Discontinuing financial incentives for adherence to antipsychotic depot medication: long-term outcomes of a cluster randomised controlled trial

Objectives: In a cluster randomised controlled trial, offering financial incentives improved adherence to antipsychotic depot medication over a 1-year period. Yet, it is unknown whether this positive effect is sustained once the incentives stop. Methods and analyses: Patients in the intervention and control group were followed up for 2 years after the intervention. Primary and secondary outcomes were assessed at 6 months and 24 months post intervention. Assessments were conducted between September 2011 and November 2014. Results: After the intervention period, intervention and control groups did not show any statistically significant differences in adherence, neither in the first 6 months (71% and 77%, respectively) nor in the following 18 months (68%, 74%). There were no statistically significant differences in secondary outcomes, that is, adherence ≥95% and untoward incidents either. Conclusions: It may be concluded that incentives to improve adherence to antipsychotic maintenance medication are effective only for as long as they are provided. Once they are stopped, adherence returns to approximately baseline level with no sustained benefit. Trial registration number: ISRCTN77769281

The Dynamics of Mood and Coping in Bipolar Disorder: Longitudinal Investigations of the Inter-Relationship between Affect, Self-Esteem and Response Styles

BACKGROUND: Previous research has suggested that the way bipolar patients respond to depressive mood impacts on the future course of the illness, with rumination prolonging depression and risk-taking possibly triggering hypomania. However, the relationship over time between variables such as mood, self-esteem, and response style to negative affect is complex and has not been directly examined in any previous study--an important limitation, which the present study seeks to address. METHODS: In order to maximize ecological validity, individuals diagnosed with bipolar disorder (N = 48) reported mood, self-esteem and response styles to depression, together with contextual information, up to 60 times over a period of six days, using experience sampling diaries. Entries were cued by quasi-random bleeps from digital watches. Longitudinal multilevel models were estimated, with mood and self-esteem as predictors of subsequent response styles. Similar models were then estimated with response styles as predictors of subsequent mood and self-esteem. Cross-sectional associations of daily-life correlates with symptoms were also examined. RESULTS: Cross-sectionally, symptoms of depression as well as mania were significantly related to low mood and self-esteem, and their increased fluctuations. Longitudinally, low mood significantly predicted rumination, and engaging in rumination dampened mood at the subsequent time point. Furthermore, high positive mood (marginally) instigated high risk-taking, and in turn engaging in risk-taking resulted in increased positive mood. Adaptive coping (i.e. problem-solving and distraction) was found to be an effective coping style in improving mood and self-esteem. CONCLUSIONS: This study is the first to directly test the relevance of response style theory, originally developed to explain unipolar depression, to understand symptom changes in bipolar disorder patients. The findings show that response styles significantly impact on subsequent mood but some of these effects are modulated by current mood state. Theoretical and clinical implications are discussed

Evaluating the effectiveness and cost effectiveness of the 'strengthening families, strengthening communities' group-based parenting programme: study protocol and initial insights.

Funder: Public Health Research Programme; Grant(s): NIHR-PHR: 16/122/35BACKGROUND: Up to 20% of UK children experience socio-emotional difficulties which can have serious implications for themselves, their families and society. Stark socioeconomic and ethnic inequalities in children's well-being exist. Supporting parents to develop effective parenting skills is an important preventive strategy in reducing inequalities. Parenting interventions have been developed, which aim to reduce the severity and impact of these difficulties. However, most parenting interventions in the UK focus on early childhood (0-10 years) and often fail to engage families from ethnic minority groups and those living in poverty. Strengthening Families, Strengthening Communities (SFSC) is a parenting programme designed by the Race Equality Foundation, which aims to address this gap. Evidence from preliminary studies is encouraging, but no randomised controlled trials have been undertaken so far. METHODS/DESIGN: The TOGETHER study is a multi-centre, waiting list controlled, randomised trial, which aims to test the effectiveness of SFSC in families with children aged 3-18 across seven urban areas in England with ethnically and socially diverse populations. The primary outcome is parental mental well-being (assessed by the Warwick-Edinburgh Mental Well-Being Scale). Secondary outcomes include child socio-emotional well-being, parenting practices, family relationships, self-efficacy, quality of life, and community engagement. Outcomes are assessed at baseline, post intervention, three- and six-months post intervention. Cost effectiveness will be estimated using a cost-utility analysis and cost-consequences analysis. The study is conducted in two stages. Stage 1 comprised a 6-month internal pilot to determine the feasibility of the trial. A set of progression criteria were developed to determine whether the stage 2 main trial should proceed. An embedded process evaluation will assess the fidelity and acceptability of the intervention. DISCUSSION: In this paper we provide details of the study protocol for this trial. We also describe challenges to implementing the protocol and how these were addressed. Once completed, if beneficial effects on both parental and child outcomes are found, the impact, both immediate and longer term, are potentially significant. As the intervention focuses on supporting families living in poverty and those from minority ethnic communities, the intervention should also ultimately have a beneficial impact on reducing health inequalities. TRIAL REGISTRATION: Prospectively registered Randomised Controlled Trial ISRCTN15194500

The effect of financial incentives on adherence to antipsychotic depot medication: does it change over time?

Objective: A recent cluster-randomized controlled trial found that offering financial incentives improves adherence to long-acting injectable antipsychotics (LAIs). The present study investigates whether the impact of incentives diminishes over time and whether the improvement in adherence is linked to the amount of incentives offered. Method: Seventy-three teams with 141 patients with psychotic disorders (using ICD-10) were randomized to the intervention or control group. Over 1 year, patients in the intervention group received £15 (US $23) for each LAI, while control patients received treatment as usual. Adherence levels, ie, the percentage of prescribed LAIs that were received, were calculated for quarterly intervals. The amount of incentives offered was calculated from the treatment cycle at baseline. Multilevel models were used to examine the time course of the effect of incentives and the effect of the amount of incentives offered on adherence. Results: Adherence increased in both the intervention and the control group over time by an average of 4.2% per quarterly interval (95% CI, 2.8%–5.6%; P < .001). Despite this general increase, adherence in the intervention group remained improved compared to the control group by between 11% and 14% per quarterly interval. There was no interaction effect between time and treatment group. Further, a higher total amount of incentives was associated with poorer adherence (βbootstrapped = −0.11; 95% CIbootstrapped, −0.20 to −0.01; P = .023). Conclusions: A substantial effect of financial incentives on adherence to LAIs occurs within the first 3 months of the intervention and is sustained over 1 year. A higher total amount of incentives does not increase the effect. Trial Registration: ISRCTN.com identifier: ISRCTN77769281 and UKCRN.org identifier: 703

Regression estimates (β) and bias corrected 95% CI for the longitudinal effect of PA, NA, and SE at time T-1 on response styles at time T.

<p>Note: PA = positive affect; NA = negative affect; SE = self-esteem;</p>*<p><i>p</i><.05,</p>**<p><i>p</i><.01</p>***<p> = <i>p</i><.001,</p><p>ns = non-significant;</p>a<p>entered into model as a separate predictor;</p>b<p>entered into model simultaneously.</p>¶<p>denotes <i>p</i> = .071.</p

Sample characteristics (N = 48).

<p>Note: HRSD = The Hamilton rating scale for depression; MAS = The Bech-Refaelson mania scale.</p

Regression estimates (β) and bias corrected 95% CI for the longitudinal effect of rumination, adaptive coping and risk-taking at time T-1 on momentary levels of PA, NA, and SE at time T1.

<p>Note: PA = positive affect; NA = negative affect; S-E = self-esteem;</p>*<p><i>p</i><.05,</p>**<p><i>p</i><.01</p>***<p><i>p</i><.001,</p><p>ns = non-significant;</p>a<p>entered into model as a separate predictor;</p>b<p>entered into model simultaneously.</p>¶<p>denotes <i>p</i> = 0.050;</p>¶¶<p>denotes = .079.</p

Regression estimates (β) and bias corrected 95% CI for the cross-sectional effects of depression (HRSD) and mania (MAS) on momentary levels of negative (NA) and positive affect (PA) and their fluctuations over time, and on response styles (rumination, adaptive-coping and risk-taking).

<p>Note: HRSD = The Hamilton rating scale for depression; MAS = The Bech-Refaelson mania scale;</p>**<p><i>p<</i>.01;</p>***<p><i>p<</i>.001<i>;</i> ns = not significant.</p