| Popis: |
Background. Depression treatments are typically less effective for young people than for adults. However, extant treatments rarely target loneliness, which is a key risk factor in the onset, maintenance, and development of depression. Aims. This study evaluated the efficacy of a novel loneliness intervention, GROUPS 4 HEALTH (G4H), relative to best-practice treatment Cognitive Behaviour Therapy (CBT) in reducing loneliness and depression over a 12 month period. Methods. The study was a Phase 3, randomised non-inferiority trial comparing G4H to dose-controlled group CBT. Participants were 174 young people aged 15-25 years experiencing loneliness and clinically significant symptoms of depression, who were not in receipt of adjunct treatment. Participants were recruited from mental health services in Southeast Queensland, Australia. Randomisation was conducted using computer software. Follow-up assessments and statistical analyses were blind to allocation. Both interventions consisted of 5 x 75 min group-based psychotherapy sessions. The primary outcomes were depression and loneliness, with a non-inferiority margin of 2.20 for depression. The trial was prospectively registered on the Australian New Zealand Clinical Trial Registry (ACTRN12618000440224) on 27 March 2018 and is closed to new participants. Results. 174 participants were enrolled between 24 April 2018 and 25 May 2019, with 84 in the G4H condition and 90 in the CBT condition. All randomised participants were included in the intention-to-treat analyses (N=174). The pre-post effect sizes for depression were d=-.71G4H and d=-.91CBT. For loneliness, they were d=-1.07G4H and d=-0.89CBT. At 12-month follow-up, the absolute difference between groups in depression was 1.176 (95%CI: -1.94, 4.29), and in loneliness was -0.679 (95%CI: -.1.43, .07). No adverse effects were observed. Conclusions. G4H was non-inferior to CBT for depression and showed a slight advantage over CBT for loneliness that emerged after treatment completion. |
