Feasibility and acceptability of web-based enhanced relapse prevention for bipolar disorder (ERPonline): trial protocol.

BACKGROUND Relapse prevention interventions for Bipolar Disorder are effective but implementation in routine clinical services is poor. Web-based approaches offer a way to offer easily accessible access to evidence based interventions at low cost, and have been shown to be effective for other mood disorders. METHODS/DESIGN This protocol describes the development and feasibility testing of the ERPonline web-based intervention using a single blind randomised controlled trial. Data will include the extent to which the site was used, detailed feedback from users about their experiences of the site, reported benefits and costs to mental health and wellbeing of users, and costs and savings to health services. We will gain an estimate of the likely effect size of ERPonline on a range of important outcomes including mood, functioning, quality of life and recovery. We will explore potential mechanisms of change, giving us a greater understanding of the underlying processes of change, and consequently how the site could be made more effective. We will be able to determine rates of recruitment and retention, and identify what factors could improve these rates. DISCUSSION The findings will be used to improve the site in accordance with user needs, and inform the design of a large scale evaluation of the clinical and cost effectiveness of ERPonline. They will further contribute to the growing evidence base for web-based interventions designed to support people with mental health problems.

[1]  Steven H. Jones,et al.  The bipolar recovery questionnaire: psychometric properties of a quantitative measure of recovery experiences in bipolar disorder. , 2013, Journal of affective disorders.

[2]  P R Williamson,et al.  Interventions for helping people recognise early signs of recurrence in bipolar disorder. , 2007, The Cochrane database of systematic reviews.

[3]  Gavin Andrews,et al.  Internet Treatment for Depression: A Randomized Controlled Trial Comparing Clinician vs. Technician Assistance , 2010, PloS one.

[4]  J. Krupnick An Automated Internet Application to Help Patients With Bipolar Disorder Track Social Rhythm Stabilization , 2013 .

[5]  M. Petticrew,et al.  Developing and evaluating complex interventions: the new Medical Research Council guidance , 2008, BMJ : British Medical Journal.

[6]  A. van Straten,et al.  Comparison of EQ-5D and SF-6D utilities in mental health patients. , 2006, Health economics.

[7]  W. Mansell,et al.  Extreme appraisals of internal states and bipolar symptoms: the Hypomanic Attitudes and Positive Predictions Inventory. , 2011, Psychological assessment.

[8]  G. Parker,et al.  The Ins and Outs of an Online Bipolar Education Program: A Study of Program Attrition , 2010, Journal of medical Internet research.

[9]  N. Titov,et al.  Clinician-Assisted Internet-Based Treatment is Effective for Panic: A Randomized Controlled Trial , 2009, The Australian and New Zealand journal of psychiatry.

[10]  N. Tarrier,et al.  Randomised controlled trial of efficacy of teaching patients with bipolar disorder to identify early symptoms of relapse and obtain treatment , 1999, BMJ.

[11]  R. Morriss,et al.  Involving relatives in relapse prevention for bipolar disorder: a multi-perspective qualitative study of value and barriers , 2011, BMC psychiatry.

[12]  P. Bech,et al.  The mania rating scale: Scale construction and inter-observer agreement , 1978, Neuropharmacology.

[13]  Steven H. Jones,et al.  Recovery-focused cognitive-behavioural therapy for recent-onset bipolar disorder: randomised controlled pilot trial. , 2015, The British journal of psychiatry : the journal of mental science.

[14]  J. McKay,et al.  Comparability of Telephone and In-Person Structured Clinical Interview for DSM-III-R (SCID) Diagnoses , 1999, Assessment.

[15]  Sarah M. Uzelac,et al.  Methodological considerations of measuring disability in bipolar disorder: validity of the Multidimensional Scale of Independent Functioning. , 2007, Bipolar disorders.

[16]  K. Cavanagh,et al.  The effectiveness of computerized cognitive behavioural therapy in routine care. , 2006, The British journal of clinical psychology.

[17]  R. Morriss,et al.  Early warning signs checklists for relapse in bipolar depression and mania: utility, reliability and validity. , 2011, Journal of affective disorders.

[18]  P. Czobor,et al.  The multidimensional scale of independent functioning: a new instrument for measuring functional disability in psychiatric populations. , 2003, Schizophrenia bulletin.

[19]  J. Mundt,et al.  The Work and Social Adjustment Scale: a simple measure of impairment in functioning. , 2002, The British journal of psychiatry : the journal of mental science.

[20]  T. Johnson,et al.  Measuring health-related quality of life in bipolar disorder: Relationship of the EuroQol (EQ-5D) to condition-specific measures , 2006, Quality of Life Research.

[21]  J. Savarino,et al.  An online recovery plan program: can peer coaching increase participation? , 2011, Psychiatric services.

[22]  H. Pincus,et al.  Clinical utility as a criterion for revising psychiatric diagnoses. , 2004, The American journal of psychiatry.

[23]  Steven H. Jones,et al.  A randomised controlled trial of recovery focused CBT for individuals with early bipolar disorder , 2012, BMC Psychiatry.

[24]  David J Miklowitz,et al.  Psychosocial intervention development for the prevention and treatment of depression: promoting innovation and increasing access , 2002, Biological Psychiatry.

[25]  G. Parker,et al.  Effects of adjunctive peer support on perceptions of illness control and understanding in an online psychoeducation program for bipolar disorder: a randomised controlled trial. , 2012, Journal of affective disorders.

[26]  R. Morriss,et al.  Enhanced relapse prevention for bipolar disorder – ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder , 2007, BMC psychiatry.

[27]  Steven H. Jones,et al.  What do service users with bipolar disorder want from a web-based self-management intervention? A qualitative focus group study. , 2013, Clinical psychology & psychotherapy.

[28]  G. Simon,et al.  Accuracy of recall for mania symptoms using a three month timeline follow-back interview. , 2008, Journal of affective disorders.

[29]  Gordon Parker,et al.  Next Generation of Self-Management Education: Web-based Bipolar Disorder Program , 2007, The Australian and New Zealand journal of psychiatry.

[30]  D. Rubin INFERENCE AND MISSING DATA , 1975 .

[31]  Jennifer Nicholas,et al.  Mechanisms underpinning effective peer support: a qualitative analysis of interactions between expert peers and patients newly-diagnosed with bipolar disorder , 2012, BMC Psychiatry.

[32]  P. Lewinsohn,et al.  Comparability of telephone and face-to-face interviews in assessing axis I and II disorders. , 1997, The American journal of psychiatry.

[33]  M. Hamilton A RATING SCALE FOR DEPRESSION , 1960, Journal of neurology, neurosurgery, and psychiatry.

[34]  Kate Cavanagh,et al.  Computer treatment for common mental health problems. , 2004, Journal of clinical psychology.

[35]  Martin Knapp,et al.  Cost-effectiveness of computerised cognitive-behavioural therapy for anxiety and depression in primary care: Randomised controlled trial , 2004, British Journal of Psychiatry.

[36]  G. Murray,et al.  Development of the QoL.BD: a disorder-specific scale to assess quality of life in bipolar disorder. , 2010, Bipolar disorders.

[37]  N. Titov,et al.  Clinician-Assisted Internet-Based Treatment is Effective for Depression: Randomized Controlled Trial , 2009, The Australian and New Zealand journal of psychiatry.

[38]  G. Murray,et al.  Development of an online intervention for bipolar disorder. www.moodswings.net.au , 2013, Psychology, health & medicine.

[39]  R. Morriss,et al.  The Role of Beliefs About Mood Swings in Determining Outcome in Bipolar Disorder , 2013, Cognitive Therapy and Research.

[40]  J. Proudfoot,et al.  The development and beta-test of a computer-therapy program for anxiety and depression: hurdles and lessons , 2003, Comput. Hum. Behav..

[41]  F. Goodwin,et al.  An automated Internet application to help patients with bipolar disorder track social rhythm stabilization. , 2011, Psychiatric services.

[42]  B. Everitt,et al.  Clinical efficacy of computerised cognitive-behavioural therapy for anxiety and depression in primary care: Randomised controlled trial , 2004, British Journal of Psychiatry.

[43]  N. Titov,et al.  Shyness 3: Randomized Controlled Trial of Guided Versus Unguided Internet-Based CBT for Social Phobia , 2008, The Australian and New Zealand journal of psychiatry.

[44]  P. Morosini,et al.  Development, reliability and acceptability of a new version of the DSM‐IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social funtioning , 2000, Acta psychiatrica Scandinavica.

[45]  Steven H. Jones,et al.  A web-based self-management intervention for Bipolar Disorder 'living with bipolar': a feasibility randomised controlled trial. , 2014, Journal of affective disorders.

[46]  Danny J. Smith,et al.  Internet-based psychoeducation for bipolar disorder: a qualitative analysis of feasibility, acceptability and impact , 2012, BMC Psychiatry.

[47]  A. Sergejew,et al.  Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses , 2000, Schizophrenia Research.

[48]  D. Lam,et al.  Prodromes, coping strategies and psychological interventions in bipolar disorders. , 2005, Clinical psychology review.

[49]  N. Andreasen,et al.  The Longitudinal Interval Follow-up Evaluation. A comprehensive method for assessing outcome in prospective longitudinal studies. , 1987, Archives of general psychiatry.

[50]  N. Craddock,et al.  Beating Bipolar: exploratory trial of a novel Internet-based psychoeducational treatment for bipolar disorder. , 2011, Bipolar disorders.

[51]  D. Kupfer,et al.  Functional impairment in the remission phase of bipolar disorder. , 2005, Bipolar disorders.

[52]  P. Mitchell,et al.  Evaluation of an Online Relapse Prevention Program for Bipolar Disorder , 2007 .

[53]  Steven H. Jones,et al.  An online randomised controlled trial to assess the feasibility, acceptability and potential effectiveness of 'Living with Bipolar': a web-based self-management intervention for bipolar disorder: trial design and protocol. , 2012, Contemporary clinical trials.

[54]  M. Knapp,et al.  Client Socio-Demographic and Service Receipt Inventory – European Version: development of an instrument for international research , 2000, British Journal of Psychiatry.

[55]  Susan Michie,et al.  Developing and Evaluating Complex Interventions , 2015 .