Picariello 2018.

Study characteristics
Methods	Study design Parallel RCT Study dates Duration of follow‐up: 3 months Time frame: not reported
Participants	Study characteristics Country: UK Setting: multicentre (two National Health Service sites in England) Inclusion criteria: > 18 years; confirmed ESKD diagnosis; experiencing clinical levels of fatigue defined as scoring > 18 on the CFQ, when using the continuous scoring; full verbal and written proficiency in English; receiving in‐centre HD; length of time on dialysis > 90 days; willing and able to take part in the study and intervention. All participants reported fatigue at baseline Exclusion criteria: no informed consent or refused to be randomised; cognitive impairments, severe mental health disorder (e.g. psychosis and bipolar disorder); do not have full verbal and written proficiency in English; currently receiving psychotherapy; currently participating in any other intervention trial; failing on dialysis; approaching end of life (supportive care/palliative care pathway), have a fatigue (CFQ) score below the cut‐off at the pre‐randomisation assessment (spontaneous improvement after screening) Baseline characteristics Number (analysed/randomised): intervention group (11/12); control group (7/12) Mean age ± SD (years): intervention group (59.8 ± 17.8); control group (53.0 ± 18.0) Sex (M/F): intervention group (8/4); control group (4/8) Dialysis type: HD Dialysis vintage (years): not reported Comorbidities CVD: not reported Diabetes: not reported Hypertension: not reported Depression (clinician diagnosis): not reported
Interventions	Intervention classification Non‐pharmacological intervention Indication: study targeting fatigue Intervention group CBT for fatigue (BReF intervention), 4 to 6 weeks, depending on each participant’s needs Control group Waiting‐list control Co‐interventions Not reported
Outcomes	Outcomes reported Fatigue outcome measures used: validation data available Renal fatigue Fatigue severity CFQ: assessed at baseline and after 3 months Fatigue‐related functional impairment Work and Social Adjustment Scale: assessed at baseline and after 3 months Sleep quality PSQI: assessed at baseline and after 3 months Depression Patient Health Questionnaire‐9: assessed at baseline and after 3 months Anxiety Generalised Anxiety Disorder‐7: assessed at baseline and after 3 months Changes in fatigue perceptions Brief Illness Perception Questionnaire: assessed at baseline and after 3 months Cognitive and behavioural responses to fatigue Cognitive and Behavioural Responses to Symptoms Questionnaire: assessed at baseline and after 3 months Sleep hygiene behaviours Sleep Hygiene Index: assessed at baseline and after 3 months Physical activity International Physical Activity Questionnaire–short form: assessed at baseline and after 3 months
Notes	Additional information Funding: PhD project funded by a Biomedical Research Studentship to Miss Federica Picariello from the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London Conflicts of interest/disclosures: none Trial registration identification number: ISRCTN91238019 A priori published protocol was published Authors contacted and they reported no death
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomisation was stratified by centre and randomly varying block sizes were used to maintain balance of numbers in each arm across the period of recruitment while maintaining allocation concealment. King’s College London’s Independent Randomisation Service was used. Because the randomisation sequence was automated in real time, the allocation sequence was concealed from researchers."
Allocation concealment (selection bias)	Low risk	Quote: "Randomisation was stratified by centre and randomly varying block sizes were used to maintain balance of numbers in each arm across the period of recruitment while maintaining allocation concealment. King’s College London’s Independent Randomisation Service was used. Because the randomisation sequence was automated in real time, the allocation sequence was concealed from researchers."
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "The nature of the trial meant participants were unblinded to their allocations."
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "Follow‐up measures were completed independently by participants via post. An independent researcher, who was not involved in the intervention development or delivery, assisted seven participants with the completion of the follow‐up measures. The statistician (SN) remained blind to treatment allocation until after the analyses were conducted." Comment: Fatigue was 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. It was not stated if the interviewer was blinded to the treatment allocation
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "Eighteen participants completed the follow‐up measures at T1." Comment: 11/12 participants in the intervention group and 7/12 participants in the control group completed the study (> 5% lost to follow‐up, with differences between groups). Reasons for discontinuations were not reported
Selective reporting (reporting bias)	High risk	Information about the protocol were reported. It was not reported if multiple eligible outcome measurements (scales and time points) were pre‐specified. It was unclear if the reported approach to analysing this outcome was pre‐specified or influenced by the results. Fatigue at the end of intervention was reported in a format that was not extractable for meta‐analysis. All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were not reported
Other bias	Low risk	Quote: "The authors alone are responsible for the content and writing of the article." Comment: 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 reporting and authors had no conflicts of interest