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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UR - http://www.scopus.com/inward/citedby.url?scp=85044314052&partnerID=8YFLogxK
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85044314052&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/29566656
U2 - https://doi.org/10.1186/s12888-018-1638-6
DO - https://doi.org/10.1186/s12888-018-1638-6
M3 - Article
C2 - 29566656
SN - 1471-244X
VL - 18
SP - 1
EP - 9
JO - BMC psychiatry
JF - BMC psychiatry
IS - 1
M1 - 74
ER -
