Participant flow and follow up
Of 266 patients referred, eight were excluded (three glaucoma, one recent myocardial infarction, one recent dothiepin treatment, one too confused to consent, two left area immediately after referral) and eight declined to participate, leaving 250 eligible subjects (94%). Thirty seven were allocated to the attention control group, and 213 were randomised (table ). Eighty eight patients had their adherence monitored; 84 container lids were evaluable.
Flow of patients entered into randomisation
The response rate to the bias questionnaire was 77%: six general practitioners (13%) had retired or left the area, and five (10%) did not respond. The commonest reason given for not entering patients was that the general practitioner was “too busy” or “forgot about the study.” General practitioners reported entering fewer patients with chronic depression (54%), comorbid physical illness (51%), postnatal depression (39%), and older patients (25%).
Table shows the characteristics of patients. Half met criteria for major depressive episode within the past month. Almost two thirds had had previous treatment for depression, usually drugs from their general practitioner.
Characteristics of participants at baseline. Values are numbers (percentages) unless stated otherwise
Delivery of interventions
Of 105 patients allocated to drug counselling, 89 (85%) received a first visit, and 73 (70%) received both (table ). Visits were cancelled if drug treatment had been discontinued. At 2 weeks, 11 patients (10%) had discontinued drugs and five patients (5%) refused the visit. At 8 weeks, 20 patients (19%) had stopped drugs and eight (8%) refused. The mean durations of the two visits were 45 (SD 15) min and 33 (SD 13) min.
Patients allocated to receive a leaflet were asked whether they recalled receiving it: 82 (78%) did. Ten patients received more than one leaflet, and 18 not allocated to receive a leaflet reported receiving one from elsewhere (doctor or pharmacist).
Table shows self reported adherence to drug treatment. The proportion of controls continuing treatment at week 12 was 19/37 (51%). In logistic regression, allocation to counselling was a significant predictor of self reported adherence (6 weeks: odds ratio 2.1, 95% confidence interval 1.1 to 4.0; 12 weeks: 2.7, 1.6 to 4.8; number needed to treat =4) but allocation to receive a leaflet was not (6 weeks: 1.0, 0.55 to 1.9; 12 weeks: 1.1, 0.64 to 2.0). There was no significant interaction between treatments. Sex, previous treatment, initial depression severity, and drug dose did not materially influence the findings. Subgroup analysis of patients meeting criteria for major depressive episode showed that drug counselling had a significant effect on adherence (χ2= 6.33, df =1, P=0.012) but the leaflet did not.
Proportion of patients reporting continuing treatment at 6 and 12 weeks
The figure shows the survival analysis. The analysis confirmed that allocation to counselling had a significant effect compared with usual treatment (mean treatment duration 87 (SE 4) v 63 (4) days, log rank test 10.83, df=1, P=0.001; hazard ratio=2.1, 95% confidence interval 1.3 to 3.2); allocation to leaflet had no effect (hazard ratio=1.1, 0.72 to 1.6).
Adherence was monitored in a subgroup of patients to check the validity of self reported adherence. There was no difference in self reported adherence between monitored patients and other patients. Self reported and monitored adherence were significantly related (mean duration of monitored treatment 41.7 (SD 5.8) days in patients reporting continuation compared with 26.1 (SD 15.9) days in those reporting cessation, t=6.6, df=82, P<0.001). In the monitored group there was a trend towards higher adherence among those who had drug counselling (Mann-Whitney z =1.72, P=0.08).
Although counselling increased both self reported and monitored adherence, we found no overall effect on outcome of depression. All patients showed considerable improvement at 12 weeks (depression score 4.6 (SD 4.5) in counselled patients v 5.5 (SD 3.6) in those with no intervention, t=1.55, df=199, P=0.124). However, change in depression score and number of days of treatment were significantly correlated (ρ=0.264, P<0.0001), and patients who had met criteria for major depression at the outset and received doses above the median value of 75 mg had a significant difference in depression score (4.0 (SD 3.7) v 5.9 (SD 5.0), t=2.18, P=0.032).
No overall differences in SF-36 subscales were found, but among patients receiving doses of at least 75 mg drug counselling had a significant effect on scores on the mental health subscale (68.4 (SD 15.8) v 60.8 (SD 22.6), t=1.98, df =97, P=0.05). In subjects who had major depression and received doses of 75 mg or more this difference reached significance (64.9 (SD 14.5) v 54.0 (SD 23.5), t=2.1, df=53, P=0.038). Counselling had no significant effect on the number of general practitioner visits, hospital admissions, or time off work.