BackgroundWe hypothesised that a multi-modal psychosocial intervention (PSI) after first episodes of non-affective psychosis would increase antipsychotic adherence, improve functioning and prevent readmission in a multi-centre, blind-rated, randomised controlled trial.MethodsFollowing treatment of first episode non-affective psychosis with amisulpride, olanzapine or clozapine (those remitting after phases 1–3 of the OPTIMISE program or dropping-out but willing to enter the adherence trial) patients with DSM-IV schizophreniform disorder, schizophrenia, or schizoaffective disorder were eligible for allocation to PSI or treatment as usual (TAU).PSI involved: i) e-learning via a psychoeducational website; ii) mHealth intervention with 3 months SMS medication reminders configured by participants; iii) motivational interviewing targeting adherence over 6 weeks.Primary outcome measures at 3 and 12 month follow-up were Compliance Rating Scale (score 1–7 worst to best), and Social and Occupational Function Assessment Scale (SOFAS; 0–100). Secondary outcomes included remission, Drug Attitudes Inventory (DAI), and EuroQoL quality of life scale. We present interim analyses of 3 month data with general linear and logistic regression models, clustered by centre and adjusted for baseline scores and demographics.ResultsRecruitment time, now finished, was extended to reach target sample size, so 12 month data are incomplete. 258 were allocated to PSI or TAU. 18 dropped-out before baseline assessment: 240 entered the modified intention to treat analysis (PSI 121, TAU 119). After PSI, 71% were followed-up at 3 months; after TAU, 80%. No baseline variable significantly predicted this attrition.Webpages covering illness and treatment had 244–290 hits each. Only 24% of the PSI group set up SMS text reminders. At least 70% attended motivational interviewing, 77% of these for all sessions. Mean California Patient Alliance Scale item score was 5.2 (95% Confidence Interval, CI, 5.0, 5.3; score 1–7 poor-good).Mean baseline SOFAS (SD) for the PSI group was 62 (14); for TAU 62 (15). General linear modelling of 12 week data included baseline CRS and drug attitudes: marginal mean SOFAS after PSI was 65.3 (CI 62.6, 68.0) and after TAU 61.4 (CI 59.3, 63.4; p0.025; standardised effect size Glass’ Δ=0.41). Median (IQR) compliance score was 6 (5,7) at baseline for PSI and 6 (6,7) for TAU; and 6 (5,7) at 3 months in both groups (ordinal logistic regression, p0.36).In secondary analyses 3 month DAI did not differ significantly between PSI and TAU (marginal means 13.5 v 11.5, bootstrapped p0.164). EuroQoL wellbeing score was significantly better after PSI (marginal means 76.0 v 69.1, bootstrapped p0.003) and remission was significantly commoner (72 v 54%, binary logistic regression p0.007). No analysis result was sensitive to probability weighted adjustment for drop out.DiscussionInterim analyses indicate that immediately after PSI social function and wellbeing improved significantly and remission was commoner. Adherence and DAI did not differ significantly. Either PSI’s immediate benefits were non-specific or adherence measures failed to capture its effect. Longer term effects are unclear until definitive analyses planned before 2018.
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