Efficacy and cost-effectiveness of a blended cognitive behavioral therapy for depression in Spanish primary health care: Study protocol for a randomised non-inferiority trial

Ma Dolores Vara; Rocio Herrero; Ernestina Etchemendy; Macarena Espinoza; Rosa Ma Banos; Azucena Garcia-Palacios; Guillem Lera; Blanca Folch; Vicente Palop-Larrea; Pilar Vazquez; Manuel Franco-Martin; Annet Kleiboer; Heleen Riper; Cristina Botella

doi:10.1186/s12888-018-1638-6

Efficacy and cost-effectiveness of a blended cognitive behavioral therapy for depression in Spanish primary health care: Study protocol for a randomised non-inferiority trial

Ma Dolores Vara, Rocio Herrero, Ernestina Etchemendy, Macarena Espinoza, Rosa Ma Banos, Azucena Garcia-Palacios, Guillem Lera, Blanca Folch, Vicente Palop-Larrea, Pilar Vazquez, Manuel Franco-Martin, Annet Kleiboer, Heleen Riper, Cristina Botella

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

Abstract

Background: Data from primary health care in Spain show a high prevalence of the major depressive disorder. Blended treatment (combination of face-to-face and online components) seems to be a very promising tool for the optimization and dissemination of psychological treatments in a cost-effective form. Although there is growing data that confirm the advantages of blended therapies, few studies have analyzed their application in regular clinical practice. The objective of the present paper is to describe the protocol for a clinical study aimed at exploring the clinical and cost-effectiveness of a blended cognitive behavioral therapy (b-CBT) for depression, compared to treatment as usual (TAU) in a primary health care setting. Methods: A two-arm randomised controlled non-inferiority trial will be carried out, with repeated measures (baseline, 3 months, 6 months, and 12 months) under two conditions: b-CBT and TAU. The b-CBT program will consist in three face-to-face sessions and eight online sessions. The TAU is defined as the routine care delivered by the general practitioner for the treatment of depression in primary care. The primary outcome is a symptomatic change of depressive symptoms on the patient-health questionnaire (PHQ-9). Other secondary outcomes will be considered (e.g., quality of life, treatment preference). All participants must be 18 years of age or older and meet the diagnostic criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental disorders 4th edition. 156 participants will be recruited (78 per arm). Discussion: It is expected that b-CBT is clinically non-inferior when compared to TAU. This is the first study in Spain to use a b-CBT format in primary and specialized care, and this format could be an efficacious and cost-effective therapeutic strategy for the treatment of depression.

Original language	English
Article number	74
Pages (from-to)	1-9
Number of pages	9
Journal	BMC Psychiatry
Volume	18
DOIs	https://doi.org/10.1186/s12888-018-1638-6
Publication status	Published - 23 Mar 2018

Funding

This work was supported by the E-COMPARED project [European 7FP, Nº Agreement; 603098] under grants “PROMOSAM” [Ministerio de Economía y Competitividad; PSI2014-56303-REDT] and PROMETEOII/2013/003 program [Generalitat Valenciana]; CIBER of Physiopathology of Obesity Nutrition, an initiative of ISCIII (ISC III CB06 03/0052). This study is funded by the European Commission FP7-Health-2013-Innovation-1 program, grant agreement number: 603098.

Funders	Funder number
European Commission FP7-Health-2013-Innovation-1 program
VII Program Framework of the European Union
Center for International Business Education and Research, University of Illinois at Urbana-Champaign
Seventh Framework Programme	603098
Ministerio de Economía y Competitividad	PSI2014-56303-REDT, PROMETEOII/2013/003
Generalitat Valenciana
Instituto de Salud Carlos III	ISC III CB06 03/0052

Keywords

Blended treatment
Cognitive behavioral therapy
Depression
Internet-based treatment
Primary health care
Randomised non-inferiority trial

UN SDGs

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

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10.1186/s12888-018-1638-6

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Dolores Vara, M., Herrero, R., Etchemendy, E., Espinoza, M., Banos, R. M., Garcia-Palacios, A., Lera, G., Folch, B., Palop-Larrea, V., Vazquez, P., Franco-Martin, M., Kleiboer, A., Riper, H., & Botella, C. (2018). Efficacy and cost-effectiveness of a blended cognitive behavioral therapy for depression in Spanish primary health care: Study protocol for a randomised non-inferiority trial. BMC Psychiatry, 18, 1-9. Article 74. https://doi.org/10.1186/s12888-018-1638-6

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title = "Efficacy and cost-effectiveness of a blended cognitive behavioral therapy for depression in Spanish primary health care: Study protocol for a randomised non-inferiority trial",

abstract = "Background: Data from primary health care in Spain show a high prevalence of the major depressive disorder. Blended treatment (combination of face-to-face and online components) seems to be a very promising tool for the optimization and dissemination of psychological treatments in a cost-effective form. Although there is growing data that confirm the advantages of blended therapies, few studies have analyzed their application in regular clinical practice. The objective of the present paper is to describe the protocol for a clinical study aimed at exploring the clinical and cost-effectiveness of a blended cognitive behavioral therapy (b-CBT) for depression, compared to treatment as usual (TAU) in a primary health care setting. Methods: A two-arm randomised controlled non-inferiority trial will be carried out, with repeated measures (baseline, 3 months, 6 months, and 12 months) under two conditions: b-CBT and TAU. The b-CBT program will consist in three face-to-face sessions and eight online sessions. The TAU is defined as the routine care delivered by the general practitioner for the treatment of depression in primary care. The primary outcome is a symptomatic change of depressive symptoms on the patient-health questionnaire (PHQ-9). Other secondary outcomes will be considered (e.g., quality of life, treatment preference). All participants must be 18 years of age or older and meet the diagnostic criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental disorders 4th edition. 156 participants will be recruited (78 per arm). Discussion: It is expected that b-CBT is clinically non-inferior when compared to TAU. This is the first study in Spain to use a b-CBT format in primary and specialized care, and this format could be an efficacious and cost-effective therapeutic strategy for the treatment of depression.",

keywords = "Blended treatment, Cognitive behavioral therapy, Depression, Internet-based treatment, Primary health care, Randomised non-inferiority trial",

author = "{Dolores Vara}, Ma and Rocio Herrero and Ernestina Etchemendy and Macarena Espinoza and Banos, {Rosa Ma} and Azucena Garcia-Palacios and Guillem Lera and Blanca Folch and Vicente Palop-Larrea and Pilar Vazquez and Manuel Franco-Martin and Annet Kleiboer and Heleen Riper and Cristina Botella",

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Dolores Vara, M, Herrero, R, Etchemendy, E, Espinoza, M, Banos, RM, Garcia-Palacios, A, Lera, G, Folch, B, Palop-Larrea, V, Vazquez, P, Franco-Martin, M, Kleiboer, A , Riper, H & Botella, C 2018, 'Efficacy and cost-effectiveness of a blended cognitive behavioral therapy for depression in Spanish primary health care: Study protocol for a randomised non-inferiority trial', BMC Psychiatry, vol. 18, 74, pp. 1-9. https://doi.org/10.1186/s12888-018-1638-6

Efficacy and cost-effectiveness of a blended cognitive behavioral therapy for depression in Spanish primary health care: Study protocol for a randomised non-inferiority trial. / Dolores Vara, Ma; Herrero, Rocio; Etchemendy, Ernestina et al.
In: BMC Psychiatry, Vol. 18, 74, 23.03.2018, p. 1-9.

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

TY - JOUR

T1 - Efficacy and cost-effectiveness of a blended cognitive behavioral therapy for depression in Spanish primary health care

T2 - Study protocol for a randomised non-inferiority trial

AU - Dolores Vara, Ma

AU - Herrero, Rocio

AU - Etchemendy, Ernestina

AU - Espinoza, Macarena

AU - Banos, Rosa Ma

AU - Garcia-Palacios, Azucena

AU - Lera, Guillem

AU - Folch, Blanca

AU - Palop-Larrea, Vicente

AU - Vazquez, Pilar

AU - Franco-Martin, Manuel

AU - Kleiboer, Annet

AU - Riper, Heleen

AU - Botella, Cristina

PY - 2018/3/23

Y1 - 2018/3/23

N2 - Background: Data from primary health care in Spain show a high prevalence of the major depressive disorder. Blended treatment (combination of face-to-face and online components) seems to be a very promising tool for the optimization and dissemination of psychological treatments in a cost-effective form. Although there is growing data that confirm the advantages of blended therapies, few studies have analyzed their application in regular clinical practice. The objective of the present paper is to describe the protocol for a clinical study aimed at exploring the clinical and cost-effectiveness of a blended cognitive behavioral therapy (b-CBT) for depression, compared to treatment as usual (TAU) in a primary health care setting. Methods: A two-arm randomised controlled non-inferiority trial will be carried out, with repeated measures (baseline, 3 months, 6 months, and 12 months) under two conditions: b-CBT and TAU. The b-CBT program will consist in three face-to-face sessions and eight online sessions. The TAU is defined as the routine care delivered by the general practitioner for the treatment of depression in primary care. The primary outcome is a symptomatic change of depressive symptoms on the patient-health questionnaire (PHQ-9). Other secondary outcomes will be considered (e.g., quality of life, treatment preference). All participants must be 18 years of age or older and meet the diagnostic criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental disorders 4th edition. 156 participants will be recruited (78 per arm). Discussion: It is expected that b-CBT is clinically non-inferior when compared to TAU. This is the first study in Spain to use a b-CBT format in primary and specialized care, and this format could be an efficacious and cost-effective therapeutic strategy for the treatment of depression.

AB - Background: Data from primary health care in Spain show a high prevalence of the major depressive disorder. Blended treatment (combination of face-to-face and online components) seems to be a very promising tool for the optimization and dissemination of psychological treatments in a cost-effective form. Although there is growing data that confirm the advantages of blended therapies, few studies have analyzed their application in regular clinical practice. The objective of the present paper is to describe the protocol for a clinical study aimed at exploring the clinical and cost-effectiveness of a blended cognitive behavioral therapy (b-CBT) for depression, compared to treatment as usual (TAU) in a primary health care setting. Methods: A two-arm randomised controlled non-inferiority trial will be carried out, with repeated measures (baseline, 3 months, 6 months, and 12 months) under two conditions: b-CBT and TAU. The b-CBT program will consist in three face-to-face sessions and eight online sessions. The TAU is defined as the routine care delivered by the general practitioner for the treatment of depression in primary care. The primary outcome is a symptomatic change of depressive symptoms on the patient-health questionnaire (PHQ-9). Other secondary outcomes will be considered (e.g., quality of life, treatment preference). All participants must be 18 years of age or older and meet the diagnostic criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental disorders 4th edition. 156 participants will be recruited (78 per arm). Discussion: It is expected that b-CBT is clinically non-inferior when compared to TAU. This is the first study in Spain to use a b-CBT format in primary and specialized care, and this format could be an efficacious and cost-effective therapeutic strategy for the treatment of depression.

KW - Blended treatment

KW - Cognitive behavioral therapy

KW - Depression

KW - Internet-based treatment

KW - Primary health care

KW - Randomised non-inferiority trial

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Efficacy and cost-effectiveness of a blended cognitive behavioral therapy for depression in Spanish primary health care: Study protocol for a randomised non-inferiority trial

Abstract

Funding

Keywords

UN SDGs

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