Abstract
BackgroundDepression 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.MethodMulticenter 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.DiscussionLow-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 registrationCurrent Controlled Trials ISRCTN82388279. Registered 16 April 2014.
Highlights
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 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 Information and Communication Technologies (ICTs) in Primary Care settings
Summary
Depression is one of the most common disorders in Psychiatric and Primary Care settings and is associated with significant disability and economic costs. 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. Depression is one of the most common disorders in Psychiatric and Primary Care settings [1] and is associated with significant physical comorbidity [2,3] disability and economic costs [4]. There has been a growing interest and commitment to integrate psychotherapy and other mental health services in Primary Care [14] To date this type of treatment is not being used proportionate in Primary Care. An important goal in Primary Care is that the patient could choose psychological treatment for different reasons: There are patients that would prefer psychotherapy rather than pharmacologic treatment [15,16], and there is a need to offer alternative treatments to the patients that do not respond or respond partially to antidepressants and can benefit from the psychotherapy in terms of costs and relapse prevention [17]
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