Ninety four patients met the criteria for schizophrenia, of whom six were ineligible (five had an IQ < 80, and one person was not fluent in English) and 32 declined to enter the trial. A greater proportion of women than men declined to participate in the trial (15/30 (50%) v 18/59 (30%), P = 0.073), and those who refused to participate were significantly older than those who agreed (mean (SD) age 36.95 (11.48) v 31.98 (8.93), difference 4.97 (95% confidence interval 0.58 to 9.38), P = 0.028).
The 56 people who consented to enter the study were randomly allocated equally to the two therapies. Six patients were lost to follow up: two dropped out during therapy (both controls); three (two controls, one compliance therapy) refused follow up, and one (compliance therapy) died in the follow up period (see ).
Recruitment of participants and their progress through the trial
Baseline compliance could not be measured for the 12 patients who were admitted for their first episode of schizophrenia, five of whom were allocated to compliance therapy and seven to control therapy. Patients randomised to compliance therapy did not differ from control patients in terms of baseline compliance (8/23 v 4/21, odds ratio 2.267 (95% confidence interval 0.474 to 11.41)), attitudes to medication, insight, symptomatology, level of functioning, or quality of life ().
Baseline sociodemographic and clinical characteristics of patients with schizophrenia who received compliance therapy or non-specific counselling. Values are numbers of patients unless stated otherwise
Compliance therapy conferred no advantage over non-specific therapy in terms of compliance at one year (12/28 v 15/28, odds ratio 0.65 (0.197 to 2.123)) or the secondary outcome measures—symptomatology (mean (SD) symptoms scale 58.2 (17) v 52.1 (21), difference 6.1 (-4.7 to 16.9), P = 0.26), attitudes to treatment (51.3 (8.2) v 53.4 (6.2), difference -2.1 (-6.3 to 2.1), P = 0.32), insight (9.9 (4.1) v 10.4 (2.8), difference -0.5 (-2.4 to 1.5), P = 0.65), level of functioning (52.7 (17.8) v 56.9 (25.3), difference -4.2 (-16.8 to 8.4), P = 0.50), and quality of life (71.8 (21) v 75.2 (25), difference -3.4 (-16.6 to 9.9), P = 0.61).
Patients who received compliance therapy were not significantly different from control patients in terms of occupancy of psychiatric hospital beds at one year follow up (mean (SD) number of bed days 26 (45) v 33 (57), difference -7 (-35 to 21), P = 0.61) and at two years (43(60) v 50 (70), difference -7 (-42 to 28), P = 0.69). Survival in the community, measured by the number of days to first readmission to psychiatric hospital, was not significantly different for the two groups of patients (mean 440 days (95% confidence interval 346 to 534) for compliance therapy v 482 days (378 to 586) for control).
Predictors of compliance at one year
A logistic regression model (for the 44 patients with complete baseline data) identified baseline compliance, baseline attitudes to treatment, female sex, and carer involvement as predictors of compliance at one year follow up (). Undergoing compliance therapy was not a predictor of compliance at one year. Olfson et al had found that refusal by patients' families to become involved in treatment predicted patients' non-compliance.16
We therefore included carer attendance at an education programme in our model as an indicator of willingness to become involved in treatment care, and this was a predictor of compliance at one year.
Baseline predictors of optimal compliance with drug treatment at one year among patients with schizophrenia with full baseline date (n=44). Results of binary logistic regression analysis (intention to treat analysis)