Internet Delivered Intervention Program for the Prevention and Treatment of Depression
Condition: Internet-based Treatment for Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to determine the differential effectiveness of a self applied
      treatment delivered via Internet for the prevention and treatment of depression, with or
      without support by the therapist, compared to a waiting list control group. The principal
      hypothesis is that the two intervention groups will improve significantly compared to the
      waiting list control group, and without significant differences between them. 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.
    

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.
    

Intervention name(s): Smiling is Fun
Intervention type(s): Behavioral
Intervention description(s): Smiling is Fun is an internet-delivered self-help program for emotional disorders, which will allow the individual to learn and practice adaptive ways to cope with depression and daily problems. The program includes eight modules: Motivation for change, Understanding emotional problems; Learning to move on; Learning to enjoy; Learning to live; Living and learning and From now on, what else…?. Furthermore the program uses three transversal tools: 1) Activity report for self-monitoring, whose aim is to provide feedback to the user and help him see that his mood is related to the activities performed, 2) The calendar, and 3) "How am I?" offers a set of graphs and feedbacks to chart the user's progress.
Other intervention name(s): Coping withs stress; Emotion Regulation Program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression; Self-applied treatment; Internet; Support by the therapist; Cognitive-Behavioural Treatment; Positive Psychology; Behavioral Activation