Efficacy of an Online Self-Help Programme with Automated or Individualised Psychological Support Versus Treatment As Usual for Caregivers of People with Depression: a Randomised, Controlled, Open-Label, Superiority Trial

Background:Informal caregivers of depressed individuals often report extensive psychological distress with detrimental consequences for their own health and for the course of the depressed person's disease. An online self-help programme was developed involving focus groups of caregivers, affected individuals and clinical experts. Methods:In this randomised, controlled, open-label superiority trial with three parallel groups (prospective registration: DRKS00025241), stratified randomisation allocated caregivers (≥18 years) of depressed individuals in a 2:2:1 ratio to receiving the programme with either individualised (IND, three weekly e-mails by trained psychologists) or automated (AUT) support messages, or to treatment as usual (TAU; information material, no online programme, no messages). The primary outcome was the change from baseline to four weeks after randomisation in the Kessler Psychological Distress Scale (K-10). Findings:The trial was conducted between 01 March 2020 and 29 February 2024. In 1640 (IND: n = 651; AUT: n = 659; TAU: n = 330) caregivers (mean[SD] age m age = 42·8 [12·89] years; n = 1300 [79%] female; baseline K-10 score m K-10 = 23·4 [6·09]), both IND and AUT reduced psychosocial distress significantly more than TAU at four weeks after randomisation (adjusted difference m IND/TAU [95%-CI] = -1·45 [-2·19,-0·72], p = 0·0001; m AUT/TAU [95%-CI] = -0·89 [-1·63,-0·14], p = 0·0205; dropout rate: 34%, n = 562). No study-related harms were reported. Interpretation:Psychological online support for caregivers of depressed individuals with either individualised or automated messages is effective in decreasing their psychosocial distress and could be offered as part of integrated services. Funding:German Innovation Fund (Federal Joint Committee, 01VSF19054).