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Original Investigation |

Effect of a Web-Based Guided Self-help Intervention for Prevention of Major Depression in Adults With Subthreshold Depression A Randomized Clinical Trial

Claudia Buntrock, MSc1,2; David Daniel Ebert, PhD1,3; Dirk Lehr, PhD1; Filip Smit, PhD2,4,5; Heleen Riper, PhD1,2,6; Matthias Berking, PhD1,3; Pim Cuijpers, PhD1,2
[+] Author Affiliations
1Division of Online Health Training, Innovation Incubator, Leuphana University Lueneburg, Germany
2Department of Clinical Psychology, EMGO+ Institute for Health and Care Research, VU University, Amsterdam, the Netherlands
3Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander-University, Erlangen-Nuremberg, Germany
4Department of Public Mental Health, Trimbos Institute (Netherlands Institute of Mental Health and Addiction), Utrecht
5Department of Epidemiology and Biostatistics, EMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, the Netherlands
6Institute of Telepsychiatry, University of Southern Denmark, Odense
JAMA. 2016;315(17):1854-1863. doi:10.1001/jama.2016.4326.
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Importance  Evidence-based treatments for major depressive disorder (MDD) are not very successful in improving functional and health outcomes. Attention has increasingly been focused on the prevention of MDD.

Objective  To evaluate the effectiveness of a web-based guided self-help intervention for the prevention of MDD.

Design, Setting, and Participants  Two-group randomized clinical trial conducted between March 1, 2013, and March 4, 2015. Participants were recruited in Germany from the general population via a large statutory health insurance company (ie, insurance funded by joint employer-employee contributions). Participants included 406 self-selected adults with subthreshold depression (Centre for Epidemiologic Studies Depression Scale score ≥16, no current MDD according to Diagnostic and Statistical Manual of Mental Disorders [Fourth Edition, Text Revision] criteria).

Interventions  All participants had unrestricted access to usual care (visits to the primary care clinician) and were randomized to either a web-based guided self-help intervention (cognitive-behavioral and problem-solving therapy supported by an online trainer; n = 202) or a web-based psychoeducation program (n = 204).

Main Outcomes and Measures  The primary outcome was time to onset of MDD in the intervention group relative to the control group over a 12-month follow-up period as assessed by blinded diagnostic raters using the telephone-administered Structured Clinical Interview for DSM-IV Axis Disorders at 6- and 12-month follow-up, covering the period to the previous assessment.

Results  Among 406 randomized patients (mean age, 45 years; 73.9% women), 335 (82%) completed the telephone follow-up at 12 months. Fifty-five participants (27%) in the intervention group experienced MDD compared with 84 participants (41%) in the control group. Cox regression analyses controlling for baseline depressive symptom severity revealed a hazard ratio of 0.59 (95% CI, 0.42-0.82; P = .002) at 12-month follow-up. The number needed to treat to avoid 1 new case of MDD was 5.9 (95% CI, 3.9-14.6).

Conclusions and Relevance  Among patients with subthreshold depression, the use of a web-based guided self-help intervention compared with enhanced usual care reduced the incidence of MDD over 12 months. Further research is needed to understand whether the effects are generalizable to both first onset of depression and depression recurrence as well as efficacy without the use of an online trainer.

Trial Registration  German Clinical Trial Registry Identifier: DRKS00004709

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Figure 1.
Assessment, Randomization, and Follow-up of Study Participants With Subthreshold Depression

Adapted from Buntrock et al.30 CES-D indicates Centre for Epidemiological Studies Depression Scale; MDD, major depressive disorder; SCID, Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) Axis Disorders.

aAdherence to the intervention could not be assessed.

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Figure 2.
Kaplan-Meier Survival Estimates of Time to Onset of Major Depressive Disorder by Study Group

The primary end point was time to onset (in weeks) of a major depressive disorder in the intervention relative to the control group according to Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) Axis Disorders criteria. Follow-up time was truncated at 52 weeks. The log-rank test and Cox proportional hazard regression analysis controlling for baseline depressive symptom severity were used to test for group differences. HR indicates hazard ratio. The shaded areas illustrate 95% CIs.

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