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

Leake 1999.

Methods
  • Study design: parallel 3 x 3 factorial design RCT

  • Time frame: not reported

  • Follow‐up period: 1 month

Participants
  • Country: USA

  • Setting: single HD treatment centre (University Hospital at the State University of New York in Stony Brook)

  • Inclusion criteria: in‐centre HD patients who had received HD treatment for at least 5 months

  • Number (analysed/randomised): 41/42

  • CES‐D score at baseline: treatment group (16.7 ± 3.5); control group 1 (16.8 ± 4.1); control group 2 (15.0 ± 3.6)

  • Mean age: 49.5 years

  • Sex (M/F): 26/16

  • Antidepressant medication: not reported

  • Exclusion criteria: not English; patients with cognitive impairment

Interventions Treatment group
  • Strategic self‐presentation: participants presented themselves in a videotaped interview


Control group 1
  • Problem disclosure: participants discussed problems with managing their illness


Control group 2
  • Videotape about adjusting to dialysis


Co‐interventions
  • Developed training materials to help beginning patients adjust to their illness

Outcomes
  • Depression

    • CES‐D: cutoff score of ≥ 16 = depression

      • Physical

      • Psychological

  • Patients' satisfaction

    • Likert‐style scale

  • Patients' perception that questions were representative

    • Likert‐style scale

  • Social desirability and negative affect

    • Marlowe‐Crowne Social Desirability Scale

    • Positive Affect Schedule

    • Negative Affect Schedule

Notes
  • Funding source: not reported

  • There was no reported registration of the trial within a trial registry, as trial registration was not required in 1999

  • Corresponding author: R. Friend (rfriend@psych.1.psy.sunysb.edu)

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Blocks of patients were first categorised by sex, months on dialysis and whether they had a comorbid diagnosis of diabetes; there were then randomly assigned to a condition."
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. 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 Low risk Quote: "Patients completed a questionnaire that served as a baseline measure of adjustment. [...] Four female research assistants, who were unaware of the conditions and hypotheses of the study, conducted the interviews. [...] The first author, who was unaware of the condition to which each patient was assigned, administered the questionnaires at the three time points."
Comment: The first author administered the questionnaires and he was unaware on the treatment assigned group
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "Data for the 1‐month post‐treatment assessment were not available for 1 male patient who ceased treatment before the 1‐month assessment."
Comment: Overall, 1/42 participants was lost to the follow‐up (< 10% loss to follow‐up, it was not clear if there was a substantial 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, death, dialysis withdrawal, adverse events)
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