Testing the Efficacy of a Web-Based Intervention for Loss and Bereavement in Later Life (AgE-health Study): Results From a Randomized Controlled Trial (Preprint)

<sec> <title>BACKGROUND</title> The loss of a loved one is a common yet stressful event in later life. Internet- and mobile-based interventions have been proposed as an effective treatment approach for individuals with prolonged grief. </sec> <sec> <title>OBJECTIVE</title> The AgE-health study aimed to investigate the efficacy of an eHealth intervention, trauer@ktiv, in reducing prolonged grief symptoms in a sample of older adults. The trauer@ktiv intervention is an unguided, web-based self-management intervention based on cognitive behavioral therapy principles, addressing grief in later life. </sec> <sec> <title>METHODS</title> The AgE-health study was designed as a randomized controlled trial with an active control group (CG). Recruitment and data assessment took place between October 2020 and September 2022. A sample of 177 older adults (aged ≥60 years) with prolonged grief symptoms was randomly assigned to the intervention group (IG; access to the trauer@ktiv eHealth intervention) or the active CG (access to an information brochure on loss and grief). Participants were interviewed at 2 time points, before and after accessing the intervention, via postal questionnaires (baseline and follow-up 4 months after the intervention). The primary outcome was the reduction in prolonged grief symptoms assessed with the Prolonged Grief-13 scale. Adjusted mixed-effects regression models were used to test for changes in primary and secondary outcomes (eg, depression and self-efficacy) as part of an intention-to-treat (ITT) analysis. The study procedure was described in detail in the study protocol. </sec> <sec> <title>RESULTS</title> From baseline to 4 months after the intervention, 7 participants were lost to follow-up. Final analyses included a sample of 170 individuals (IG: n=81, 47.6%; CG: n=89, 52.4%). The study population had an average age of 67.3 (SD 6.4; range 60-95) years and consisted predominantly of female participants (129/170, 75.9%). While there was a pre-post-reduction in persistent grief symptoms, the ITT analysis showed no significant differences between IG and CG at follow-up (Prolonged Grief-13 scale, average marginal effect of 0.56, 95% CI –2.30 to 3.44, &lt;i&gt;P&lt;/i&gt;=.70). Similarly, the ITT analysis showed no significant treatment effects for any of the secondary outcomes at follow-up. The trauer@ktiv intervention was rated high on satisfaction and usability. More than half of the IG (49/81, 61%) completed 5 or more of the 8 modules of the eHealth intervention. </sec> <sec> <title>CONCLUSIONS</title> The tested eHealth intervention, trauer@ktiv, showed no superiority compared to an active CG in reducing prolonged grief symptoms in a sample of older bereaved individuals. Therefore, trauer@ktiv is not suitable as a stand-alone treatment. However, as the ease of use and satisfaction with the application were high, there may be potential for the intervention within a stepped and collaborative treatment approach. </sec> <sec> <title>CLINICALTRIAL</title> German Clinical Trials Register DRKS00020595; https://drks.de/search/de/trial/DRKS00020595 </sec> <sec> <title>INTERNATIONAL REGISTERED REPORT</title> RR2-10.1016/j.invent.2021.100451 </sec>