Craig Steel1, Kees Korrelboom2, M Fazil Baksh3, David Kingdon4, Judit Simon5, Til Wykes6, Peter Phiri7, Mark van der Gaag8. 1. Oxford Health NHS Foundation Trust, Oxford, UK; School of Psychology, University of Reading, UK. Electronic address: craig.steel@hmc.ox.ac.uk. 2. Department of Anxiety Disorders, PsyQ Parnassia Group, Psychiatric Center, The Hague, the Netherlands; Department of Medical and Clinical Psychiatry, Tilburg University, Tilburg, the Netherlands. 3. Department of Mathematics and Statistics, University of Reading, Whiteknights, Reading, RG6 6AL, UK. 4. University of Southampton, Highfield, Southampton, SO17 1BJ, UK. 5. Department of Health Economics, Center for Public Health, Medical University of Vienna, 1090, Wien, Kinderspitalgasse 15, Austria; Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford OX3 7JX, UK. 6. Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, London, UK. 7. Southern Health NHS Foundation Trust, Research & Development Department, Tom Rudd Unit, Moorgreen Hospital, Botley Rd, West End Southampton, SO30 3JB, UK. 8. VU University and Amsterdam Public Mental Health Research Institute, Department of Clinical Psychology Van der Boechorststraat 1, 1081, BT, Amsterdam, the Netherlands; Parnassia Psychiatric Institute, Zoutkeetsingel 40, 2512, HN, The Hague, the Netherlands.
Abstract
BACKGROUND: Around half of people diagnosed with schizophrenia suffer from co-morbid depression, yet there are no evidence-based psychological treatments to target this presentation. METHOD: Participants were aged 18-65 years old, had a clinical diagnosis of schizophrenia or schizoaffective disorder and at least a mild level of depression. Participants were randomly assigned (1:1) to receive PoMeT or treatment as usual. PoMeT was delivered in up to 12 individual sessions within 3 months. We stratified randomisation by site and by severity of depression using randomised-permuted blocks. Assessments were carried out at baseline, 3-month, 6-month and 9-month by assessors who were blind to treatment allocation. The primary outcome was reduction in the symptoms of depression at 3-month, 6-month and 9-month as measured by the BDI-II. Analysis was by intention-to-treat with linear mixed-effects models. The trial was registered with the ISRCTN registry number 99485756. RESULTS:One hundred participants were randomly assigned to either PoMeT (n = 49) or treatment as usual (n = 51). The reduction in BDI-II total score at 3 months was significantly greater for PoMeT than for treatment as usual (mean difference = 4.33, SE = 2.00, 95% CI 0.38 to 8.23; p = 0.03). DISCUSSION: To our knowledge this is, to date, the largest powered randomised controlled trial focused on the psychological treatment of depression in people diagnosed with schizophrenia. Results indicate that a brief targeted intervention can reduce the symptoms of depression in the group. The main limitation of the study is the lack of an active control group which may contribute to an inflated treatment effect.
RCT Entities:
BACKGROUND: Around half of people diagnosed with schizophrenia suffer from co-morbid depression, yet there are no evidence-based psychological treatments to target this presentation. METHOD:Participants were aged 18-65 years old, had a clinical diagnosis of schizophrenia or schizoaffective disorder and at least a mild level of depression. Participants were randomly assigned (1:1) to receive PoMeT or treatment as usual. PoMeT was delivered in up to 12 individual sessions within 3 months. We stratified randomisation by site and by severity of depression using randomised-permuted blocks. Assessments were carried out at baseline, 3-month, 6-month and 9-month by assessors who were blind to treatment allocation. The primary outcome was reduction in the symptoms of depression at 3-month, 6-month and 9-month as measured by the BDI-II. Analysis was by intention-to-treat with linear mixed-effects models. The trial was registered with the ISRCTN registry number 99485756. RESULTS: One hundred participants were randomly assigned to either PoMeT (n = 49) or treatment as usual (n = 51). The reduction in BDI-II total score at 3 months was significantly greater for PoMeT than for treatment as usual (mean difference = 4.33, SE = 2.00, 95% CI 0.38 to 8.23; p = 0.03). DISCUSSION: To our knowledge this is, to date, the largest powered randomised controlled trial focused on the psychological treatment of depression in people diagnosed with schizophrenia. Results indicate that a brief targeted intervention can reduce the symptoms of depression in the group. The main limitation of the study is the lack of an active control group which may contribute to an inflated treatment effect.
Authors: Judit Simon; Noemi Kiss; Kees Korrelboom; David Kingdon; Til Wykes; Peter Phiri; Mark van der Gaag; M Fazil Baksh; Craig Steel Journal: Int J Environ Res Public Health Date: 2022-09-22 Impact factor: 4.614