Chen 2011a.

Study characteristics
Methods	Study design Parallel RCT Study dates Duration of follow‐up: 6 weeks Time frame: July to October 2009. The trial was initiated on November 2009 and ended on December 2009
Participants	Study characteristics Setting: single centre (Far Eastern Memorial Hospital) Country: Taiwan Inclusion criteria: patients had been receiving maintenance HD for > 6 months; subjects who had a PSQI score of > 5 during enrolment screening; ≥ 18 years; a history of sleep disturbance for > 6 months Exclusion criteria: subjects with active medical psychiatric conditions and other documented symptoms of OSA (defined as Epworth Sleepiness Scale > 10 or typical symptoms) and periodic limb movement disorders, such as restless legs syndrome Baseline characteristics Number (analysed/randomised): intervention group (37/40); control group (35/40) Mean age ± SD (years): intervention group (57 ± 9); control group (59 ± 11) Sex (M/F): intervention group (17/20); control group (13/22) Dialysis type: HD Mean dialysis vintage ± SD (years): intervention group (5.8 ± 4.0); control group (6.0 ± 5.0) Comorbidities CVD: not reported Diabetes: intervention group (12/37); control group (12/35) Hypertension: intervention group (22/37); control group (22/35) Depression (clinician diagnosis): not reported
Interventions	Intervention classification Non‐pharmacological intervention Indication: study targeting fatigue Intervention group CBT: 3 times/week Control group Sleep hygiene education Co‐interventions The study patients received 3.5 to 5 hours of HD 3 times/week with a blood flow rate of 250 to 300 mL/min and dialysate flow of 500 to 800 mL/min, using bicarbonate dialysate and reverse osmosis‐purified water All of the participants used high‐flux polysulfone membrane as the dialyser All participants received sleep hygiene education
Outcomes	Outcomes reported Fatigue outcome measures used: validation data available Sleep PSQI: assessed at baseline and at 6 weeks Sleep quality Sleep latency Sleep duration Sleep efficiency Sleep disturbances Use of sleep medication Daytime dysfunction Fatigue FSS: assessed at baseline and at 6 weeks Sleep efficiency Sleep disturbances Use of sleep medication Daytime dysfunction Depression BDI: assessed at baseline and at 6 weeks Depression Cognitions Physical symptoms Anxiety BAI: assessed at baseline and at 6 weeks Changes in inflammation and oxidative stress (high‐sensitive CRP, IL‐1beta, IL‐18, oxidized low‐density lipoprotein levels): assessed at baseline and at 6 weeks Kt/V: assessed at baseline and at 6 weeks
Notes	Additional information Funding: grants from the Far Eastern Memorial Hospital (FEMH‐97‐D‐039) in Taiwan, Ta‐Tung Kidney Foundation and to Hsin‐Chin Lee Kidney Research Fund Conflicts of interest/disclosures: none Trial registration identification number: not reported A priori published protocol: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "We randomised participants by computer‐generated random numbers with an allocation ratio of 1:1; that is, either to the CBT group or to the control group." Comment: Computer‐generated randomised numbers is considered as low risk of bias. No imbalance between intervention groups was apparent
Allocation concealment (selection bias)	Unclear risk	Quote: "The generation of allocation sequence and assignment of participants was performed by the project director." Comment: It was not stated if the enrolling investigator (project director) had knowledge of the forthcoming allocation. No imbalance between intervention groups was apparent
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "This study was an open‐labelled design. Participants were informed of their allocation sequence by the nursing staff, and the sequence was concealed until the interventions were assigned." Comment: An open‐blinded study is considered as high risk of bias
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "Fatigue was assessed using a questionnaire. The four measurements were completed before and after the 6‐week trial by all of the participants in both groups." Comment: The outcomes were assessed with an appropriate measure, without differences between groups. However, subjective measures were used, it was not stated whether outcomes were assessed without knowledge of treatment allocation, and knowledge of treatment assignment may have influenced reporting. Participant beliefs about the superiority/inferiority of either intervention could have influenced their assessment of the outcome, but there was no evidence that this was likely. However, objective and subjective outcomes were assessed
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "After randomisation, three participants in the CBT group and five participants in the control group refused to participate and withdrew their informed consent because of personal considerations. Therefore, a total of 72 subjects (37 in the CBT group and 35 in the control group) participated." Comment: 37/40 participants in the intervention group and 35/40 participants in the control group completed the study (> 5% lost to follow‐up, with differences between groups). Reasons for discontinuations seemed to be not related to the treatment allocation
Selective reporting (reporting bias)	High risk	Information about the protocol and the statistical analysis plan were not reported. Fatigue was reported using multiple eligible outcome measurements (scales, time points). Fatigue was reported in a format that was extractable for meta‐analysis. All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were not reported
Other bias	Low risk	There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding was unlikely to influence the data analysis and authors had no conflicts of interest. The study seemed to be free from other source of bias