Research reportInternet-based versus face-to-face cognitive-behavioral intervention for depression: A randomized controlled non-inferiority trial☆
Introduction
Depression is a one of the most common mental disorders among adults. It is associated with significant impairments in health and functional status, as well as with high economic and personal costs (Andrews et al., 2001). The early age of onset, high prevalence rate and often long-term nature of depression make it a major public health problem that generates large direct and indirect costs for the depressed person as well as for society (Richards, 2011). In Europe for the year 2010 the annual cost of depression per patient was estimated at €3034 with an estimated number of 30.3 million people affected (Olesen et al., 2012). These costs are incurred despite the fact that the vast majority of people suffering from depression do not access treatment (Collins et al., 2004). Barriers to assessing effective treatment include fear of stigma, lack of time, long waiting times, geographic distance to mental health services, or unwillingness to disclose psychological problems (Collins et al., 2004). Internet-based interventions may help to overcome these obstacles. Andersson and Cuijpers found a strong influence of therapist support on treatment outcome in their 2009 meta-analysis of 12 internet-based randomized controlled trials for depression, (Andersson and Cuijpers, 2009). Computerized interventions with therapist support showed a mean between-group effect size of d=.61, which is comparable with face-to-face treatment for depression, whereas interventions with little or no therapist contact had significantly smaller treatment effect sizes, averaging d=.25. A recently published meta-analysis, including data from 25 controlled trials, supports these previous findings and found effect sizes ranging from d=.10 to d=1.20 (Johansson and Andersson, 2012). The authors categorized the studies by type of human contact. Category 0 was used for no human contact at all throughout the treatment, category 1 for therapist contact only before treatment, category 2 was contact only during the treatment and finally category 3 was where therapist contact took place before, during and after the intervention. The effect sizes were d=.21, .44, .56 and .76. These results indicate that higher levels of human contact yield larger effect sizes. This matches other findings of a significant correlation between the amount of therapist time in minutes per participant and the between-group effect sizes of internet-based interventions (Palmqvist et al., 2007). Moreover, studies on entirely self-guided programs have shown not only reduced treatment effects, but also substantial attrition rates of up to 41% (Christensen et al., 2006a, Christensen et al., 2006b, Clarke et al., 2005, Clarke et al., 2002, Kaltenthaler et al., 2008). In summary, it can be concluded that therapist-assisted online programs for depression yield medium to large effect sizes.
However the question remains of whether internet-based therapies for depression are equally as beneficial for patients as standard face-to-face treatments. Only a few studies have directly compared computerized interventions with face-to-face interventions. Spek and colleagues evaluated an 8 week internet-based intervention for non-typical subthreshold depression in people aged 50 and older compared to 10 weekly face-to-face group sessions and a waiting-list condition (Spek et al., 2007). No significant treatment effect differences were found between the face-to-face group intervention and the internet-based intervention. Other studies have evaluated and compared online versus face-to-face therapies for tinnitus (Kaldo et al., 2008), social phobia (Andrews et al., 2011), panic disorder (Bergstrom et al., 2010), spider phobia (Andersson et al., 2009), and relaxation (Carlbring et al., 2007) and found no significant differences between the two settings. Only one study, evaluating an intervention for body image and eating disorders, showed a significant difference between the two groups (Paxton et al., 2007). Post-treatment improvements were larger in the face-to-face than in the internet-based intervention. Although there is mounting evidence that internet-based interventions for depression are effective and there is support for the assumption that therapist guided interventions are favorable over unguided interventions, to our knowledge, no randomized controlled trial for depression has been conducted to compare treatment efficacy in the two treatments (online vs. face-to-face) in an experimental setting.
Recognizing that time-intensive psychotherapies present an important barrier to mental health care use, the present study used non-inferiority methodology to compare the efficacy of a brief 8-week internet-based CBT intervention with high therapist involvement for depression with a face-to-face CBT intervention. The Internet-based intervention was not self-guided and the treatment consisted of structured writing assignments with an individualized feedback from the therapist. The treatment manual was based on a German CBT treatment manual for depression (Hautzinger, 2003). Patients from both groups received the same course of treatment over the same timeframe and the time of contact between therapist and patient was equal for both groups. Primary outcomes of the study were depression, secondary symptoms, anxiety, general health, and depression-related outcomes (e.g. suicidal ideation, hopelessness and negative automatic thoughts). It was predicted that participants in both groups would have significant reduced symptoms of depression after treatment and that the improvements would be maintained at a 3-month follow-up assessment. Further, it was hypothesized that the groups would not differ significantly at either post-treatment or 3-month follow-up for both primary and secondary outcomes.
Section snippets
Ethics statement
Ethical approval for the trial was given by the institutional review board at the University of Zurich. Signed informed consent was given by all participants by fax or post. The protocol for this trial and supporting CONSORT checklist are available as supporting information; see Checklist S1 and Protocol S1.
Participants and recruitment
Potential participants were recruited in the area of Zurich, Switzerland, through advertisements in newspapers, the depression website of the university, local internet news forums and
Results
Table 1 shows baseline sociodemographic characteristics of participants in the online and face-to-face conditions. There were no significant differences for most of the baseline variables, however, despite randomization, there was a significantly higher percentage of women in the online group (78%) versus 50% in the face-to-face group, χ2 (1)=5.35, p<.05. The BDI baseline score was M=22.96 (S.D.=6.07) for the online group and M=23.41 (S.D.=7.63) for the face-to-face group. Symptom severity was
Discussion
The aim of this non-inferiority randomized controlled trial was to test an internet-based intervention against a comparable, traditional face-to-face therapy for depression. To our knowledge this is the first randomized controlled trial for depression comparing both treatment forms with equivalent treatment modules and treatment length. We assumed equal effects for the two conditions. The main finding of this trial is that the internet-based intervention is indeed equally as effective as
Conclusion
Depression has become a very prevalent und costly disorder and in most countries therapeutic services do not manage to meet the needs presented by this growing demand. This trial gives preliminary results that a brief internet-based intervention for depression is as effective as comparable face-to-face interventions. Internet-based intervention may be the solution for tackling this epidemic in a more cost-effective way than traditional face-to-face therapies. However, further research is needed
Role of funding source
This research was supported by the Selo Foundation, Switzerland.
Conflict of interest
The authors declare no conflict of interest.
Acknowledgments
The authors would like to thank Barbara Preschl, Jenni Keel, Luigina Di Lorenzo, and Regula Usteri, who served as therapists in the study. This study was co-funded by the Werner Selo Foundation.
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Trial registration: Australian New Zealand Clinical Trial Registry: ACTRN12611000563965.