Introduction

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Both antidepressants and psychological interventions have been shown to be effective in patients with major depression. ^{1 2} The counselling and antidepressants in primary care study was set up to compare the efficacy and cost effectiveness of antidepressant drugs and generic counselling in a naturalistic general practice setting. The short term outcomes from this study (at eight weeks) have been published.³ We report here the outcomes at 12 months.

	Participants and methods

Top Abstract Introduction Participants and methods Results Discussion References

Recruitment and treatment
Full details of the methods have been published.³ Briefly, we invited a random sample of 410 general practices in the Trent health region to enter patients into the trial. General practitioners recruited participants and obtained informed consent. Eligible patients were those aged 18-70 years who met the research diagnostic criteria (assessed by the general practitioner using a checklist) for major depression.⁴ We excluded patients with psychosis, suicidal tendencies, postnatal depression, a recent bereavement, or drug or alcohol misuse. The study was approved by 12 local research ethics committees.

Data collection and follow up
All patients completed the Beck depression inventory⁵ and SF-36 questionnaire at enrolment. ^{6 7} At the follow up visits eight weeks and 12 months after enrolment, the general practitioner completed a form that included the research diagnostic criteria and the patient was asked to complete a form including the Beck depression inventory and SF-36. Patients who did not keep their follow up appointments were asked to complete the forms at home.

Outcome measures
The main outcome measures at 12 months were Beck depression inventory score, time to remission, ^{8 9} global outcome (classified as good, moderate, poor, or unknown), and research diagnostic criteria. Remission was defined as a score of less than 4 on the research diagnostic criteria, a Beck score of less than 10, or clear documentation in the general practitioner's notes that the patient was well. Relapse was defined as deterioration within six months of remission, and recurrence as deterioration after six months of remission.

Statistical analysis
We investigated differences in baseline characteristics and outcome measures between the groups using descriptive statistics, unpaired t tests, ² tests, and Fisher's exact test. The analyses stratified by randomised or patient preference status used Mantel-Haenszel techniques. The time to remission was analysed by the Kaplan-Meier method, and differences were tested with the logrank test. ^{10 11}

	Results

Top Abstract Introduction Participants and methods Results Discussion References

Response rates
The figure shows the numbers of patients recruited and followed up. Sixty five (63%) patients in the randomised trial completed the Beck depression inventory and SF-36 at 12 months compared with 142 (65%) in the patient preference trial. The proportions of patients in each group who kept their 12 month appointment differed (P=0.01), with attendance ranging between 25% for patients choosing antidepressants and 53% for those randomised to antidepressants.

View larger version (33K): [in this window] [in a new window]   Recruitment and follow up of patients

Patient characteristics at entry
The characteristics of randomised patients were comparable at baseline (table 1). Patients preferring counselling were less severely depressed than the randomised patients or those preferring antidepressants.³

Beck inventory scores at 12 months
Mean Beck scores did not differ significantly between the two groups in the randomised controlled trial (P=0.49, table 2). There was no evidence for an interaction between treatment and preference (P=0.6) so we combined the randomised and patient preference groups. Mean Beck scores were similar in counselled patients and those receiving antidepressants.

Global outcome and time to remission
We found no differences in global outcome between the randomised or patient preference trials when outcome was split into good or moderate versus poor (table 3). Stratification by randomised or patient preference status gave similar outcomes for antidepressants and counselling (Mantel Haenszel P=0.63).

Research diagnostic criteria scores
Of the randomised patients who kept their 12 month follow up, nine (47%) in the counselling group were no longer depressed compared with 21 (78%) in the antidepressant group (P=0.07). When we assumed that all those failing to attend had recovered, then 81% in the counselling group and 88% in the antidepressant group were no longer depressed. The figures when we assumed that patients failing to attend were treatment failures were 17% and 41% respectively (P=0.01).

	Discussion

Top Abstract Introduction Participants and methods Results Discussion References

The data from our randomised controlled trial suggest that at 12 months follow up generic counselling and antidepressants are equally effective in patients with mild to moderate depression; remission rates are impressive with both treatments. Patients treated with antidepressants recovered more quickly than those receiving counselling. Choice of treatment seemed to be beneficial, but this applied only to counselling. This finding should be treated with caution as the power of the study to detect interactions was low.

The larger numbers of patients choosing counselling in this trial suggests that patients prefer counselling to antidepressants.³ A survey of people attending general practice had similar findings.¹²

Several caveats must be taken into account when interpreting these data. Firstly, we had difficulty recruiting patients into the randomised controlled trial. The patient preference arms, although increasing the power of the study, tend to make our findings less robust. Secondly, the counselling offered in the study was of a high standard; patients were referred within two weeks, and all the counsellors were experienced. Thirdly, although we found some benefit associated with choice, we did not investigate the effect of giving an alternative treatment to those with a specific preference.

What conclusions should commissioners and general practitioners draw from this study? Firstly, that both counselling and antidepressant drugs are effective, but antidepressants may result in more rapid recovery. Secondly, that given the choice more patients with depression will choose counselling and those who choose antidepressants are likely to be more severely depressed. We recommend that general practitioners should allow patients to have their choice of treatment. However, if the patient does not have a preference, antidepressant drugs should be prescribed because counselling is a scarce resource that is best reserved for those patients who express a preference for it.

	Acknowledgments

We thank Helen Bounds and Joanne Elliott for secretarial and clerical support and Paddy Hawtin for help with data collection. We thank the general practitioners who recruited the patients for this study, and the patients who participated.

Contributors: CC, MD, CD, KF, GH, AL, DW, and IW developed the study protocol. RC, VG, DW, and IW recruited the practices. VG carried out the fieldwork with clinical support from RC. NB, CD, and AL reviewed the case notes and global outcomes. BP, MD, and PM carried out the data analysis. CC wrote the paper, and all authors commented on the drafts. CC and CD are the guarantors.

	Footnotes

Funding: NHS Executive Trent.

Competing interests: None declared.

The full version of this paper appears on the BMJ's website

	References

Top Abstract Introduction Participants and methods Results Discussion References

1.	American Psychiatric Association. Practice guidelines for major depressive disorder in adults. Am J Psychiatry 1993; 150(suppl): 4.
2.	Churchill R, Dewey M, Gretton V, Duggan C, Chilvers C, Lee AS. Should general practitioners refer patients with major depression to counsellors? A review of current published evidence. Br J Gen Pract 1999; 49: 737-743.
3.	Counselling versus Antidepressants in Primary Care Study Group. Assessing treatment effectiveness in depression: results from a PRPT trial. Br J Psychiatry 2000; 177: 312-318[Abstract/Full Text].
4.	Spitzer RL, Endicot J, Robins E. Research diagnostic criteria: rationale and reliability. Arch Gen Psychiatry 1978; 35: 773-782[Medline].
5.	Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J. An inventory for measuring depression. Arch Gen Psychiatry 1961; 4: 561-571.
6.	Brazier JE, Harper R, Jones NMB, O'Cathain A, Thomas KJ, Usherwood T, et al. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ 1992; 305: 160-164[Medline].
7.	Jenkinson C, Coulter A, Wright L. Short form 36 (SF-36) health survey questionnaire: normative data for adults of working age. BMJ 1993; 306: 1437-1440[Medline].
8.	Paykel ES, Priest RG, on behalf of conference participants. Recognition and management of depression in general practice: consensus statement. BMJ 1992; 305: 1198-1202[Medline].
9.	Frank E. Response, remission, recovery, relapse, recurrence. J Clin Psychiatry 1991; 52(suppl 2): 2-16.
10.	Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457-481.
11.	Mantel N, Haenszel P. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 1959; 22: 719-748.
12.	Churchill R, Khaira M, Gretton V, Chilvers C, Dewey M, Duggan C, et al. Treating depression in general practice: factors affecting patients' treatment preferences. Br J Gen Pract 2000; 50: 905-906[Medline].

(Accepted 1 December 2000)