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People with borderline personality disorder frequently experience crises.
To date, no randomised controlled trials (RCTs) of crisis interventions
for this population have been published.
To examine the feasibility of recruiting and retaining adults with
borderline personality disorder to a pilot RCT investigating the
potential efficacy and cost-effectiveness of using a joint crisis
An RCT of joint crisis plans for community-dwelling adults with
borderline personality disorder (trial registration: ISRCTN12440268). The
primary outcome measure was the occurrence of self-harming behaviour over
the 6-month period following randomisation. Secondary outcomes included
depression, anxiety, engagement and satisfaction with services, quality
of life, well-being and cost-effectiveness.
In total, 88 adults out of the 133 referred were eligible and were
randomised to receive a joint crisis plan in addition to treatment as
usual (TAU; n=46) or TAU alone (n=42).
This represented approximately 75% of our target sample size and
follow-up data were collected on 73 (83.0%) participants.
Intention-to-treat analysis revealed no significant differences in the
proportion of participants who reported self-harming (odds ratio (OR)
=1.9, 95% CI 0.53-6.5,P = 0.33) or the frequency of
self-harming behaviour (rate ratio (RR)=0.74, 95% CI 0.34-1.63,
P=0.46) between the two groups at follow-up. No
significant differences were observed between the two groups on any of
the secondary outcome measures or costs.
It is feasible to recruit and retain people with borderline personality
disorder to a trial of joint crisis plans and the intervention appears to
have high face validity with this population. However, we found no
evidence of clinical efficacy in this feasibility study.
Depression is a common and costly comorbidity in dementia. There are very few data on the cost-effectiveness of antidepressants for depression in dementia and their effects on carer outcomes.
To evaluate the cost-effectiveness of sertraline and mirtazapine compared with placebo for depression in dementia.
A pragmatic, multicentre, randomised placebo-controlled trial with a parallel cost-effectiveness analysis (trial registration: ISRCTN88882979 and EudraCT 2006-000105-38). The primary cost-effectiveness analysis compared differences in treatment costs for patients receiving sertraline, mirtazapine or placebo with differences in effectiveness measured by the primary outcome, total Cornell Scale for Depression in Dementia (CSDD) score, over two time periods: 0–13 weeks and 0–39 weeks. The secondary evaluation was a cost-utility analysis using quality-adjusted life years (QALYs) computed from the Euro-Qual (EQ-5D) and societal weights over those same periods.
There were 339 participants randomised and 326 with costs data (111 placebo, 107 sertraline, 108 mirtazapine). For the primary outcome, decrease in depression, mirtazapine and sertraline were not cost-effective compared with placebo. However, examining secondary outcomes, the time spent by unpaid carers caring for participants in the mirtazapine group was almost half that for patients receiving placebo (6.74 v. 12.27 hours per week) or sertraline (6.74 v. 12.32 hours per week). Informal care costs over 39 weeks were £1510 and £1522 less for the mirtazapine group compared with placebo and sertraline respectively.
In terms of reducing depression, mirtazapine and sertraline were not cost-effective for treating depression in dementia. However, mirtazapine does appear likely to have been cost-effective if costing includes the impact on unpaid carers and with quality of life included in the outcome. Unpaid (family) carer costs were lower with mirtazapine than sertraline or placebo. This may have been mediated via the putative ability of mirtazapine to ameliorate sleep disturbances and anxiety. Given the priority and the potential value of supporting family carers of people with dementia, further research is warranted to investigate the potential of mirtazapine to help with behavioural and psychological symptoms in dementia and in supporting carers.
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