van der Borg 2016.

Study name	Protocol of a mixed method, randomized controlled study to assess the efficacy of a psychosocial intervention to reduce fatigue in patients with End‐Stage Renal Disease (ESRD)
Methods	Study design RCT Duration of follow‐up: 9 months
Participants	Study characteristics Country: the Netherlands Setting: not reported Inclusion criteria Dialysis patients (either HD or PD at home, a hospital or a dialysis centre) ≥ 18 years Male or female experiencing (severe) fatigue (score CIS scale ≥ 35) Being able to walk/move for at least 10 min with or without a supporting device such as a walking stick; having a sufficient understanding of the Dutch language in order to participate in counselling (group) interviews and fill out the questionnaires adequately Exclusion criteria Dialysis during the night (since it is assumed that patients on day dialysis experience more severe fatigue compared to patients on night dialysis) Participation in other studies or treatments aimed at reducing fatigue Treatment by a psychologist or psychiatrist (for severe psychiatric problems such as depression, psychosis, personality disorders or schizophrenia) Alcohol or drug addiction
Interventions	Intervention group Psychosocial counselling sessions led by a social worker (8 modules) + usual treatment Control group Usual care Co‐interventions Not reported
Outcomes	Planned outcomes Fatigue severity CIS‐fatigue questionnaire: assessed at baseline, post‐intervention/16 weeks, and at 3 and 6‐month follow‐up Quality of life (kidney disease specific) KDQOL: assessed at baseline, post‐intervention/16 weeks, and at 3 and 6‐month follow‐up Coping style Illness cognitions/perceptions Catastrophizing thoughts Depression Social support Overall perceptions Implementation process Interviews and focus groups (qualitative approach): assessed at baseline, post‐intervention/16 weeks, and at 3 and 6‐month follow‐up Patients’ and social workers’ expectations and experiences Interviews and focus groups (qualitative approach): assessed post‐intervention Medical parameters: assessed at baseline, post‐intervention/16 weeks, and at 3 and 6‐month follow‐up Adverse events: assessed post‐intervention
Starting date	Not reported. Trial was registered on August 2015
Contact information	Wieke E. van der Borg Phone: not reported Email: not reported
Notes	The Netherlands National Trial Register (NTR): NTR5366. Funding: Dutch Kidney Foundation. Recruitment status: not reported