Research paperComputerized cognitive behavior therapy for patients with mild to moderately severe depression in primary care: A pragmatic cluster randomized controlled trial (@ktiv)
Introduction
Depression is a common and highly impairing disorder. In Europe, prevalence rates for depression in a 12-month period were found to be 7% and conservative estimates of lifetime prevalence of depression are calculated at 14% (Wittchen et al., 2011). For individuals with depressive disorders, functioning in social, familial, and work roles is compromised, and the burden on societies is staggering (Luck et al., 2017); the World Health Organization (WHO) lists depression as the leading cause of disability worldwide (World Health Organization, 2017).
General practitioners (GPs) play an important role in the treatment of depressive disorders. Studies of help-seeking behavior identified GPs as the first health care professional for patients with depressive symptoms (Riedel-Heller et al., 2005). However, when it comes to accessing specialist care, there are barriers to treatment such as long waiting periods for psychotherapeutic or psychiatric services, lack of providers in underserviced areas, and fear of stigma. A US study found that only about 57% of 12-months depression cases actually received some type of treatment in the past year (Kessler et al., 2003).
Computerized support strategies provide a good framework for delivering prompt, easily accessible treatment for individuals with depressive disorders. A number of systematic reviews and meta-analyses have shown that computerized cognitive behavior therapy (cCBT) provides a clinically effective intervention strategy for treating depression, with larger effects in programs with professional support or guidance (Andrews et al., 2010, Griffiths et al., 2010, Sikorski et al., 2011, Andrews et al., 2018). However, most studies have been conducted in academic and non-clinical settings where participants were recruited either via advertisements or by an epidemiological screening approach (Andersson and Cuijpers, 2009). Although recognized as the most important setting to identify and initiate depression treatment, few studies have recruited patients from primary care, yielding mixed results. For example, Proudfoot and colleagues (Proudfoot et al., 2004) demonstrated the effectiveness of cCBT (Beating the Blues) in a UK sample of 274 adult primary care patients with anxiety and/or depression, who were followed at two, three, four and eight months after baseline. They found a decline in BDI-II scores, which was stronger for the cCBT group than for the control group. An Australian study (Hickie et al., 2010) investigated a GP supported cCBT program (moodgym). This small cluster randomized controlled trial investigated 83 patients with moderate to high psychological distress and encountered substantial feasibility constraints. Nonetheless, the authors showed the effectiveness of using cCBT in conjunction with GP care; intervention patients exhibited a reduction of depressive symptoms as compared to control patients. The recently conducted REEACT trial (Gilbody et al., 2015) challenged the promising results of these trials, by showing that adjunct supported cCBT did not improve depression outcomes in primary care.
More recently, a meta-analysis (Twomey and O'Reilly, 2017) of available moodgym studies showed an overall small effect size of the program (g = 0.36) across 11 studies conducted between 2008 and 2015, which was rendered no longer significant when adjusting for publication bias (g = 0.17). Results were confounded by the level of clinician guidance, country of the trial and adherence to cCBT. Still, the authors conclude that there is tentative support for the effectiveness of moodgym with regard to reducing symptoms of depression and general psychological distress. In addition, using moodgym with some degree of face-to-face support yielded higher effect sizes. With regard to the practical benefits of cCBT further research is needed with regard to the optimal balance between the level of guidance and self-management.
Taken together, the potential of cCBT as treatment option within primary care still remains an open question. Furthermore, little is known about the acceptability of cCBT for the treatment of depression in primary care (Kaltenthaler et al., 2008). The @ktiv trial was designed to investigate the effectiveness and acceptability of a self-guided cCBT program (German moodgym) as adjunct to usual primary care for patients with mild to moderately severe depressive symptoms.
Section snippets
Study design
The @ktiv trial is a parallel group, cluster randomized controlled trial in the primary care setting with general practices serving as clustering variable. General practitioners from registered practices in three German federal states (Saxony, Saxony-Anhalt, and Thuringia) were invited to take part in the study. Assessments in both the intervention group (IG) and the control group (CG) took place at baseline, after six weeks and after six months.
Recruitment
All participating GPs were fully informed about
Patient flow
Of the 4840 general practices that were contacted, 190 practitioners provided written informed consent and were randomized to either IG (N = 95) or CG (N = 95) (Fig. 1). Of those, a total of N = 112 practices recruited patients for the study (IG (N = 65) and CG (N = 47). The median number of recruited patients was three (IQR 1–6). Recruitment of patients took place from February 1, 2014 to August 31, 2015. GPs recruited a final total of 647 patients for the @ktiv trial, in almost equal parts
Principal results
The @ktiv trial shows that primary care patients with symptoms of mild to moderately severe depression benefited from augmenting usual care with GP supported self-guided cCBT. Participants with access to moodgym experienced a more pronounced decline in depression symptoms measured by the BDI-II and the PHQ-9 at six months, as compared to patients receiving usual care only. In addition, we observed a small benefit for cCBT on depression (BDI-II) at six weeks. Results of the secondary analysis
Trial registration
German Clinical Trials Register (number DRKS00005075).
Conflict of interest
All authors have completed and signed the ICMJE uniform disclosure form and declare that: The Institute of Social Medicine, Occupational Health and Public Health (ISAP) and the Department of Health Economics and Health Services Research (IGV) had a research grant from the Federal Association of AOK for conducting the @ktiv trail; no competing interests related to the submitted work were reported by SRH, AP, MLö, MD, ML, HM, and JS; AM is an employee of the Federal Association of AOK that
Funding
The @ktiv trial was partly funded by the Federal Association of AOK (Project number BGAAF-0608) and published in affiliation with the German Federal Ministry of Education and Research (grant number: 01GY1613). The funder of the study contributed to the trial design, but had no role in patient recruitment and in conducting the trial including collection, analysis and interpretation of the data.
Acknowledgments
We thank the @ktiv participants for their valuable contribution to this study, and we extend our thanks also to the GPs and support staff at all GP practices. We also would like to thank the moodgym developers for providing us with pseudonymised user logins and usage data. Finally, we thank Lisa Wittenburg for proofreading the manuscript.
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