A pilot randomized controlled trial of E-care for caregivers: An internet intervention for caregivers of depressed patients

Background:Depression has a high impact on both patients and the people around them. These non-professionalcaregivers often experience overburdening and are at risk for developing psychological symptoms themselves.Internet interventions have the potential to be accessible and (cost)-effective in terms of reducing and preventingpsychological symptoms. Less is known about their potential to decrease psychological distress among care-givers. The primary aim of this study is to evaluate (1) the user-friendliness and (2) the initial short-term effectson psychological distress of‘E-care for caregivers’, an internet based guided self-management intervention fornon-professional caregivers of depressed patients.Methods:A pilot randomized controlled trial (RCT:n= 80) comparing‘E-care for caregivers’(n= 41) with awaitlist-control group (n= 39). The primary outcome measure (user-friendliness) was assessed with the SystemUsability Scale (SUS) and semi-structured telephone interviews among participants. Interviews were qualita-tively analyzed with thematic content analysis. Secondary outcomes were assessed through online ques-tionnaires administered at baseline and post-intervention at six weeks among caregivers. Statistical analyseswere conducted according to the intention-to-treat principle using regression techniques for the secondaryoutcomes.Results:All participants were recruited within six weeks through online advertising. Two-thirds of participantsexperienced higher levels of psychological distress (K10 > 20). The internet intervention was evaluated as user-friendly by caregivers (average score of 81.5, range [0–100]). Results did not show a reduction in psychologicaldistress or other secondary outcome measures. Sensitivity analyses showed a decreased quality of life in thecontrol condition compared to the intervention condition (p= 0.02, Cohen's d = 0.44) and higher levels ofmastery (p= 0.02, Cohen's d = 0.48) in the intervention condition compared to controls.Discussion:The internet intervention was evaluated positively for usability and was considered as easy to use.The study did not show a reduction in symptoms of psychological distress. However, there were some indicationsthat those completing the internet intervention perceived higher levels of mastery and a protective effect inquality of life post-intervention.Strengths and limitations:As far as we know, this study is thefirst to examine the user-friendliness and initialeffects of an internet intervention specifically designed for non-professional caregivers of depressed patients. Asthis was a pilot study, thefindings should be interpreted with caution. We recommend investigating the pos-sibilities of providing a (partially) sequential design as well as incorporating themes like stigma and expressedemotion in the online course and subsequent evaluation of the internet intervention in a full-scale RCT, with asix-month follow-up.Trial registration:Netherlands Trial Register: NTR5268. Registered on 30 June 2015