Ragne G. H. Gjengedal, Marit Hannisdal, Kåre Osnes, Silje Endresen Rème, Adrian Wells, Roland W. B. Blonk, Hilde Dallavara Lending, Sverre Urnes Johnson, Suzanne E. Lagerveld, Frederick Anyan, Hans M. Nordahl, Romée B T W Gerritsen, Marianne Tranberg Bjørndal, Danielle Wright, Kenneth Sandin, Kjersti Sunniva Bjøntegård, Jørund Schwach, Odin Hjemdal
Background: Employment is a key determinant of health, but mental health treatments have limited success on return-to-work (RTW) in depression and anxiety. We investigated the effectiveness of metacognitive therapy combined with work-focused components (MCT + WF) to improve RTW and reduce anxiety and depression in patients on sick leave. Methods: This single-centre, open-label, randomised controlled trial was conducted at an outpatient clinic (Diakonhjemmet Hospital) in Norway. Eligible patients were adults on sick leave with depression and/or anxiety. Patients with severe mental disorder or substance abuse were excluded. Participants were randomly assigned using computer-generated block randomisation, stratified by gender and percentage of sick leave, to receive either immediate MCT + WF or delayed MCT + WF after 8-12 weeks on a waitlist. Outcome assessors were blinded. Primary outcomes were depression (BDI-II), anxiety (BAI), and RTW at 12 weeks. Sick leave data were obtained from a national registry and self-report; symptoms were self-reported. Analyses followed the intention-to-treat principle, including all randomised participants. This trial was registered with ClinicalTrials.gov, NCT03301922. Findings: = 115). At 12 weeks, logistic regression of registry data showed significantly higher RTW in the immediate MCT + WF group (39%; 47/121) than in the waitlist group (20%; 23/115; OR = 2.39, 95% CI 1.32-4.32; p = 0.0040), consistent with self-reported RTW (42% (51/121) versus 18% (20/114); OR = 3.44, 95% CI: [1.87, 6.35], p < 0.0001). Multilevel models revealed greater reductions in anxiety (time × group interaction coefficient = -8.35, 95% CI -10.61 to -6.09; p < 0.0001) and depression (-10.84, 95% CI -13.25 to -8.44; p < 0.0001) for immediate MCT + WF versus waiting. No serious adverse events were reported during the study. Interpretation: Immediate MCT + WF significantly improved RTW and reduced symptoms of depression and anxiety compared with waiting. Generalisability may be constrained by Norway's welfare system; strengths include registry data and naturalistic outpatient setting. The favourable outcomes suggest that MCT + WF could be integrated into mental health care. Funding: The study was funded by the South-Eastern Norway Regional Health Authority and DAM foundation-Mental Health, Diakonhjemmet Hospital.