Baseline
One hundred and eighty patients were referred to the trial from 62 primary care health professionals: 52 GPs (based at 26 different practices), four district nurses, four practice nurses, one case manager, and one specialist heart failure nurse. Of the 180 patients referred, 105 were subsequently randomised (Figure 1). Table 1 summarises the characteristics of patients at baseline. Mean age of all patients was 75.5 years (range = 60–92 years); 72%(76/105) were female; 41% (43/105) were widowed; and 53% (56/105) were living independently in their own homes. Very few patients were in residential care (2/105). Mean number of symptoms at baseline using the SCID depression scale checklist was 5.8 (range = 2–9). On the SCID, five or more symptoms indicates an episode of major depression disorder.
Figure 1 Referral and randomisation of participants.
Table 1 Patient characteristics at baseline.
HAQ disability is scored from 0 (not disabled) to 3 (disabled in every category). HAQ pain is scored from 0 (in no pain) to 3 (in the most pain). On the HAQ the mean disability score was 0.82 (range = 0–2.5). The mean pain score was 0.86 (range = 0–2.8).
Follow up
At 16-weeks' follow up three patients in the intervention group and four receiving usual care died (none from suicide or for reasons attributable to depression or treatment). Three of the intervention group declined follow up, one was lost to follow up (having moved house), and one was referred to secondary care old-age psychiatry. Four of the usual care group declined follow up and one was lost to follow up. Table 2 presents outcomes at 16 weeks. Significant beneficial effects of randomisation to the intervention group were apparent using the SCID depression scale. In the intervention group 20% (9/45) had 5 or more symptoms compared with 40% (17/43) in the group receiving usual care. The adjusted odds ratio of being ‘depressed’ in the intervention group compared with treatment as usual was 0.32 (95% confidence interval [CI] = 0.11 to 0.93, P = 0.036). When referral to secondary care, declined follow up, and loss-to-follow up were included as adverse outcomes, the adjusted odds ratio was 0.38 (95%CI = 0.15 to 0.97, P = 0.042).
Table 2 summarises the analysis of quantitative outcomes scales. Because the measures were non-normal and showed evidence of skewness for quantitative outcomes, the robustness of the parametric analysis presented was checked using a non-parametric bootstrap.26 For all outcomes these bootstrap CIs were very similar but slightly narrower. On the SCID intervention patients had a better outcome than treatment as usual patients (P = 0.036). The HSCL-20 was not significant (P = 0.062). There was no evidence of benefit for the intervention group on the HAQ pain and disability measures.
Table 2 Baseline and 16 weeks for quantitative outcome measure.
Defining the intervention
Qualitative interviews were semi-structured and formed the basis of a dialogue between interviewer and responder (patients and practitioners). Patients were asked their views about the causes of depression, their help-seeking behaviour, relationship with primary care professionals, and how they felt about treatment options offered to them. In later interviews patients were asked about their experiences of the intervention. Analysis of early interviews with patients revealed that they had limited expectations of treatment (reported previously18):
Interviewer: ‘Going back to depression, do you know much about it?’
Responder: ‘No, not a lot.’
I: ‘Do you know what sort of treatments might be available?’
R: ‘No.’
I: ‘Had you ever heard of it before you got depressed?’
R: ‘My doctor knew, he knows me inside out. He knew immediately. He's a lovely doctor.’ (ID 48)
Interviews conducted at the end of the intervention explored with patients their recall of communication with the trial nurse and their views about and attitudes towards these contacts. The intervention was acceptable to most patients. Face-to-face contact was preferred to telephone consultations, unlike studies from the US:11
I: ‘When he rang you up, did you find that useful?’
R: ‘Well he just said how are you going … just a quick telephone call, nothing very important really.’ (ID 42)
The personal qualities of the trial nurse in making patients feel listened to and supported were detailed by patients:
‘I couldn't fault himin any way. He was brilliant with me. If he goes elsewhere and they say different, then it's something where they are not actually connecting with him. They're not reaching out to him. As I say, I could talk to me daughters but with [the CPN] I could talk about anything, anything that was worrying me and the way I felt. I found that connection; so whatever I said I was getting a comeback and good advice and helpfulness. I'll tell you what, I'd have him back here next week because he is brilliant.’ (ID 42)
‘I found him very, very … I found him a very nice chap. He was somebody that you could have a conversation with which is, I mean today I can go in places, pubs, and everywhere like that, you can't get a conversation.’ (ID 55).
In contrast was the poorer recall of the specific components of SHADE, although some components, such as keeping a diary and setting goals, relaxation, and behavioural activation were described by some patients. However, descriptions of the use of the SHADE manual were limited:
‘Well [the CPN] left me this great [large] book thing. I didn't feel like doing anything about that. I couldn't get into it at all. I couldn't concentrate on it. So I left it. I thought he'd be annoyed … but he wasn't.’ (ID 41)
The trial nurse described the theoretical basis and process of his work, and the use of the self-help intervention in detail. He disclosed that what he perceived was most valuable to patients was personal contact with someone who was empathic and showed interest in the patient as an individual:
‘Depression isn't loneliness. I mean I'm very clear that it's not the same thing. But, one of the themes that comes through people I see, it's a very high percentage of the people when I start looking through the records, the word loneliness comes up or at least isolation … What I tend to do, I try and focus in on things that I can get them to talk about, because I genuinely believe that everyone has a story to tell and that's the first bit of engagement. You know there's no matter how depressed people are, it's trying to re-humanise [them] … It's trying to find what maybe we've got in common. How I can gauge someone, how I can get them on board … So the more I can know about them, not necessarily about their illness, about them as a person.’
The nurse described using components of SHADE flexibly and agreed which components would be used through negotiation with individual patients:
‘It is very very flexible … if someone asked me what I was really doing I'd say I use a very eclectic common sense non-rocket-science approach, that's very, very individual to whatever the patient's needs are.’
