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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.
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.
Studies on the potential benefits of conveying biofeedback stimulus using a musical signal have appeared in recent years with the intent of harnessing the strong effects that music listening may have on subjects. While results are encouraging, the fundamental question has yet to be addressed, of how combined music and biofeedback compares to the already established use of either of these elements separately. This experiment, involving young adults (N = 24), compared the effectiveness at modulating participants' states of physiological arousal of each of the following conditions: A) listening to pre-recorded music, B) sonification biofeedback of the heart rate, and C) an algorithmically modulated musical feedback signal conveying the subject's heart rate. Our hypothesis was that each of the conditions (A), (B) and (C) would differ from the other two in the extent to which it enables participants to increase and decrease their state of physiological arousal, with (C) being more effective than (B), and both more than (A). Several physiological measures and qualitative responses were recorded and analyzed. Results show that using musical biofeedback allowed participants to modulate their state of physiological arousal at least equally well as sonification biofeedback, and much better than just listening to music, as reflected in their heart rate measurements, controlling for respiration-rate. Our findings indicate that the known effects of music in modulating arousal can therefore be beneficially harnessed when designing a biofeedback protocol.
Vive provides a fully immersive virtual reality meditation-focused experience.
Vive provides a fully immersive virtual reality meditation-focused experience.