Efficacy of a Guided Web-Based Self-Management Intervention for Depression or Dysthymia: Randomized Controlled Trial With a 12-Month Follow-Up Using an Active Control Condition

Abstract

Background An increasing number of studies suggest that web-based interventions for patients with depression can reduce their symptoms and are expected to fill currently existing treatment gaps. However, evidence for their efficacy has mainly been derived from comparisons with wait-list or treatment as usual controls. In particular, designs using wait-list controls are unlikely to induce hope and may even have nocebo effects, making it difficult to draw conclusions about the intervention’s efficacy. Studies using active controls are rare and have not yielded conclusive results. Objective The main objective of this study is to assess the acute and long-term antidepressant efficacy of a 6-week, guided, web-based self-management intervention building on the principles of cognitive behavioral therapy (iFightDepression tool) for patients with depression compared with web-based progressive muscle relaxation as an active control condition. Methods A total of 348 patients with mild-to-moderate depressive symptoms or dysthymia (according to the Mini International Neuropsychiatric Interview) were recruited online and randomly assigned to 1 of the 2 intervention arms. Acute antidepressant effects after 6 weeks and long-term effects at 3-, 6-, and 12-month follow-up were studied using the Inventory of Depressive Symptomatology–self-rating as a primary outcome parameter and change in quality of life (Short Form 12) and user satisfaction (client satisfaction questionnaire) as secondary outcome parameters. Treatment effects were assessed using mixed model analyses. Results Over the entire observation period, a greater reduction in symptoms of depression (P=.01) and a greater improvement of life quality (P<.001) was found in the intervention group compared with the active control group. Separate tests for each time point revealed significant effects on depressive symptoms at the 3-month follow-up (d=0.281; 95% CI 0.069 to 0.493), but not after 6 weeks (main outcome:d=0.192; 95% CI −0.020 to 0.404) and 6 and 12 months. The intervention was significantly superior to the control condition with respect to user satisfaction (25.31 vs 21.97; t259=5.804; P<.01). Conclusions The fact that antidepressant effects have been found for a guided self-management tool in comparison with an active control strengthens the evidence base for the efficacy of web-based interventions. The antidepressant effect became most prominent at the 3-month follow-up. After 6 weeks of intervention, significant positive effects were observed on life quality but not on depressive symptoms. Although the effect size of such web-based interventions on symptoms of depression might be smaller than that suggested by earlier studies using wait-list control conditions, they can be a cost-effective addition to antidepressants and face-to-face psychotherapy. Trial Registration International Clinical Trials Registry Platform ICTRP080-15-09032015; https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00009323

Intervention Use and Symptom Change With Unguided Internet-Based Cognitive Behavioral Therapy for Depression During the COVID-19 Pandemic: Log Data Analysis of a Convenience Sample

“…As an estimate of symptom change, the mean difference (delta) of PHQ-9 scores at registration and after 6-9 weeks was calculated for all patients with available entries in the category after 6-9 weeks. This time span was used based on experience from a previous study [ 8 ], according to which effects of the intervention were the largest after the sixth week. If patients had filled in PHQ-9 more than once 6-9 weeks after their registration, a mean value was used.…”

“…One of these guided programs is the iFightDepression tool (iFD). It is based on cognitive behavioral therapy (CBT) techniques and its effectiveness has been demonstrated in comparison to an active control group [ 8 ]. Usually, people with depressive disorders receive access to iFD only through their physician or psychotherapist, who then also provides guidance.…”

Effectiveness and acceptance of technology-based psychological interventions for the acute treatment of unipolar depression: a systematic review and meta-analysis (Preprint)

“…Two studies were identified during the search update that could not be matched to our comparisons [ 71 , 94 ]. One study compared a guided web-based CBT tool (iFightDepression) against an active control intervention receiving progressive muscle relaxation provided via a download link [ 71 ]. Another study investigated a TBI in combination with and without transcranial direct current stimulation [ 94 ].…”

Applying the Technology Acceptance Model to Digital Mental Health Interventions: A Qualitative Exploration with Adults with Intellectual Disabilities

“…Central elements of the program focus on moods, workshops incorporating cognitive bheavioural therapy techniques (such as behavioral activation, psychoeducation, and cognitive restructuring). The development of iFightDepression® was supported by the European Alliance Against Depression (EAAD) and has been evaluated in different European countries, with studies indicating positive treatment effects (Königbauer, Letsch, Doebler, Ebert, & Baumeister, 2017;Oehler, Görges, Rogalla, Rummel-Kluge, & Hegerl, 2020).…”