Differential Efficacy of an Internet Delivered Intervention Program for the Prevention and Treatment of Mild to Moderate Depression With or Without Support by the Therapist

Brief Summary

Detailed Description

It is know that 25% of all human beings will suffer from depression at any moment over their lives and it will become one of the three leading causes of disability in 2030 (Mathers and Loncar, 2006). A very important challenge today consists on addressing the issue of depression from a preventive perspective (Mihalopoulos and Vos, 2013) operating in each of its three levels: primary prevention, to reduce its incidence, secondary prevention, for people who have some risk factor or those who show subclinical symptoms, and tertiary prevention, to minimize the limitations caused by an already established disorder (Commission on Chronic Illness, 1957; Vazquez and Torres, 2007). As Cuijpers, Beekman et al. (2012) point out in a recent paper, it is important to develop better strategies and tools to identify individuals at risk and the design of prevention programs. The investigators have evidence based psychological treatments for depression (Nathan and Gorman, 2007) and, although less there are also interventions focusing on its prevention (Cuijpers et al., 2008, Horowitz y Garber, 2006; Muñoz et al., 2010). However, they have an important limitation: the provision of mental health services is generally less than adequate in terms of accessibility and quality (Hinrichsen, 2010, Institute of Medicine, 2008; Kazdin and Blase, 2011). The Information and Communication Technologies (ICTs), especially the use of the Internet to support the implementation of the interventions (treatment or prevention), have proven to be a powerful means for its effective deployment in general mental healthcare provision. Although data using Internet-based interventions are consistent and promising, there are still important problems to solve: not all patients continue and complete these programs. The meta-analysis of studies on Internet-based treatments for depression report a dropout rate of 32% (range 0-75%) (Kaltenthaler, Parry, Beverley and Ferriter, 2008; Melville, Casey and Kavanagh, 2010). This problem could have various causes and one of which may be the fact of providing or not human support (Andersson et al., 2009). Recently, there has been increased research to determine the importance of human support in such interventions (Richards y Richardsson, 2012; Hilvert-Bruce, Rossouw, Wong, Sunderland and Andrews, 2012). The studies of meta-analysis find that the Internet-based treatments, in which support is given throughout the implementation of the program, produce greater effect sizes and less dropout rates than Internet-based programs without any human support (Andersson and Cuijpers, 2009; Richards and Richardson, 2012). It is important to note that the majority of studies mean support when it is administered by a person (therapist, consultant or researcher) and not by the ICTs (automated reminders, e-mails or mobile SMS) (Richards and Richardson, 2012). Now, there has also been recent evidence of the effectiveness of the self-applied treatments without any contact or support from a therapist, consultant or researcher (Cuijpers, Donker et al, 2011). Nevertheless, there are still few randomized controlled trials that specifically examine this issue (Berger et al., 2011, Clarke et al, 2005; Farrer, Christensen, Griffiths and Mackinnon, 2011). This is the principal objective of the present work, given the importance that this may have for the future developments in this field. The investigators addressed: It is necessary a weekly support call from a therapist during the course of an Internet- based intervention program, or is it enough just the support of the ICTs?. Because of this, the investigators have developed an Internet-based program (Smiling is Fun) for the prevention and treatment of depression (mild to moderate), and have carried out a randomized controlled trial with three experimental conditions: a) Intervention group with human support (two minutes weekly support call without clinical content); b) Intervention group without human support; c) Waiting list control condition. The two intervention groups received automated support from the ICTs: two weekly automated mobile phone messages, reminding of the importance of doing the tasks proposed by the program and, an automated e-mail encouraging them to continue with the modules in case they have not accesses the program for a week. The principal hypothesis is that the two intervention groups will improve significantly compared to the waiting list control group, and without significant differences among themselves. The investigators believe that the support of ICTs may be doing a similar function as the weekly support call (to offer feedback, to reinforce, to motivate the participants, etc.). Furthermore the investigators hypothesize that the intervention program will be a useful tool for a secondary and tertiary prevention of depression.

Primary Outcomes

Secondary Outcomes

• Change from Positive and Negative Affect Scale (PANAS) at 3, 6 and 12 months follow-ups(Up to 12 months)
• Change from Overall Anxiety Severity and Impairment Scale (OASIS) at 3, 6 and 12 months follow-ups(Up to 12 months)
• Change from Overall Depression Severity and Impairment Scale (ODSIS) at 3, 6 and 12 months follow-ups(Up to 12 months)