McLaughlin 2005.
| Methods | RCT design: 2‐arm parallel group trial Total N randomised: 100 Length of follow‐up: 4 months Analysis: Per‐protocol (8 treatment patients dropped out, 12 control patients (1 death) dropped out) |
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| Participants | Location: USA Number of study centres and setting: Patients with Acute Coronary Syndrome (ACS) from 2 Hospitals CAD diagnosis: Acute Coronary Syndrome (ACS) assessed by medical chart review in the coronary care unit; time to randomisation not specified Depression diagnosis: Score of 7 and more on either of the subscales of the Hospital Anxiety Depression Scale (HADS) Other entry criteria: 35 years of age or older, able to speak English, access to a touch‐tone phone Exclusion criteria: Mental health care in the prior 3 months, psychoactive drug use during the past year, and diagnosis of substance abuse during the past year Treatment N: 45 (31.1% female, mean age: 59.9 (SD: 10.2)) Control N: 34 (35.3% female, mean age: 60.7 (SD: 9.8)) Comparability of the groups: Significantly higher anger scores among females in the treatment group, significantly more patients with Myocardial Infarction (MI) in the treatment group |
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| Interventions | Treatment: 6 telephone counselling sessions (30 minutes each) with clinicians (psychiatrist, clinical psychologist, internist) comprising review of common fears experienced by those living with chronic medical conditions and identification and management of barriers to adjustment to medical illness; patients with HADS score > 15 were referred for emergent care Control: Usual care (received a booklet on coping with cardiac illness typical of those given at hospital discharge and were instructed to contact their primary care physician if they experienced any warning signs of depression; advised to continue follow‐up with their primary care and specialist physicians) Duration of treatment: 8 weeks |
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| Outcomes | Review outcomes: HADS depression score Other outcomes: HADS anxiety score, Work and Social Adjustment Scale (WSAS), State‐Trait Anger Expression Inventory (STAXI), Clinical Global Impressions (CGI) scale |
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| Funding | National Institute of Mental Health, USA; Robert Wood Johnson Foundation | |
| Notes | Mixed study sample (patients with depression and/or anxiety) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "by coin flip" (p. 1085 in McLaughlin et al., 2005) |
| Allocation concealment (selection bias) | High risk | Quote: "The study coordinator conducted the coin flip and assigned patients to a treatment arm when she contacted study participants by telephone and enrolled consenting participants." (p. 540 in Bambauer et al., 2005) |
| Blinding (performance bias and detection bias) All outcomes | High risk | Comment: Patient self‐report (HADS) |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: The authors describe that multiple imputation methods were used to examine if data were missing at random. But all analyses were reported for the final cohort of 79 patients |
| Selective reporting (reporting bias) | Unclear risk | Comment: Outcomes consistent in methods and results sections Comment: No protocol and design paper available |
| Other bias | High risk | Comment: Results reported inconsistently (discrepancy between text and figure regarding HADS score) |