Developing guided self-help for depression using the Medical Research Council complex interventions framework: a description of the modelling phase and results of an exploratory randomised controlled trial
Abstract:Background: Current guidelines for the management of depression suggest the use of guided selfhelp for patients with mild to moderate disorders. However, there is little consensus concerning the optimal form and delivery of this intervention. To develop acceptable and effective interventions, a phased process has been proposed, using a modelling phase to examine and develop an intervention prior to preliminary testing in an exploratory trial. This paper (a) describes the modelling phase used to develop a guide… Show more
“…GPs were asked to complete two postal questionnaire surveys which included clinical scenariosFindings encouraged the development of a replicable methodology for the design, evaluation and refinement of interventions prior to service-level RCTsKirkevold et al 2012 [31]Norwaynursing intervention for psychological health and well-being after strokeMRC framework 2000 and 2008Evaluate and critique the intervention by patient and relative representatives, clinical experts and researchersConsensus process involving a wide range of healthcare professionals patients representatives and family carersThe intervention was refined and then tested in a feasibility studyLewis et al 2013 [28]UKGuided self-help (GSH) intervention for the treatment of mild-to-moderate post-traumatic stress disorder (PTSD)MRC framework 2000 and 2008Test the intervention potential effect and stakeholders’ perspective in order to refine the intervention2 small-scale and uncontrolled pilot studies ( n = 10 and n = 9) including pre and post treatment quantitative data, interviews with participants taking part in the pilots and focus groups with healthcare professionals and stakeholders involved in the development of the prototypeFindings from the first pilot led to the development of the intervention prototype, which was then tested in a second pilot. Results were used to refine the programme in order to produce the finalised programmeLovell et al 2008 [35]UKGuided self-help intervention for depression in primary careMRC framework 2000Synthesise available evidence on the effectiveness of the intervention, identify key factors that may moderate effectiveness and deal with uncertainties emerging from the reviews, assess of acceptability to patients and healthcare professionalsMeta-regression, meta-analysis and a consensus process with experts, including academics ( n = 8), health professionals ( n = 10) and service users ( n = 1), phone interviews with patients and healthcare professionalsThe integration of findings allowed identifying the ‘core components’ of the intervention, which was then tested in feasibility study. The intervention did not moved to the RCT phase, as it did not markedly improve outcomes in the exploratory studyMunir et al 2013 [42]UKWork-related guidance tool for people with/recovering from cancerIntervention mapping [36]Obtain consensus on the questions included in the guidance tool (a list of 43 questions was previously developed) and to which healthcare professional these should be asked, and test feasibility of the intervention to participantsA two-round Delphi study conducted online with 172 experts (round 1) and 139 experts (round 2); online survey to participants ( n = 38) who tested the guideline tool for six weeksThe intervention was finalised by identifying the key components of the tool and a range of stakeholders and the tested in a feasibility studyMurchie et al 2007 [37]UKFollow-up programme for people treated for cutaneous malignant melanomaMRC framework 2000Seek patients...…”
BackgroundMany complex intervention trials fail to show an intervention effect. Although this may be due to genuine ineffectiveness, it may also be the result of sub-optimal intervention design, implementation failure or a combination of these. Given current financial constraints and the pressure to reduce waste and increase value in health services research, pre-trial strategies are needed to reduce the likelihood of design or implementation failure and to maximise the intervention’s potential for effectiveness. In this scoping review, we aimed to identify and synthesise the available evidence relating to the strategies and methods used to ‘optimise’ complex interventions at the pre-trial stage.MethodsWe searched MEDLINE, CINAHL, AMED, PsycINFO and ProQuest Nursing & Allied Health Source for papers published between January 2000 and March 2015. We included intervention development and optimisation studies that explored potential intervention weaknesses and limitations before moving to a definitive randomised controlled trial (RCT). Two reviewers independently applied selection criteria and systematically extracted information relating to the following: study characteristics; intervention under development; framework used to guide the development process; areas of focus of the optimisation process, methods used and outcomes of the optimisation process. Data were tabulated and summarised in a narrative format.ResultsWe screened 3968 titles and 231 abstracts for eligibility. Eighty-nine full-text papers were retrieved; 27 studies met our selection criteria. Optimisation strategies were used for a range of reasons: to explore the feasibility and acceptability of the intervention to patients and healthcare professionals; to estimate the effectiveness and cost-effectiveness of different combinations of intervention components; and to identify potential barriers to implementation. Methods varied widely across studies, from interviews and focus groups to economic modelling and probability analysis.ConclusionsThe review identifies a range of optimisation strategies currently used. Although a preliminary classification of these strategies can be proposed, a series of questions remain as to which methods to use for different interventions and how to determine when the intervention is ready or ‘optimised enough’ to be tested in a RCT. Future research should explore potential answers to the questions raised, to guide researchers in the development and evaluation of more effective interventions.
“…GPs were asked to complete two postal questionnaire surveys which included clinical scenariosFindings encouraged the development of a replicable methodology for the design, evaluation and refinement of interventions prior to service-level RCTsKirkevold et al 2012 [31]Norwaynursing intervention for psychological health and well-being after strokeMRC framework 2000 and 2008Evaluate and critique the intervention by patient and relative representatives, clinical experts and researchersConsensus process involving a wide range of healthcare professionals patients representatives and family carersThe intervention was refined and then tested in a feasibility studyLewis et al 2013 [28]UKGuided self-help (GSH) intervention for the treatment of mild-to-moderate post-traumatic stress disorder (PTSD)MRC framework 2000 and 2008Test the intervention potential effect and stakeholders’ perspective in order to refine the intervention2 small-scale and uncontrolled pilot studies ( n = 10 and n = 9) including pre and post treatment quantitative data, interviews with participants taking part in the pilots and focus groups with healthcare professionals and stakeholders involved in the development of the prototypeFindings from the first pilot led to the development of the intervention prototype, which was then tested in a second pilot. Results were used to refine the programme in order to produce the finalised programmeLovell et al 2008 [35]UKGuided self-help intervention for depression in primary careMRC framework 2000Synthesise available evidence on the effectiveness of the intervention, identify key factors that may moderate effectiveness and deal with uncertainties emerging from the reviews, assess of acceptability to patients and healthcare professionalsMeta-regression, meta-analysis and a consensus process with experts, including academics ( n = 8), health professionals ( n = 10) and service users ( n = 1), phone interviews with patients and healthcare professionalsThe integration of findings allowed identifying the ‘core components’ of the intervention, which was then tested in feasibility study. The intervention did not moved to the RCT phase, as it did not markedly improve outcomes in the exploratory studyMunir et al 2013 [42]UKWork-related guidance tool for people with/recovering from cancerIntervention mapping [36]Obtain consensus on the questions included in the guidance tool (a list of 43 questions was previously developed) and to which healthcare professional these should be asked, and test feasibility of the intervention to participantsA two-round Delphi study conducted online with 172 experts (round 1) and 139 experts (round 2); online survey to participants ( n = 38) who tested the guideline tool for six weeksThe intervention was finalised by identifying the key components of the tool and a range of stakeholders and the tested in a feasibility studyMurchie et al 2007 [37]UKFollow-up programme for people treated for cutaneous malignant melanomaMRC framework 2000Seek patients...…”
BackgroundMany complex intervention trials fail to show an intervention effect. Although this may be due to genuine ineffectiveness, it may also be the result of sub-optimal intervention design, implementation failure or a combination of these. Given current financial constraints and the pressure to reduce waste and increase value in health services research, pre-trial strategies are needed to reduce the likelihood of design or implementation failure and to maximise the intervention’s potential for effectiveness. In this scoping review, we aimed to identify and synthesise the available evidence relating to the strategies and methods used to ‘optimise’ complex interventions at the pre-trial stage.MethodsWe searched MEDLINE, CINAHL, AMED, PsycINFO and ProQuest Nursing & Allied Health Source for papers published between January 2000 and March 2015. We included intervention development and optimisation studies that explored potential intervention weaknesses and limitations before moving to a definitive randomised controlled trial (RCT). Two reviewers independently applied selection criteria and systematically extracted information relating to the following: study characteristics; intervention under development; framework used to guide the development process; areas of focus of the optimisation process, methods used and outcomes of the optimisation process. Data were tabulated and summarised in a narrative format.ResultsWe screened 3968 titles and 231 abstracts for eligibility. Eighty-nine full-text papers were retrieved; 27 studies met our selection criteria. Optimisation strategies were used for a range of reasons: to explore the feasibility and acceptability of the intervention to patients and healthcare professionals; to estimate the effectiveness and cost-effectiveness of different combinations of intervention components; and to identify potential barriers to implementation. Methods varied widely across studies, from interviews and focus groups to economic modelling and probability analysis.ConclusionsThe review identifies a range of optimisation strategies currently used. Although a preliminary classification of these strategies can be proposed, a series of questions remain as to which methods to use for different interventions and how to determine when the intervention is ready or ‘optimised enough’ to be tested in a RCT. Future research should explore potential answers to the questions raised, to guide researchers in the development and evaluation of more effective interventions.
“…The largest effects were found on psychological distress (CORE-OM) and depression (PHQ9), with smaller effects on functioning (WSAS), health related quality of life (EQ5D) and minimal impacts on anxiety (GAD-7). The small numbers mean that these results are not statistically significant but the magnitude is fairly substantial compared to other psychosocial interventions in primary care [28]. These results are not adjusted for any potential baseline differences.Figure 5
Forest plot of effects of well being intervention on elders’ sample.…”
BackgroundPsychological therapy is effective for symptoms of mental distress, but many groups with high levels of mental distress face significant barriers in terms of access to care, as current interventions may not be sensitive to their needs or their understanding of mental health. There is a need to develop forms of psychological therapy that are acceptable to these groups, feasible to deliver in routine settings, and clinically and cost effective.MethodsWe developed a culturally sensitive wellbeing intervention with individual, group and sign-posting elements, and tested its feasibility and acceptability for patients from ethnic minorities and older people in an exploratory randomised trial.ResultsWe recruited 57 patients (57% of our target) from 4 disadvantaged localities in the NW of England. The results of the exploratory trial suggest that the group receiving the wellbeing interventions improved compared to the group receiving usual care. For elders, the largest effects were on CORE-OM and PHQ-9. For ethnic minority patients, the largest effect was on PHQ-9. Qualitative data suggested that patients found the intervention acceptable, both in terms of content and delivery.ConclusionsThis exploratory trial provides some evidence of the efficacy and acceptability of a wellbeing intervention for older and ethnic minority groups experiencing anxiety and depression, although challenges in recruitment and engagement remain. Evidence from our exploratory study of wellbeing interventions should inform new substantive trial designs.Trial registrationCurrent controlled trials ISRCTN68572159
“…Although other research groups have successfully synthesised quantitative and qualitative research evidence, 351 and incorporated consensus procedures to identify key interventions, 352 we are not aware of previous examples of research teams including stakeholder and service user perspectives within the intervention development stage in the integrated, synergistic manner achieved here. Our experiences may, therefore, be of interest to others planning innovative, research-based complex interventions in health care.…”
BackgroundEvidence-based interventions exist for common mental health problems. However, many people are unable to access effective care because it is not available to them or because interactions with caregivers do not address their needs. Current policy initiatives focus on supply-side factors, with less consideration of demand.Aim and objectivesOur aim was to increase equity of access to high-quality primary mental health care for underserved groups. Our objectives were to clarify the mental health needs of people from underserved groups; identify relevant evidence-based services and barriers to, and facilitators of, access to such services; develop and evaluate interventions that are acceptable to underserved groups; establish effective dissemination strategies; and begin to integrate effective and acceptable interventions into primary care.Methods and resultsExamination of evidence from seven sources brought forward a better understanding of dimensions of access, including how people from underserved groups formulate (mental) health problems and the factors limiting access to existing psychosocial interventions. This informed a multifaceted model with three elements to improve access: community engagement, primary care quality and tailored psychosocial interventions. Using a quasi-experimental design with a no-intervention comparator for each element, we tested the model in four disadvantaged localities, focusing on older people and minority ethnic populations. Community engagement involved information gathering, community champions and focus groups, and a community working group. There was strong engagement with third-sector organisations and variable engagement with health practitioners and commissioners. Outputs included innovative ways to improve health literacy. With regard to primary care, we offered an interactive training package to 8 of 16 practices, including knowledge transfer, systems review and active linking, and seven agreed to participate. Ethnographic observation identified complexity in the role of receptionists in negotiating access. Engagement was facilitated by prior knowledge, the presence of a practice champion and a sense of coproduction of the training. We developed a culturally sensitive well-being intervention with individual, group and signposting elements and tested its feasibility and acceptability for ethnic minority and older people in an exploratory randomised trial. We recruited 57 patients (57% of target) with high levels of unmet need, mainly through general practitioners (GPs). Although recruitment was problematic, qualitative data suggested that patients found the content and delivery of the intervention acceptable. Quantitative analysis suggested that patients in groups receiving the well-being intervention improved compared with the group receiving usual care. The combined effects of the model included enhanced awareness of the psychosocial intervention among community organisations and increased referral by GPs. Primary care practitioners valued community information gathering and access to the Improving Access to Mental Health in Primary Care (AMP) psychosocial intervention. We consequently initiated educational, policy and service developments, including a dedicated website.ConclusionsFurther research is needed to test the generalisability of our model. Mental health expertise exists in communities but needs to be nurtured. Primary care is one point of access to high-quality mental health care. Psychosocial interventions can be adapted to meet the needs of underserved groups. A multilevel intervention to increase access to high-quality mental health care in primary care can be greater than the sum of its parts.Study registrationCurrent Controlled Trials ISRCTN68572159.FundingThe National Institute for Health Research Programme Grants for Applied Research programme.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
