Zarea 2014.
| Study characteristics | ||
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 74 Length of follow‐up: 2 and 4 months' post‐treatment Analysis: per‐protocol (method of analysis not stated, also no information on participant flow chart) |
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| Participants | Location: Iran Number of study centres and setting: Al‐Zahra Heart Hospital CAD criteria: all patients who were candidates for coronary artery bypass referred to the research environment on a non‐emergency basis (being in a bypass list) Depression criteria: moderate to severe depression and anxiety scores (HADS) Other entry criteria: no history of mental illness, interested in participating in the study (i.e. the tendency of the patient and their family to participate in the intervention), lack of previous bypass surgery, aged between 35 and 70 years, ability to communicate verbally and ability to speak Persian Exclusion criteria: lack of co‐operation of patients and families during the intervention, failure to perform coronary artery bypass surgery for various reasons, mortality during the study, failure to attend therapeutic communication sessions (absence of 2 or more sessions) Treatment N: 37 (29.7% female, 100% aged 51 to 70 years) Control N: 37 (51.4% female, 100% aged 51 to 70 years) Comparability of groups: not stated. Different gender distribution |
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| Interventions | Treatment: therapeutic communication sessions were held for the intervention group based on Peplau's model at 4 stages, including orientation, identification, exploitation, and resolution. In total, 7 sessions were held individually with the consent of the participant and their family at the hospital and the participant's home. It should be noted that during therapeutic communication, duration of each session varied given the location and participant's needs. Control: not stated Duration of treatment: not stated. Quote: "...duration of each session was variable..." (p 161), total treatment duration unclear |
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| Outcomes | Review outcomes: depression symptoms (HADS Depression) Other outcomes: anxiety symptoms (HADS Anxiety) |
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| Funding | None | |
| Notes | Mixed study sample (patients with depression and/or anxiety were enrolled) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Comment: The subjects were randomly divided into test and control groups using a coin toss |
| Allocation concealment (selection bias) | Unclear risk | Comment: No information on allocation concealment |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: Participants and therapists unblinded Comment: Unclear the number and type of staffs involved in the study |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: The procedures for obtaining outcome data are unclear |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: No information on participant flow or attrition |
| Selective reporting (reporting bias) | Unclear risk | Comment: Trial registry congruent with reported outcomes for depression and anxiety (HADS) Comment: Depression and anxiety (HADS) data reported as unadjusted means and analysis of covariance across all timepoints |
| Other bias | Unclear risk | Comment: No indication of intervention fidelity and monitoring |
ACE: angiotensin‐converting enzyme ACS: acute coronary syndrome BDI: Beck Depression Inventory BMI: body mass index BP: blood pressure CABG: coronary artery bypass graft CAD: coronary artery disease CBT: cognitive‐behavioural therapy CCS: Canadian Cardiovascular Society Angina Class CHD: coronary heart disease CK‐MB: creatine kinase myocardial band CM: clinical management DISH: Depression Interview and Structured Hamilton ECG: electrocardiogram HADS: Hospital Depression and Anxiety Scale HAM‐D: Hamilton Rating Scale for Depression HR: heart rate IPT: interpersonal psychotherapy ITT: intention‐to‐treat LDL: low‐density lipoprotein LVEF: left ventricular ejection fraction MI: myocardial infarction NYHA: New York Heart Association PCI: percutaneous coronary intervention PHQ‐9: Patient Health Questionnaire PTCA: percutaneous transluminal coronary angioplasty RCT: randomised controlled trial SADS: Schedule of Affective Disorders and Schizophrenia SCID: Structured Clinical Interview for Depression SCL 90‐R: Symptom Checklist 90‐Revised SD: standard deviation SSM: supportive stress management SSRI: selective serotonin reuptake inhibitor STAI: State‐Trait Anxiety Inventory TCM: Traditional Chinese Medicine WBT: well‐being therapy