Title: Understanding and preventing Adverse Effects of Psychological Therapies?(AdEPT)
Funder: Department of Health (England)

Abstract: Background Based on research evidence of effectiveness, the NHS has from 2008 invested £170m recurrently to improve access to psychological therapies. Although group comparisons show therapy is effective, between 5-8% of people deteriorate during or after psychological therapy. In pharmacology, it has long been accepted that all effective medication has some toxicity and risk, but in the field of psychological therapies there is a widespread misapprehension that these treatments are at worst, harmless. The potential of psychological therapies to harm people is a topic notably absent from professional manuals, textbooks and research trials, which do not typically report on adverse effects or deterioration rates. In contrast, many user-led resources (internet sites, books) report this phenomenon. Aims a) To publish a systematic review of what is currently known about the potential adverse effects of psychological therapies and what can be done to minimise harm, b) To take the field forward by better estimation of potential for harm, through meta-analysis of primary data on deterioration rates in routine practice and in randomised controlled trials c) To understand the experience of service users and therapists who have experienced failed therapies, through a new mixed-method investigation exploring what they would have found helpful in preventing the adverse outcome; d) Based on all these sources of evidence, to develop and test support tools for service users, therapists and service managers. Plan of Investigation 1. A systematic review of scientific literature and service user accounts. 2. Multivariate analysis of deterioration rates in two national NHS outcomes datasets. 3. PIs of research trials in three key fields of mental health will be contacted for permission to include data from their studies in a meta-reanalysis of deterioration rates in active vs. control arms 4. Clients and therapists from failed psychological therapies will be identified by survey and a purposive sample interviewed for qualitative analysis. 5. Support tools will be developed using structured consensus methods involving panels of service users, practitioners and managers then tested in an NHS Trust and amongst service-users, as appropriate, for proof-of-concept. Potential Impact An early publication will alert the NHS to these issues and on the basis of existing knowledge, say what should be done to minimise avoidable adverse effects. The new study will yield at least three support tools: 1) a standardised report format for adverse events and deterioration rates designed for ease of NHS use in improved clinical governance, available to patients; 2) a decision support tool to inform and empower service users in failing therapies & 3) a simple-to-use case tracking method for practitioners plus clinical support tools. These tools are designed to protect patients from harm resulting from starting therapy without informed consent, being disempowered from leaving a failed therapy, lack of clinical governance oversight of poor outcomes or therapists’ lack of competence.


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: MENTAL HEALTH