Hou 2014.
Methods |
Study design: randomised controlled trial Study grouping: parallel group |
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Participants |
Inclusion criteria:
Exclusion criteria:
Characteristics of carers of people with dementia
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Interventions |
MBSR
Self help control
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Outcomes |
Carers' depressive symptoms
Carers' anxiety
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Identification |
Sponsorship source: research grant from the Food and Health Bureau Country: Hong Kong, China |
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Notes | Adherence to intervention: "83% participants attended at least 6 sessions in MBSR and 43% attended all 8 sessions" Adverse events: "Only 1 male aged 80 strained his neck when practicing yoga at home, which did not inhibit him from participating in the weekly MBSR course." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk |
Quote: "Randomization was conducted independently by a research assistant using the random numbers generated in Microsoft Excel 2003 and was not disclosed until the eligible participants completed baseline assessment and signed the informed consent form." Comment: Adequate sequence generation |
Allocation concealment (selection bias) | Low risk |
Quote: "the random numbers generated in Microsoft Excel 2002 and was not disclosed until the eligible participants completed baseline assessment and signed the informed consent form Comment: Adequate allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk |
Quote: "The intervention group received MBSR, while the control group received self‐help health education booklets"; "The first and most important limitation is that we did not employ an active control group. The effects of MBSR can be overestimated because of the potential beneficial effects of social interaction and extra attention given to them by the intervention." Comment: Inactive control used in this study, plus the challenge of blinding participants or personnel or both for psychosocial interventions of this nature |
Blinding of outcome assessment (detection bias) All outcomes | High risk |
Quote: "participants were asked to self‐administer the questionnaires." Comment: Results from self reported scales may lead to a risk of detection bias. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk |
Quote: "The total attrition rate of this study was 19.9%; the MBSR group had a significantly lower attrition rate than the control group (12.9% vs. 26.8%; P < 0.05)." "The attritions were significantly younger (P < 0.05) and had a lower level of physical activity (P < 0.05)." Comment: The study used intention‐to‐treat analyses, however the imputation method for missing data was not described. |
Selective reporting (reporting bias) | Unclear risk |
Comment: We did not find a published protocol. |
Other risks of bias | Low risk | Not identified |