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. 2023 Jan 3;2023(1):CD011881. doi: 10.1002/14651858.CD011881.pub2

Li 2009.

Study characteristics
Methods Study design: RCT
Follow‐up: week 15
Participants Country: China, Yangpu District of Shanghai City
Setting: 1 mental health centre
Inclusion criteria:
  • participants qualified under the Chinese Classification of Mental Disorders Version 3 diagnosis Standard

  • PSQI total score > 7


Exclusion criteria:
  • people with other major systematic disorders/dysfunctions (heart, liver, kidney, etc.)

  • other mental disorders

  • people with low compliance.


Baseline characteristics: not reported
Number of participants completing the study: 68 (IG 34, CG 34)
Group differences: no differences between IG and CG in age, year, sex, disease course, education level, and PSQI score (P > 0.05).
Interventions Intervention: 12 weeks of 1. morning exercise from 8.00 a.m. to 9.00 a.m. outdoor activities for 60 minutes, 2. afternoon activities according to participants' interest, such as painting, games, and music; 3. no napping: participants were allowed to go to bed only when sleepy without reading or television in bed as well as limited food intake 15–30 minutes before going to bed, and 4. getting up at 6.30 a.m. every morning.
Control: usual care
Co‐intervention: before study start, both groups received oral estazolam 1 mg (no further information available)
Outcomes
  • Sleep quality (PSQI)

Funding Sponsorship source: unclear
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Sequence generation Unclear risk Study mentioned "randomization", but no details given on the method.
Allocation concealment Unclear risk Study mentioned "randomization", but no details given on the method.
Blinding of participants and personnel
All outcomes Unclear risk Unknown.
Blinding of participants and personnel
Subjective sleep quality (carer ratings) Unclear risk Unknown.
Blinding of participants and personnel
Objective sleep measures Unclear risk Unknown.
Blinding of outcome assessors
Objective outcome measures Unclear risk No information given.
Blinding of outcome assessors
Subjective sleep quality (carer ratings) Unclear risk No information available.
Incomplete outcome data
All outcomes Low risk Data for all outcomes provided.
Selective outcome reporting Unclear risk No study protocol available and the study was not registered.
Other sources of bias Low risk None.