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

Bahmani 2016.

Methods
  • Study design: parallel RCT

  • Time frame: not reported

  • Follow‐up period: 3 months

Participants
  • Country: Iran

  • Setting: single centre (Shahid Hasheminejad Hospital dialysis section, Iran)

  • Inclusion criteria: female patients with ESKD who were required to refer to the treatment centre 2 to 3 times/week

  • Number (analysed/randomised): treatment group (9/11); control group (11/11)

  • BDI score at baseline: treatment group (16.37 ± 9.37); control group (19.09 ± 9.01)

  • Mean age ± SD (years): not reported

  • Sex (M/F): treatment group (0/11); control group (0/11)

  • Antidepressant medication: not reported

  • Exclusion criteria: not reported

Interventions Treatment group
  • Combination of treatment including some elements of "existentialism" philosophy and a "cognitive" approach, 12 sessions of 90 minutes 2 days/week


Control group
  • No intervention


Co‐interventions
  • Not reported

Outcomes
  • Depression

    • BDI‐II: score lower than 14 defines the minimum level of depression, between 14 to 19 is considered mild, 20 to 28 is moderate, and 29 to 63 is interpreted as a high level of depression

  • Hope

    • MHS

Notes
  • Funding source: not reported

  • Trial registration identification number: not reported

  • Corresponding author: M. M. Najjar (maryam.motamed@gmail.com)

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The patients were randomly assigned into two groups of experimental and control conditions."
Comment: 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. However, the methods of intervention and control treatment were physically different, and therefore masking of intervention was unlikely
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "The tool is used for self‐report of signs of depression for individuals above 13 years old and higher."
Comment: BDI‐II was completed by participants. Participants were likely to be aware of the intervention they received. Therefore, the outcome assessment for depression was not blinded
Incomplete outcome data (attrition bias) 
 All outcomes High risk Quote: "Two of the participants in the experimental group withdrew their participation due to personal problems."
Comment: 2/11 in the intervention group and 0/11 in the control group were lost to the follow‐up for reasons that appeared unrelated to the treatment (> 10% loss to follow‐up; there was a differential loss between groups)
Selective reporting (reporting bias) High risk There was no published protocol for this study. This study did not report many patient‐centred outcomes that might be expected for a study of this type (i.e. life participation, fatigue, dialysis withdrawal, adverse events, death)
Other bias Unclear risk It was not clear if there was evidence of imbalance at baseline. Not reported in sufficient detail to perform an adjudication