Only one cluster per condition is an invalid design for a cluster randomized trial and should be re-labeled a quasi-experimental study. Response to: “Effect of behavioral activation on time and frequency domain heart rate variability in older adults with subthreshold depression: a cluster randomized controlled trial in Thailand”

Abstract Ayudhaya et al. examined the effect of Behavioral Activation on daily step count and heart rate variability among older adults with depression in a study labeled a cluster randomized controlled trial (cRCT). However, only one cluster was assigned to either of the study conditions. Such a de...

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Main Authors: Yasaman Jamshidi-Naeini, Lilian Golzarri-Arroyo, Abu Bakkar Siddique, Colby J. Vorland, David B. Allison
Format: Article
Language:English
Published: BMC 2023-01-01
Series:BMC Psychiatry
Subjects:
Online Access:https://doi.org/10.1186/s12888-022-04491-0
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author Yasaman Jamshidi-Naeini
Lilian Golzarri-Arroyo
Abu Bakkar Siddique
Colby J. Vorland
David B. Allison
author_facet Yasaman Jamshidi-Naeini
Lilian Golzarri-Arroyo
Abu Bakkar Siddique
Colby J. Vorland
David B. Allison
author_sort Yasaman Jamshidi-Naeini
collection DOAJ
description Abstract Ayudhaya et al. examined the effect of Behavioral Activation on daily step count and heart rate variability among older adults with depression in a study labeled a cluster randomized controlled trial (cRCT). However, only one cluster was assigned to either of the study conditions. Such a design would have zero degrees of freedom for inferential testing, because the variation due to cluster membership cannot be estimated apart from the variation due to treatment assignment. Thus, the intervention effect is completely confounded with the cluster effect. The study should be labeled a quasi-experimental study, not a cRCT. Accordingly, the numerical results should be interpreted as associations but not evidence for causal relationships.
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spelling doaj.art-89d731053c1b4d7582de88649f804ecc2023-01-15T12:17:55ZengBMCBMC Psychiatry1471-244X2023-01-012311210.1186/s12888-022-04491-0Only one cluster per condition is an invalid design for a cluster randomized trial and should be re-labeled a quasi-experimental study. Response to: “Effect of behavioral activation on time and frequency domain heart rate variability in older adults with subthreshold depression: a cluster randomized controlled trial in Thailand”Yasaman Jamshidi-Naeini0Lilian Golzarri-Arroyo1Abu Bakkar Siddique2Colby J. Vorland3David B. Allison4Department of Epidemiology and Biostatistics, Indiana University School of Public Health- BloomingtonDepartment of Epidemiology and Biostatistics, Indiana University School of Public Health- BloomingtonDepartment of Epidemiology and Biostatistics, Indiana University School of Public Health- BloomingtonDepartment of Epidemiology and Biostatistics, Indiana University School of Public Health- BloomingtonDepartment of Epidemiology and Biostatistics, Indiana University School of Public Health- BloomingtonAbstract Ayudhaya et al. examined the effect of Behavioral Activation on daily step count and heart rate variability among older adults with depression in a study labeled a cluster randomized controlled trial (cRCT). However, only one cluster was assigned to either of the study conditions. Such a design would have zero degrees of freedom for inferential testing, because the variation due to cluster membership cannot be estimated apart from the variation due to treatment assignment. Thus, the intervention effect is completely confounded with the cluster effect. The study should be labeled a quasi-experimental study, not a cRCT. Accordingly, the numerical results should be interpreted as associations but not evidence for causal relationships.https://doi.org/10.1186/s12888-022-04491-0Cluster randomized trialDegrees of freedomInferential testingNesting
spellingShingle Yasaman Jamshidi-Naeini
Lilian Golzarri-Arroyo
Abu Bakkar Siddique
Colby J. Vorland
David B. Allison
Only one cluster per condition is an invalid design for a cluster randomized trial and should be re-labeled a quasi-experimental study. Response to: “Effect of behavioral activation on time and frequency domain heart rate variability in older adults with subthreshold depression: a cluster randomized controlled trial in Thailand”
BMC Psychiatry
Cluster randomized trial
Degrees of freedom
Inferential testing
Nesting
title Only one cluster per condition is an invalid design for a cluster randomized trial and should be re-labeled a quasi-experimental study. Response to: “Effect of behavioral activation on time and frequency domain heart rate variability in older adults with subthreshold depression: a cluster randomized controlled trial in Thailand”
title_full Only one cluster per condition is an invalid design for a cluster randomized trial and should be re-labeled a quasi-experimental study. Response to: “Effect of behavioral activation on time and frequency domain heart rate variability in older adults with subthreshold depression: a cluster randomized controlled trial in Thailand”
title_fullStr Only one cluster per condition is an invalid design for a cluster randomized trial and should be re-labeled a quasi-experimental study. Response to: “Effect of behavioral activation on time and frequency domain heart rate variability in older adults with subthreshold depression: a cluster randomized controlled trial in Thailand”
title_full_unstemmed Only one cluster per condition is an invalid design for a cluster randomized trial and should be re-labeled a quasi-experimental study. Response to: “Effect of behavioral activation on time and frequency domain heart rate variability in older adults with subthreshold depression: a cluster randomized controlled trial in Thailand”
title_short Only one cluster per condition is an invalid design for a cluster randomized trial and should be re-labeled a quasi-experimental study. Response to: “Effect of behavioral activation on time and frequency domain heart rate variability in older adults with subthreshold depression: a cluster randomized controlled trial in Thailand”
title_sort only one cluster per condition is an invalid design for a cluster randomized trial and should be re labeled a quasi experimental study response to effect of behavioral activation on time and frequency domain heart rate variability in older adults with subthreshold depression a cluster randomized controlled trial in thailand
topic Cluster randomized trial
Degrees of freedom
Inferential testing
Nesting
url https://doi.org/10.1186/s12888-022-04491-0
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