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. 2019 Dec 2;2019(12):CD004542. doi: 10.1002/14651858.CD004542.pub3

Vogt 2016.

Methods
  • Study design: parallel RCT

  • Time frame: not reported

  • Follow‐up period: 4 months follow‐up (6 weeks of intervention)

Participants
  • Country: The UK

  • Setting: multicentre; four dialysis clinics in the UK

  • Inclusion criteria: consenting ESKD patients who met the cut‐off for depression and other eligibility criteria (not reported)

  • Number (analysed/randomised): treatment group (not reported/4); control group (not reported/5)

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Antidepressant medication: not reported

  • Exclusion criteria: not reported

Interventions Treatment group
  • Acceptance and Commitment Therapy (telephone‐supported self‐help based on ACT) + usual care


Control group
  • Usual care


Co‐interventions
  • Not reported

Outcomes
  • HRQoL

    • EuroQol (EQ‐5D‐5L)

  • Depression

    • Patient Health Questionnaire (PHQ‐9): cutoff at least 10 = depression

  • Acceptance and Action Questionnaire II

  • Valued Living Questionnaire (VLQ)

Notes
  • Abstract‐only publication

  • Funding source: not reported

  • Trial registration identification number: not reported

  • Corresponding author: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Sequence generation methods were not reported in sufficient detail to perform an adjudication
Allocation concealment (selection bias) Unclear risk Method of allocation concealment was not reported in sufficient detail to perform an adjudication
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Blinding of participants and/or the investigators was not reported. The methods of intervention and control treatment were physically different. Participants and investigators could be aware on the treatment allocation group
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported in sufficient detail to perform an adjudication
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Not reported in sufficient detail to perform an adjudication
Selective reporting (reporting bias) Unclear risk Not reported in sufficient detail to perform an adjudication
Other bias Unclear risk Not reported in sufficient detail to perform an adjudication

AIS ‐ Acceptance of Illness Scale; BDI ‐ Beck Depression Index; BP ‐ blood pressure; CBT ‐ cognitive‐behavioural therapy; CES‐D ‐ Center for Epidemiological Studies Depression; CKD ‐ chronic kidney disease; DASS ‐ Depression Anxiety Stress Scales; DBP ‐ diastolic blood pressure; DSM ‐ Diagnostic and Statistical Manual of Mental Disorders; ESKD ‐ end‐stage kidney disease; HCT ‐ hematocrit; HD ‐ haemodialysis; HADS ‐ Hospital Anxiety Depression Scale; HAM‐D ‐ Hamilton Depression Rating Scale; HRQoL ‐health‐related quality of life; IDWG ‐ interdialytic weight gain; KDQOL‐SF ‐ Kidney Disease and Quality of Life‐Short Form; Kt/V ‐ dialyser urea clearance adequacy; M/F ‐ male/female; MHS ‐ Miller Hope Scale; MINI ‐ Mini International Neuropsychiatric Interview; NYHA ‐ New York Heart Association; QoL ‐ quality of life; RCT ‐ randomised controlled trial; SBP ‐ systolic blood pressure; SCID ‐ structured clinical interview for DSM; SD ‐ standard deviation; STAI ‐ State‐Trait Anxiety Inventory; SCr ‐ serum creatinine; URR ‐ urea reduction ratio