| Methods |
In this study the general practitioners (GPs; n = 30) were randomly assigned to either the Depression Care Program (DCP; n = 16), or the Standard Follow‐Up Program (SFP; n = 14). Random treatment assignment was placed in advance in a set of sealed, opaque envelopes by an individual who was not involved in the opening of the envelopes. When a GP was randomized, the GP's name and the number of the envelope were recorded before the envelope was opened. There were a total of 211 patients, 101 from the DCP and 110 from the SFP. The number of patients analyzed were n = 81 in the DCP group and n = 96 for the SFU group |
| Participants |
Patients were eligible for the study if they met the following criteria: primary diagnosis of depression fulfilling the criteria of a major depressive episode according to DSM‐IV; at least 18 years of age; no renal or hepatic dysfunction. Subjects had to give written informed consent prior to participation and the MINI International Neuropsychiatric Interview was used for the diagnostic psychiatric screening. Exclusion criteria were: benzodiazepines not stabilized at a maximum level of 10 mg diazepam or equivalent rate at least 4 weeks prior to start of treatment; use of other psychopharmacological medication; a history of schizophrenia or bipolar disorder; previously unresponsive to selective serotonin reuptake inhibitor (SSRI) therapy (for depression or other indications); women who were pregnant, lactating or not using adequate contraception; a history of seizures (except for febrile seizures in childhood); meeting DSM‐IV criteria for substance abuse within 3 months prior to the start of the trial, respectively substance dependence within 6 months; any serious medical condition that would, in the opinion of the GP, preclude the administration of a SSRI; a current serious suicidal or homicidal risk in the GP's judgment; and current psychological or psychotherapeutic treatment |
| Interventions |
Depression care program: prior to every scheduled visit (7 visits in 26 weeks), the DCP patients received a newsletter by mail, which reviewed the biology and symptoms for depression, as well as the importance of antidepressant medication, and its effects and side effects. In addition, the need to continue treatment for up to 6 months, the value of social support, social stigmas, and common misconceptions about depression were explained. Patients also were asked to complete homework assignments that involved: (1) filling out a questionnaire addressing the perceived costs and benefits of antidepressant medication, (2) planning activities, and (3) discussing their illness and treatment with significant others. Before each visit, the GPs received a summary of the content of the newsletter and the homework assignments and both patients and GPs were encouraged to discuss the topics and homework assignments during the visits. In particular, the GPs clarified the benefits of and perceived costs of taking antidepressant medication
Systematic follow‐up program: patients and GPs in the SFP received no letters, homework, nor instructions. The SFP targeted only the structure of care: follow‐up visits were scheduled and structured, and patients were assessed with the same frequency and with the same instruments as the patients in the DCP group |
| Outcomes |
Adherence with antidepressant medication was assessed during the visits at weeks 2, 6, 10, 14, 18, 22, and 26, by pill counts. When a patient did not return pills, the patient's self reports were used. Early adherence was defined as > 70% medication intake during the first 10 weeks. Late adherence was defined as > 70% medication intake during the full 26 weeks
Clinical outcomes were measured using: (a) The MINI at baseline and week 26; (b) Clinical Global Impression (CGI) at baseline and all the following visits; (c) The Beck Depression Inventory (BDI) at weeks 2, 6, 10, 18, and 26; and (d) The Symptom Checklist‐90‐Revised (SCL‐90 R) at weeks 2, 10, 18, and 26. The GPs did assessments of adherence, MINI, and CGI and the BDI and SCL‐90 R were self rating questionnaires |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomization was not described in detail. "After agreement to participate, GPs were randomly assigned to either the DCP, or the SFP. Random treatment assignment was placed in advance in a set of sealed, opaque envelopes by an individual who was not involved in the opening of the envelopes. When a GP was randomized, the GP's name and the number of the envelope were recorded before the envelope was opened." (pg 26) |
| Allocation concealment (selection bias) |
Low risk |
Opaque, sealed envelopes used. "After agreement to participate, GPs were randomly assigned to either the DCP, or the SFP. Random treatment assignment was placed in advance in a set of sealed, opaque envelopes by an individual who was not involved in the opening of the envelopes. When a GP was randomized, the GP's name and the number of the envelope were recorded before the envelope was opened." (pg 26) |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol |
| Other bias |
Low risk |
The study seems to be free of other types of bias |
| Blinding of outcome assessment (detection bias)
Adherence measure |
High risk |
(PRIMARY) PILL COUNT ‐ Open‐label trial ‐ the GPs did assessments of adherence, MINI, and CGI. This is a subjective measure |
| Blinding of outcome assessment (detection bias)
Patient outcome |
High risk |
(PRIMARY) MINI INTERNATIONAL NEUROPSYCHIATRIC INTERVIEW ‐ Open‐label trial ‐ the GPs did assessments of adherence, MINI, and CGI. The BDI and SCL‐90 R are self rating questionnaires |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) PILL COUNT ‐ This is a subjective measure; there is no information on blinding |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) MINI INTERNATIONAL NEUROPSYCHIATRIC INTERVIEW ‐ An open‐label trial; this is a subjective measure; there is no information on blinding |
| Blinding of personnel (performance bias)
Adherence measure |
High risk |
(PRIMARY) PILL COUNT ‐ This is a subjective measure; there is no information on blinding |
| Blinding of personnel (performance bias)
Patient outcome |
High risk |
(PRIMARY) MINI INTERNATIONAL NEUROPSYCHIATRIC INTERVIEW ‐ An open‐label trial; this is a subjective measure; there is no information on blinding |
| Incomplete outcome data (attrition bias)
Adherence measure |
High risk |
(PRIMARY) PILL COUNT ‐ Dropouts are not equal across groups but the reasons are provided for some of them; less than 80% of patients followed up at 26 weeks |
| Incomplete outcome data (attrition bias)
Patient outcome |
High risk |
(PRIMARY) MINI INTERNATIONAL NEUROPSYCHIATRIC INTERVIEW ‐ Dropouts are not equal across groups but the reasons are provided for some of them; less than 80% of patients followed up at 26 weeks |
