Re-evaluating randomized clinical trials of psychological interventions: Impact of response shift on the interpretation of trial results
| Autor: | Mirjam A. G. Sprangers, W. van Ballegooijen, M. de Wit, Mathilde G. E. Verdam, C. J. M. Holtmaat, I.M. Verdonck de Leeuw, Heleen Riper, Jaap Lancee, Frans J. Oort, T. van der Zweerde, A. van Straten, Hans Knoop |
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| Přispěvatelé: | Psychiatry, APH - Mental Health, Otolaryngology / Head & Neck Surgery, Medical psychology, Gastroenterology and hepatology, APH - Global Health, APH - Personalized Medicine, CCA - Cancer Treatment and quality of life, Amsterdam Reproduction & Development (AR&D), Clinical Psychology, Developmental Psychopathology (RICDE, FMG), Klinische Psychologie (Psychologie, FMG), Methods and Statistics (RICDE, FMG), Medical Psychology, CCA - Cancer Treatment and Quality of Life, APH - Aging & Later Life, APH - Methodology, Montazeri Ali |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Male
Physiology medicine.medical_treatment Cancer Treatment Psychological intervention Social Sciences law.invention Group psychotherapy Medical Conditions Endocrinology Randomized controlled trial law Sleep Initiation and Maintenance Disorders Medicine and Health Sciences Psychology Randomized Controlled Trials as Topic education.field_of_study Multidisciplinary Depression Cognition Middle Aged Clinical Psychology Mental Health Neurology Oncology Medicine Female Research Article Clinical psychology Insomnia Endocrine Disorders Science Population Context (language use) Structural equation modeling SDG 3 - Good Health and Well-being Intervention (counseling) Mental Health and Psychiatry Diabetes Mellitus medicine Humans education Cognitive Behavioral Therapy Mood Disorders business.industry Cognitive Psychology Biology and Life Sciences Cancers and Neoplasms Dyssomnias Psychotherapy Metabolic Disorders Cognitive Science Sleep Disorders Physiological Processes Sleep business Mental Health Therapies Neuroscience |
| Zdroj: | PLoS ONE, Vol 16, Iss 5, p e0252035 (2021) PLoS ONE, 16(5):e0252035. Public Library of Science Verdam, M G E, van Ballegooijen, W, Holtmaat, C J M, Knoop, H, Lancee, J, Oort, F J, Riper, H, van Straten, A, Verdonck-de Leeuw, I M, de Wit, M, van der Zweerde, T & Sprangers, M A G 2021, ' Re-evaluating randomized clinical trials of psychological interventions : Impact of response shift on the interpretation of trial results ', PLoS ONE, vol. 16, no. 5, e0252035 . https://doi.org/10.1371/journal.pone.0252035, https://doi.org/10.1371/journal.pone.0252035 Verdam, M G E, Van Ballegooijen, W, Holtmaat, C J M, Knoop, H, Lancee, J, Oort, F J, Riper, H, Van Straten, A, Leeuw, IMV-D, Wit, M D, Van Der Zweerde, T & Sprangers, M A G 2021, ' Re-evaluating randomized clinical trials of psychological interventions : Impact of response shift on the interpretation of trial results ', PLoS ONE, vol. 16, no. 5 May, e0252035 . https://doi.org/10.1371/journal.pone.0252035 PLoS ONE, 16(5 May):e0252035. Public Library of Science PLoS ONE, 16(5). Public Library of Science (PLoS) PLoS ONE |
| ISSN: | 1932-6203 |
| DOI: | 10.1371/journal.pone.0252035 |
| Popis: | Background Effectiveness of psychological treatment is often assessed using patient-reported health evaluations. However, comparison of such scores over time can be hampered due to a change in the meaning of self-evaluations, called ‘response shift’. Insight into the occurrence of response shift seems especially relevant in the context of psychological interventions, as they often purposefully intend to change patients’ frames of reference. Aims The overall aim is to gain insight into the general relevance of response shift for psychological health intervention research. Specifically, the aim is to re-analyse data of published randomized controlled trials (RCTs) investigating the effectiveness of psychological interventions targeting different health aspects, to assess (1) the occurrence of response shift, (2) the impact of response shift on interpretation of treatment effectiveness, and (3) the predictive role of clinical and background variables for detected response shift. Method We re-analysed data from RCTs on guided internet delivered cognitive behavioural treatment (CBT) for insomnia in the general population with and without elevated depressive symptoms, an RCT on meaning-centred group psychotherapy targeting personal meaning for cancer survivors, and an RCT on internet-based CBT treatment for persons with diabetes with elevated depressive symptoms. Structural equation modelling was used to test the three objectives. Results We found indications of response shift in the intervention groups of all analysed datasets. However, results were mixed, as response shift was also indicated in some of the control groups, albeit to a lesser extent or in opposite direction. Overall, the detected response shifts only marginally impacted trial results. Relations with selected clinical and background variables helped the interpretation of detected effects and their possible mechanisms. Conclusion This study showed that response shift effects can occur as a result of psychological health interventions. Response shift did not influence the overall interpretation of trial results, but provide insight into differential treatment effectiveness for specific symptoms and/or domains that can be clinically meaningful. |
| Databáze: | OpenAIRE |
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