Ikai 2013.
Methods | Allocation: randomised. Blinding: single blind (raters blind to group status). Duration: 8‐week intervention with 8‐week follow‐up. Design: parallel. Setting: Department of Neuropsychiatry, Yamanashi Prefectural Kita Hospital, Yamanashi, Japan. | |
Participants | Diagnosis: schizophrenia (F20‐F29 according to the International Classification of Diseases, 10th edition).
History: outpatients receiving the same medication for the previous 8 weeks, registered in the day‐care centre.
N = 49.
Age: > 18 years.
Sex: 32M, 18F.
Inclusion criteria: 18 years or older, receiving the same medication for the previous 8 weeks, and registered in the day‐care centre. Exclusion criteria: incapable of providing consent, current substance or alcohol abuse/dependence. |
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Interventions | 1. Yoga therapy: 8 weeks training from ''one of the investigators who held a master's degree of yoga''. The techniques consisted of the following components: (i) warming‐up and loosening‐up exercises for 7 minutes (including guided meditation for 3 minutes), (ii) yoga postures (asanas) for 28 minutes, (iii) relaxation for 7 minutes, (iv) breathing exercises for 8 minutes (n = 25). 2. Standard care: a weekly regular day‐care programme consisting of social‐skills training and psycho‐education. Both yoga and standard‐care groups were registered in the regular day‐care programme and could avail ''ambulatory treatment'' that consisted of non‐structured clinical management such as pharmacotherapy, and very brief psychotherapy by participant's treating psychiatrist (from personal communication with study author 06.08.15). Medications were kept constant by participants' treating psychiatrists throughout the study period unless a change was clinically indicated. |
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Outcomes | Mental state: PANSS Social functioning: FACT‐Sz Quality of life: EQ‐5D Leaving the study early. Unable to use: Postural sway, flexibility, electrocardiogram, DIEPSS ‐ not listed in protocol |
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Notes | Note: same study location and procedure and a number of common authors as Ikai 2014, but the current study took place between June 2012 and October 2012. 16‐week follow‐up data included for yoga group only. 8‐week data included for standard‐care group; assumed 8‐week data for this group was stable. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: ''the randomization list without any stratification or blocks was made with a use of computer program''. Response: Low risk. |
Allocation concealment (selection bias) | Low risk | Quote: ''opaque envelopes were opened after the baseline assessment'' Response: Likely to be adequate. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and personnel delivering the yoga intervention will be aware they are undertaking or delivering the yoga intervention. Response: Unclear risk. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: ''All assessments were performed by trained psychiatrists who were blind to a subjects' allocation and were not involved in the yoga therapy''. Response: Low risk. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 16‐week follow‐up data included for yoga group only. 8‐week data included for standard‐care group. Response: High risk. |
Selective reporting (reporting bias) | Low risk | All outcomes listed were reported. |
Other bias | Unclear risk | Adherence of groups to day‐care programme and ''ambulatory treatment'' is not specified. |