scholarly journals A new generation of pragmatic trials of psychosocial interventions is needed

2013 ◽  
Vol 22 (2) ◽  
pp. 111-117 ◽  
Author(s):  
M. Ruggeri ◽  
A. Lasalvia ◽  
C. Bonetto

This Editorial addresses the crucial issue of which research methodology is most suited for capturing the complexity of psychosocial interventions conducted in ‘real world’ mental health settings. It first examines conventional randomized controlled trial (RCT) methodology and critically appraises its strengths and weaknesses. It then considers the specificity of mental health care treatments and defines the term ‘complex’ intervention and its implications for RCT design. The salient features of pragmatic RCTs aimed at generating evidence of psychosocial intervention effectiveness are then described. Subsequently, the conceptualization of pragmatic RCTs, and of their further developments – which we propose to call ‘new generation’ pragmatic trials – in the broader routine mental health service context, is explored. Helpful tools for planning pragmatic RCTs, such as the CONSORT extension for pragmatic trials, and the PRECIS tool are also examined. We then discuss some practical challenges that are involved in the design and implementation of pragmatic trials based on our own experience in conducting the GET UP PIANO Trial. Lastly, we speculate on the ways in which current ideas on the purpose, scope and ethics of mental health care research may determine further challenges for clinical research and evidence-based practice.

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
M Knapstad ◽  
L V Lervik ◽  
S M M Saether ◽  
L E Aaroe ◽  
O R F Smith

Abstract Background Prompt Mental Health Care (PMHC) service is a Norwegian initiative, adapted from the English ‘Improved Access to Psychological Therapy’ (IAPT), aimed at improving access to primary care treatment for anxiety and depression. Thus far, both PMHC and IAPT have been evaluated by cohort studies only. Albeit yielding promising results, the extent to which these are attributable to the treatment thus remains unsettled. This study investigates the effectiveness of PMHC compared to treatment as usual (TAU) at six months follow-up. Methods Randomized controlled trial with parallel assignment in two PMHC sites from November 2015 to March 2018. Participants were 681 adults (aged ≥18 years) considered for admission to PMHC due to anxiety and/or mild to moderate depression. These were randomly assigned on a 70:30 ratio. Main outcomes were recovery rates and changes in symptoms of depression and anxiety between baseline and follow-up. Primary outcome data were available for 73%/67% in the PMHC/TAU group. Sensitivity analyses based on observed patterns of missingness were conducted. Results A reliable recovery rate of 58.5% was observed in the PMHC group and 31.9% in the TAU group, yielding a between-group effect size (ES) of 0.61 [95% CI 0.37-0.85, p<.001]. The differences in degree of improvement between PMHC and TAU yielded an ES of -0.88 [95% CI -1.23-0.43, p < 0.001] for symptoms of depression and -0.60 [95% CI -0.90-0.30, p < 0.001] for symptoms of anxiety in favour of PMHC. All sensitivity analyses pointed in the same direction with small variations in point estimates. Findings were slightly more robust for depressive than anxiety symptoms. Conclusions The PMHC treatment was substantially more effective than TAU in alleviating symptoms of anxiety and depression. This adaptation of IAPT is considered a viable supplement to existing health services to increase access of effective treatment for adults who suffer from anxiety and mild to moderate depression. Key messages This study is the first to evaluate the effectiveness of an IAPT-like treatment model in terms of a randomized controlled trial. Prompt Mental Health Care was substantially more effective than TAU in alleviating symptoms of depression and anxiety at 6-months follow-up.


2019 ◽  
Vol 89 (2) ◽  
pp. 90-105 ◽  
Author(s):  
Marit Knapstad ◽  
Linn Vathne Lervik ◽  
Solbjørg Makalani Myrtveit Sæther ◽  
Leif Edvard Aarø ◽  
Otto Robert F. Smith

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