Implementing multifactorial psychotherapy research in online virtual environments (IMPROVE-2): study protocol for a phase III trial of the MOST randomized component selection method for internet cognitive-behavioural therapy for depression

Abstract

BackgroundDepression is a global health challenge. Although there are effective psychological and pharmaceutical interventions, our best treatments achieve remission rates less than 1/3 and limited sustained recovery. Underpinning this efficacy gap is limited understanding of how complex psychological interventions for depression work. Recent reviews have argued that the active ingredients of therapy need to be identified so that therapy can be made briefer, more potent, and to improve scalability. This in turn requires the use of rigorous study designs that test the presence or absence of individual therapeutic elements, rather than standard comparative randomised controlled trials. One such approach is the Multiphase Optimization Strategy, which uses efficient experimentation such as factorial designs to identify active factors in complex interventions. This approach has been successfully applied to behavioural health but not yet to mental health interventions.Methods/DesignA Phase III randomised, single-blind balanced fractional factorial trial, based in England and conducted on the internet, randomized at the level of the patient, will investigate the active ingredients of internet cognitive-behavioural therapy (CBT) for depression. Adults with depression (operationalized as PHQ-9 score ≥ 10), recruited directly from the internet and from an UK National Health Service Improving Access to Psychological Therapies service, will be randomized across seven experimental factors, each reflecting the presence versus absence of specific treatment components (activity scheduling, functional analysis, thought challenging, relaxation, concreteness training, absorption, self-compassion training) using a 32-condition balanced fractional factorial design (2IV 7-2). The primary outcome is symptoms of depression (PHQ-9) at 12 weeks. Secondary outcomes include symptoms of anxiety and process measures related to hypothesized mechanisms.DiscussionBetter understanding of the active ingredients of efficacious therapies, such as CBT, is necessary in order to improve and further disseminate these interventions. This study is the first application of a component selection experiment to psychological interventions in depression and will enable us to determine the main effect of each treatment component and its relative efficacy, and cast light on underlying mechanisms, so that we can systematically enhance internet CBT.Trial registrationCurrent Controlled Trials ISRCTN24117387. Registered 26 August 2014Electronic supplementary materialThe online version of this article (doi:10.1186/s12888-016-1054-8) contains supplementary material, which is available to authorized users.

A review of popular smartphone apps for depression and anxiety: Assessing the inclusion of evidence-based content

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Internet‐delivered psychological treatments: from innovation to implementation

“…There are various versions of factorial designs, and several such studies are in progress. The use of factorial designs is likely to speed up the development of new interventions and treatment components.…”

“…A fourth development has to do with research designs and publication bias. With regards to research designs, we believe that the standard treatment versus control design may be less needed as compared to more sophisticated factorial designs testing several research questions simultaneously. Publication bias is a problem in both basic and applied research, but we believe that change will happen.…”

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“…From a researcher's perspective, technology could facilitate doing studies in a more efficient and specific manner with interesting possibilities up ahead, e.g. regarding component analysis in psychotherapy (Watkins et al, 2016). Sweden has been a major contributor to this area of research and in a recent overview on internet-based cognitive behaviour therapy (ICBT) for anxiety, all but five of 37 included studies were conducted by research groups in Sweden and Australia (Mewton, Smith, Rossouw, & Andrews, 2014 …”