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. 2019 Mar 14;2019(3):CD010748. doi: 10.1002/14651858.CD010748.pub2

Fielding 1980.

Methods Study design: parallel RCT
Recruitment: participants were recruited at discharge from the CCU
Allocation: not reported
Blinding: not blinded
Randomisation: not reported
Follow‐up(s): 6 months
Description: weekly group meetings with a psychologist with relaxation training
Participants Baseline characteristics
Intervention group "Heart Club"
  • Number of participants randomised: 5

  • Working before CHD: 5

  • Age: < 60 years

  • Sex (male %): 100


Control group
  • Number of participants randomised: 5

  • Working before CHD: 5

  • Age: < 60 years

  • Sex (male %): 100


Inclusion criteria
  • MI patients (according to ECG and enzyme criteria (not further specified))

  • Male

  • < 60 years of age


Exclusion criteria
  • Previous history of heart disease or any other major physical illness

  • Psychiatric complaint in the 2 years prior to present hospitalisation


Baseline imbalances:
Physically demanding work (i.e. white vs. blue collar): unknown
Severity of CHD: unknown
Interventions Intervention
"Heart Club"
  • Person‐directed psychological intervention comprising:

    • weekly meetings for 10 weeks

      • 1st h: anxieties or problems related to MI discussed

      • 30 min of relaxation training (home practice was encouraged)

  • Duration of intervention: 10 weeks

  • Providers: psychologist, a physician attended the group on one session to answer questions of a medical nature and to discuss the mechanisms of MI


Control group
  • These participants were placed on a waiting list and received no meetings

Outcomes Proportion at work at 6 months–12 months (medium term): 6 months
Mean length of illness (sick leave) in days
Anxiety with the Catell Self‐Analysis Form; 9‐point rating scale
Adverse events (reinfarctions)
Identification Sponsorship source: no information
Country: UK
Setting: single setting, outpatient
Possible conflicts of interest: none reported
Ethics committee approval:
Notes Personal communication: information regarding occupational status of the study participants provided by the study author
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk A randomisation method was not described.
Quote: "Ten patients were assessed and randomly allocated to experimental or control groups."
Allocation concealment (selection bias) Unclear risk None described
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Due to the nature of the study, blinding of participants was not possible. Control participants were placed on a ‘waiting list’, which might have influenced their decisions of when to return to work
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk There is no mention of blinding and information regarding the assessment of working status and illness duration is insufficient to determine if these were prone to detection bias.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No dropouts reported; no percentage of 'number working' reported, unclear how many participants remained in each group
Selective reporting (reporting bias) Unclear risk Unable to determine, no study protocol was available
Other bias Unclear risk None identified