, M

AU - Koopmanschap, M.A.

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N2 - Introduction Because of the great potential of vascular endothelial growth factor inhibitors (anti-VEGF) for retinal exudative diseases, an increased number of patients receives this treatment. However, during this treatment, patients are subjected to frequent invasive intravitreal injections, and the effects on reversing the process of vision loss are uncertain, which may have negative consequences for patients’ mental health. One in three patients experience at least mild symptoms of depression/anxiety. To support patients in dealing with these symptoms, an e-mental health intervention (called E-PsEYE) has been developed. E-PsEYE is based on cognitive–behavioural therapy (CBT) and contains nine modules. A stepped-care model with three steps will be used to deliver the intervention: (1) providing information and psychoeducation, (2) when symptoms of depression/anxiety persist, guided CBT is offered and supported by social workers from low vision rehabilitation services and (3) when symptoms still persist, patients are referred to their general practitioner. Methods and analysis An economic evaluation from a healthcare and societal perspective will be conducted alongside a multicentre randomised controlled trial in two parallel groups to evaluate whether E-PsEYE is cost-effective in comparison with usual care. Participants (n=174) will be 50 years or older, have retinal exudative diseases, receive anti-VEGF treatment and have mild symptoms of depression/anxiety (assessed prior to randomisation). Main outcome measures are: depression (Patient Health Questionnaire-9), anxiety (Hospital Anxiety and Depression Scale-Anxiety) and quality-adjusted life-years (determined with the Health Utility Index-3 and the EuroQol-5 dimensions). Five measurements take place: at baseline and after 3, 6, 9 and 12 months. Ethics and dissemination The study has been approved by the Medical Ethics Committee of the VU University Medical Centre Amsterdam. It will provide new and essential information on the cost-effectiveness of an innovative intervention for a vulnerable population. Outcomes will be disseminated through peer-reviewed publications and conference presentations.

AB - Introduction Because of the great potential of vascular endothelial growth factor inhibitors (anti-VEGF) for retinal exudative diseases, an increased number of patients receives this treatment. However, during this treatment, patients are subjected to frequent invasive intravitreal injections, and the effects on reversing the process of vision loss are uncertain, which may have negative consequences for patients’ mental health. One in three patients experience at least mild symptoms of depression/anxiety. To support patients in dealing with these symptoms, an e-mental health intervention (called E-PsEYE) has been developed. E-PsEYE is based on cognitive–behavioural therapy (CBT) and contains nine modules. A stepped-care model with three steps will be used to deliver the intervention: (1) providing information and psychoeducation, (2) when symptoms of depression/anxiety persist, guided CBT is offered and supported by social workers from low vision rehabilitation services and (3) when symptoms still persist, patients are referred to their general practitioner. Methods and analysis An economic evaluation from a healthcare and societal perspective will be conducted alongside a multicentre randomised controlled trial in two parallel groups to evaluate whether E-PsEYE is cost-effective in comparison with usual care. Participants (n=174) will be 50 years or older, have retinal exudative diseases, receive anti-VEGF treatment and have mild symptoms of depression/anxiety (assessed prior to randomisation). Main outcome measures are: depression (Patient Health Questionnaire-9), anxiety (Hospital Anxiety and Depression Scale-Anxiety) and quality-adjusted life-years (determined with the Health Utility Index-3 and the EuroQol-5 dimensions). Five measurements take place: at baseline and after 3, 6, 9 and 12 months. Ethics and dissemination The study has been approved by the Medical Ethics Committee of the VU University Medical Centre Amsterdam. It will provide new and essential information on the cost-effectiveness of an innovative intervention for a vulnerable population. Outcomes will be disseminated through peer-reviewed publications and conference presentations.

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Economic evaluation of an e-mental health intervention for patients with retinal exudative diseases who receive intra-ocular anti-VEGF injections (E-PsEYE): protocol for a randomised controlled trial.

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