Chen 2008a.

Study characteristics
Methods	Study design Parallel RCT Study dates Duration of follow‐up: 4 weeks Time frame: participants were recruited from July to August 2005. The trial was initiated on September 2005 and ended on October 2005
Participants	Study characteristics Setting: single centre (the National Taiwan University Hospital) Country: Taiwan Inclusion criteria: undergoing PD > 3 months; ≥ 18 years; history of sleep disturbance > 3 months Exclusion criteria: active medical or unstable psychiatric condition and other documented symptoms of obstructive sleep apnoea and periodic limb movement disorders, such as restless legs syndrome Baseline characteristics Number (analysed/randomised): intervention group (13/13); control group (13/13: 11/13 participants completed the study, but outcomes data were provided for all participants) Mean age ± SD (years): intervention group (51.9 ± 8.6); control group (48.7 ± 14.6) Sex (M/F): intervention group (8/5); control group (7/6) Dialysis type: PD Mean dialysis vintage ± SD (years): intervention group (3.1 ± 2.2); control group (3.7 ± 2.7) Comorbidities CVD: not reported Diabetes: intervention group (4/13); control group (1/13) Hypertension: not reported Depression (clinician diagnosis): not reported
Interventions	Intervention classification Non‐pharmacological intervention Indication: study targeting fatigue Intervention group CBT Control group Sleep hygiene education Co‐interventions All received conventional glucose‐based lactate buffer PD solutions All participants received sleep hygiene education before the 4‐week trial
Outcomes	Outcomes reported Fatigue outcome measures used: validation data available Change in sleep PSQI: total score ranged from 0 to 21 points, with higher scores meaning poorer sleep quality (assessed before and after therapy) Sleep quality Sleep latency Sleep duration Sleep efficiency Sleep disturbances Use of sleep medication Daytime dysfunction Change in fatigue FSS: assessed before and after therapy (Appendix 3) Blood samples (Hb, albumin, calcium, phosphorus, BUN, creatinine, intact PTH): assessed before and after therapy Normalized protein catabolic rate: assessed before and after therapy Calcium‐phosphate product: assessed before and after therapy Kt/V: assessed before and after therapy Residual renal function: assessed before and after therapy Changes in serum IL‐6, IL‐1beta, IL‐18, and TNF‐alfa levels: assessed before and after therapy Adverse events: assessed until the end of treatment
Notes	Additional information Funding: Ta‐Tung Kidney Foundation and the Mrs Hsin‐Chin Lee Kidney Research Fund Conflicts of interest/disclosures: none Trial registration identification number: NCT00155441 A priori published protocol was reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "We randomly assigned participants by using computer generated randomised numbers with an allocation ratio of 1:1; to either the CBT group (13) or the control group (13). No stratification or blocking factors were used." 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 sequence was concealed until the interventions were assigned. [...] 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 pilot study did not use a double‐blind design, and participants were informed of their allocation sequence by telephone." Comment: An open‐label study is considered as high risk of bias. Interventions were different and participants and/or investigators were aware of the treatment assigned
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "Fatigue was assessed using a questionnaire. The 2 measurements were completed before and after the 4‐week trial by all 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	Unclear risk	Quote:"Two participants in the control group withdrew after randomisation for personal considerations (1 person lived too far from the hospital, and the other needed to work in the night‐time during the trial." Comment: Although 2/13 participants withdrawal from the control group, Figure 1 and Table 4 showed that all patients were included in the analysis
Selective reporting (reporting bias)	High risk	Protocol was provided. 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