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Randomized Controlled Trial
. 2015 May 7:15:106.
doi: 10.1186/s12888-015-0475-0.

Efficacy of low-intensity psychological intervention applied by ICTs for the treatment of depression in primary care: a controlled trial

Adoración Castro  1   2 , Azucena García-Palacios  3   4 , Javier García-Campayo  5   6 , Fermín Mayoral  7 , Cristina Botella  8   9 , José María García-Herrera  10 , Mari-Cruz Pérez-Yus  11 , Margalida Vives  12   13 , Rosa M Baños  14   15 , Miquel Roca  16   17 , Margalida Gili  18   19
Affiliations
Randomized Controlled Trial

Efficacy of low-intensity psychological intervention applied by ICTs for the treatment of depression in primary care: a controlled trial

Adoración Castro et al. BMC Psychiatry. .

Abstract

Background: Depression is one of the most common disorders in Psychiatric and Primary Care settings and is associated with significant disability and economic costs. Low-intensity psychological interventions applied by Information and Communication Technologies (ICTs) could be an efficacious and cost-effective therapeutic option for the treatment of depression. The aim of this study is to assess 3 low-intensity psychological interventions applied by ICTs (healthy lifestyle, positive affect and mindfulness) in Primary Care; significant efficacy for depression treatment has previously showed in specialized clinical settings by those interventions, but ICTs were not used.

Method: Multicenter controlled randomized clinical trial in 4 parallel groups. Interventions have been designed and on-line device adaptation has been carried out. Subsequently, the randomized controlled clinical trial will be conducted. A sample of N = 240 mild and moderate depressed patients will be recruited and assessed in Primary Care settings. Patients will be randomly assigned to a) healthy lifestyle psychoeducational program + improved primary care usual treatment (ITAU), b) focused program on positive affect promotion + ITAU c) mindfulness + ITAU or d) ITAU. The intervention format will be one face to face session and four ICTs on-line modules. Patients will be diagnosed with MINI psychiatric interview. Main outcome will be PHQ-9 score. They will be also assessed by SF-12 Health Survey, Client Service Receipt Inventory, EuroQoL-5D questionnaire, Positive and Negative Affect Scale, Five Facet Mindfulness Questionnaire and the Pemberton Happiness Index. Patients will be assessed at baseline, post, 6 and 12 post-treatment months. An intention to treat and per protocol analysis will be performed.

Discussion: Low-intensity psychological interventions applied by Information and Communication Technologies have been not used before in Spain and could be an efficacious and cost-effective therapeutic option for depression treatment. The strength of the study is that it is the first multicenter controlled randomized clinical trial of three low intensity and self-guided interventions applied by ICTs (healthy lifestyle psychoeducational program; focused program on positive affect promotion and brief intervention based on mindfulness) in Primary Care settings.

Trial registration: Current Controlled Trials ISRCTN82388279 . Registered 16 April 2014.

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Figures

Figure 1
Figure 1
Flowchart of the study: Randomization, sampling and monitoring of patients.
See this image and copyright information in PMC

References

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