Trials | |
Low-intensity internet-delivered treatment for generalized anxiety symptoms in routine care: protocol for a randomized controlled trial | |
Ciara Joyce1  Amy Colla1  Chuck Rashleigh2  Orla McLoughlin2  John Sharry3  Gavin Doherty4  Ladislav Timulak5  Derek Richards5  | |
[1] SilverCloud Health, The Priory, John’s Street West, Dublin 8, Ireland;University of Dublin, Trinity College, Dublin 2, Ireland;Mater Misericordiae University Hospital, Eccles St., Dublin 7, Ireland;School of Computer Science & Statistics, University of Dublin, Trinity College, Dublin 2, Ireland;School of Psychology, University of Dublin, Trinity College, Dublin 2, Ireland | |
关键词: Randomized trial; CBT; Students; Treatment; Online interventions; Generalized anxiety disorder; | |
Others : 806667 DOI : 10.1186/1745-6215-15-145 |
|
received in 2013-12-05, accepted in 2014-04-14, 发布年份 2014 | |
【 摘 要 】
Background
Worldwide prevalence of generalized anxiety disorder (GAD) is considered high; in Europe lifetime prevalence has been estimated at 4.3 to 5.9%. High levels of anxiety disorders have been reported in university students, affecting 25 to 30% of the population. Young adults are some of the most vulnerable for the onset of mental health disorders and any stressors may act as a catalyst for their onset. The absence of resources can often mean that many do not seek treatment. Other factors that impede access to resources include such things as a lack of trained professionals, personal stigma, and waiting lists. Anxiety disorders can be treated successfully; indeed brief forms of cognitive-behavior therapy have been recommended. One potential avenue for research and development is that of delivering low-intensity interventions online for students with GAD. Therefore, the current study seeks to investigate the potential effectiveness for a low-intensity online CBT-based treatment for GAD in a service-based setting; implemented as one step in a stepped-care model.
Methods/Design
The research is a service-based effectiveness study utilizing a randomized waiting-list controlled design. The active intervention consists of six weekly modules of online CBT. Participants are assigned a supporter who provides weekly post-session feedback on progress and exercises. Participants will complete the GAD-7 as the primary outcome measure. Secondary outcomes include pathological worry, depression and measures of well-being. At three-months follow-up data will be collected using the GAD-7, BDI-II, PSWQ, ED-Q5 and WSAS. Post-session data will be collected on significant in-session events in treatment (HAT). A satisfaction with treatment measure will be administered post-treatment (SAT).
Discussion
The study will be a contribution to the potential for a low-intensity internet-delivered program implemented in a service-based setting; implemented as one step in a stepped-care model. The study will be a contribution to the already established work in online treatments for anxiety worldwide. The study will assess the utility of an innovative digital health solution (SilverCloud) to deliver such interventions.
Trial registration
Current Controlled Trials ISRCTN16303842.
【 授权许可】
2014 Richards et al.; licensee BioMed Central Ltd.
【 预 览 】
Files | Size | Format | View |
---|---|---|---|
20140708095213224.pdf | 365KB | download | |
Figure 1. | 56KB | Image | download |
【 图 表 】
Figure 1.
【 参考文献 】
- [1]Smit F, Cuijpers P, Oostenbrink J, Batelaan N, de Graaf R, Beekman A: Costs of nine common mental disorders: implications for curative and preventive psychiatry. J Ment Health Policy Econ 2006, 9:193-200.
- [2]American Psychiatric Association (APA): Diagnostic and statistical manual of mental disorders (DSM-5). 5th edition. Washington DC: American Psychiatric Association; 2013.
- [3]Alonso J, Angermeyer M, Bernert S, Bruffaerts R, Brugha T, Bryson H, De Girolamo G, De Graaf R, Demyttenaere K, Gasquet D: Prevalence of mental disorders in Europe: results from the European Study of the Epidemiology of Mental Disorders (ESEMeD) project. Acta Psychiatr Scand Suppl 2004, 109:21-27.
- [4]Alonso J, Angermeyer M, Bernert S, Bruffaerts R, Brugha T, Bryson H, De Girolamo G, De Graaf R, Demyttenaere K, Gasquet I: 12-Month comorbidity patterns and associated factors in Europe: results from the European Study of the Epidemiology of Mental Disorders (ESEMeD) project. Acta Psychiatr Scand Suppl 2004, 109:28-37.
- [5]Wittchen HU, Jacobi F, Rehm J, Gustavsson A, Svensson M, Jonsson B, Olesen J, Allgulander C, Alonso J, Faravelli C, Fratiglioni L, Jennum P, Lieb R, Maercker A, van Os J, Preisig M, Salvador-Carulla L, Simon R, Steinhausen HC: The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur Neuropsychopharmacol 2011, 21:655-679.
- [6]Tyrer P, Baldwin D: Generalised anxiety disorder. Lancet 2006, 368:2156-2166.
- [7]Wittchen HU: Met and unmet need for interventions in community cases with anxiety disorders. In Unmet Need in Psychiatry: Problems, Resources, Responses. Edited by Andrews G, Henderson S. Cambridge: Cambridge University Press; 2000:256-276.
- [8]Richards D: Prevalence and clinical course of depression: a review. Clin Psychol Rev 2011, 31:1117-1125.
- [9]Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE: Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry 2005, 62:593-602.
- [10]Kessler RC, Chiu W, Demler O, Walters EE: Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry 2005, 62:617-627.
- [11]Judd L, Kessler R, Paulus M, Zeller P, Wittchen H, Kunovac J: Comorbidity as a fundamental feature of generalized anxiety disorders: results from the National Comorbidity Study (NCS). Acta Psychiatr Scand Suppl 1998, 393:6-11.
- [12]Royal College of Psychiatrists: Mental health of students in higher education. London: Royal College of Psychiatrists; 2011:97.
- [13]McDonald AS: The prevalence and effects of test anxiety in school children. Educ Psychol 2001, 21:89-101.
- [14]Wachelka D, Katz RC: Reducing test anxiety and improving academic self-esteem in high school and college students with learning disabilities. J Behav Ther Exp Psychiatry 1999, 30:191-198.
- [15]Lovibond SH, Lovibond PF: Manual for the Depression Anxiety Stress Scales. 2nd edition. Sydney: Psychology Foundation; 1995.
- [16]Dooley B, Fitzgerald A: My world survey. Dublin: Headstrong; 2012.
- [17]Dyson R, Renk K: Freshmen adaptation to university life: depressive symptoms, stress, and coping. J Clin Psychol 2006, 62:1231-1244.
- [18]Royal College of Psychiatrists: The mental health of students in higher education. London: Royal College of Psychiatrists; 2003.
- [19]Andrews G, Creamer M, Crino R, Hunt C, Lampe L, Page A: The treatment of anxiety disorders: clinician guides and patient manuals. 2nd edition. Cambridge: Cambridge University Press; 2003.
- [20]Barlow DH, Allen LB, Choate ML: Toward a unified treatment for emotional disorders. Behav Ther 2004, 35:205-230.
- [21]Gould RA, Otto MW, Pollack MH, Yap L: Cognitive behavioral and pharmacological treatment of generalized anxiety disorder: a preliminary meta-analysis. Behav Ther 1997, 28:285-305.
- [22]Mitte K: Meta-analysis of cognitive-behavioral treatments for generalized anxiety disorder: a comparison with pharmacotherapy. Psychol Bull 2005, 131:785-795.
- [23]Borkovec TD, Ruscio AM: Psychotherapy for generalized anxiety disorder. J Clin Psychiatry 2001, 62:37-42.
- [24]Borkovec TD, Costello E: Efficacy of applied relaxation and cognitive-behavioral therapy in the treatment of generalized anxiety disorder. J Consult Clin Psychol 1993, 61:611-619.
- [25]Dugas MJ, Robichaud M: Cognitive-behavioral treatment for generalized anxiety disorder. New York: Routledge; 2007.
- [26]Behar E, DiMarco ID, Hekler EB, Mohlman J, Staples AM: Current theoretical models of generalized anxiety disorder (GAD): conceptual review and treatment implications. J Anxiety Disord 2009, 23:1011-1023.
- [27]Borkovec TD, Alcaine O, Behar E: Avoidance theory of worry and generalized anxiety disorder. In Generalized anxiety disorder: advances in research and practice. Edited by Heimberg RG, Turk CL, Mennin DS. New York: Guilford Press; 2004.
- [28]Dugas MJ, Gagnon F, Ladouceur R, Freeston MH: Generalized anxiety disorder: a preliminary test of a conceptual model. Behav Res Ther 1998, 36:215-226.
- [29]Andrews G, Sanderson K, Slade T, Issakidis C: Why does the burden of disease persist? relating the burden of anxiety and depression to effectiveness of treatment. In Bulletin World Health Organisation, Volume 78. Switzerland: World Health Organisation; 2000:446-454.
- [30]Wittchen HU, Jacobi F: Size and burden of mental disorders in Europe-a critical review and appraisal of 27 studies. Eur Neuropsychopharmacol 2005, 15:357-376.
- [31]Mowbray CT, Mandiberg JM, Stein CH, Kopels S, Curlin C, Megivern D, Strauss S, Collins K, Lett R: Campus mental health services: recommendations for change. Am J Orthopsychiatry 2006, 76:226-237.
- [32]Kohn R, Saxena S, Levav I, Saraceno B: The treatment gap in mental health care. Bull World Health Organ 2004, 82:858-866.
- [33]Titov N, Dear BF, Schwencke G, Andrews G, Johnston L, Craske MG, McEvoy P: Transdiagnostic internet treatment for anxiety and depression: a randomised controlled trial. Behav Res Ther 2011, 49:441-452.
- [34]National Institute for Clinical Excellence: Clinical guidelines 22: anxiety. London; 2004.
- [35]Bennett-Levy J, Richards DA, Farrand P, Christensen H, Griffiths KM, Kavanagh DJ, Klein B, Lau MA, Proudfoot J: Low intensity CBT interventions. In Oxford guide to low intensity CBT interventions. Edited by Bennett-Levy J, Richards DA, Farrand P, Christensen H, Griffiths KM, Kavanagh DJ, Klein B, Lau MA, Proudfoot J, Ritterband L, White J, Williams C. Oxford: Oxford University Press; 2010.
- [36]National Institute for Health and Clinical Excellence: Computerised cognitive behaviour therapy for depression and anxiety. Technology Appraisal 97. London: National Institute for Health and Clinical Excellence; 2006.
- [37]Clark DM, Layard R, Smithies R, Richards DA, Suckling R, Wright B: Improving access to psychological therapy: initial evaluation of two UK demonstration sites. Behav Res Ther 2009, 47:910-920.
- [38]Bennett-Levy J, Richards DA, Farrand P, Christensen H, Griffiths KM, Kavanagh DJ, Klein B, Lau MA, Proudfoot J: Low intensity CBT interventions: a revolution in mental healthcare. In Oxford guide to low intensity CBT interventions. Edited by Bennett-Levy J, Richards DA, Farrand P, Christensen H, Griffiths KM, Kavanagh DJ, Klein B, Lau MA, Proudfoot J, Ritterband L, White J, Williams C. Oxford: Oxford University Press; 2010:3-18.
- [39]Andrews G, Cuijpers P, Craske M, McEvoy P, Titov N: Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS One 2010, 5:e13196.
- [40]Cuijpers P, Marks I, van Straten A, Cavanagh K, Gega L, Andersson G: Computer-aided psychotherapy for anxiety disorders: a meta-analytic review. Cogn Behav Ther 2009, 38:66-82.
- [41]Reger M, Gahm G: A meta-analysis of the effects of Internet-and computer-based cognitive-behavioral treatments for anxiety. J Clin Psychol 2009, 65:53-75.
- [42]Richards D, Richardson T: Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev 2012, 32:329-342.
- [43]Andersson G: Using the internet to provide cognitive behaviour therapy. Behav Res Ther 2009, 47:175-180.
- [44]Carlbring P, Bohman S, Brunt S, Buhrman M, Westling B, Ekselius L, Andersson G: Remote treatment of panic disorder: a randomized trial of internet-based cognitive behavior therapy supplemented with telephone calls. Am J Psychiatry 2006, 163:2119-2125.
- [45]Furmark T, Carlbring P, Hedman E, Sonnenstein A, Clevberger P, Bohman B, Eriksson A, Hållén A, Frykman M, Holmström A, Sparthan E, Tillfors M, Ihrfelt E, Spak M, Eriksson A, Ekselius L, Andersson G: Guided and unguided self-help for social anxiety disorder: randomised controlled trial. Br J Psychiatry 2009, 195:440-447.
- [46]Lange A, Van den Ven JP, Schrieken B, Hudcovicova M, Rietdijk D, Hudcovicova M, EmmelKamp P: Interapy: a controlled randomized trail of the standard treatment of posttraumatic stress through the internet. J Consult Clin Psychol 2003, 71:901-909.
- [47]Titov N, Gibson M, Andrews G, McEvoy P: Internet treatment for social phobia reduces comorbidity. Aust N Z J Psychiatry 2009, 43:754-759.
- [48]Dear BF, Titov N, Schwencke G, Andrews G, Johnston L, Craske MG, McEvoy P: An open trial of a brief transdiagnostic internet treatment for anxiety and depression. Behav Res Ther 2011, 49:830-837.
- [49]Paxling B, Almlov J, Dahlin M, Carlbring P, Breitholtz E, Eriksson T, Andersson G: Guided Internet-delivered cognitive behavior therapy for generalized anxiety disorder: A randomized controlled trial. Cogn Behav Ther 2011, 40:159-173.
- [50]Robinson E, Titov N, Andrews G, McIntyre K, Schwencke G, Solley K: Internet treatment for generalized anxiety disorder: a randomized controlled trial comparing clinician vs technician assistance. PLoS One 2010, 5:e10942.
- [51]Titov N, Andrews G, Robinson E, Schwencke G, Johnston L, Solley K, Choi I: Clinician-assisted Internet-based treatment is effective for generalized anxiety disorder: randomised controlled trial. Aust N Z J Psychiatry 2009, 43:905-912.
- [52]Donegan E, Dugas MJ: Generalized anxiety disorder: a comparison of symptom change in adults receiving cognitive-behavioral therapy or applied relaxation. J Consult Clin Psychol 2012, 80:490-496.
- [53]Gallagher S, Tedstone-Doherty D, Moran R, Kartalova-Doherty Y: Internet use and seeking health information online in Ireland: demographic characteristics and mental health characteristics of users and non-users. Dublin: Health Research Board; 2008:1-57.
- [54]Newman MG, Szkodny LE, Llera SJ, Przeworski A: A review of technology-assisted self-help and minimal contact therapies for anxiety and depression: Is human contact necessary for therapeutic efficacy? Clin Psychol Rev 2011, 31:89-103.
- [55]Internet users in Europe: Internet users in Europe. [http://www.internetworldstats.com/stats4.htm#europe webcite]
- [56]Cavanagh K, Seccombe N, Lidbetter N: The implementation of computerized cognitive behavioural therapies in a service user-led, third sector self-help clinic. Behav Cogn Psychother 2011, 39:427-442.
- [57]Cavanagh K, Shapiro DA, Van Den Berg S, Swain S, Barkham M, Proudfoot J: The effectiveness of computerized cognitive behavioural therapy in routine care. Br J Clin Psychol 2006, 45:499-514.
- [58]Ruwaard J, Lange A, Schrieken B, Dolan CV, Emmelkamp P: The effectiveness of online cognitive behavioral treatment in routine clinical practice. PLoS One 2012, 7:e40089.
- [59]Sharry J, Davidson R, McLoughlin O, Doherty G: A service-based evaluation of a therapist-supported online cognitive behavioural therapy programme for depression. J Med Internet Res 2013, 15:e121.
- [60]Eysenbach G: The law of attrition. J Med Internet Res 2005, 7:e11.
- [61]Richards D, Timulak L, Hevey D: A comparison of two online cognitive-behavioural interventions for symptoms of depression in a student population: The role of therapist responsiveness. Couns Psychother Res 2013, 3:184-193.
- [62]Warmerdam L, van Straten A, Twisk J, Riper H, Cuijpers P: Internet-based treatment for adults with depressive symptoms: randomized controlled trial. J Med Internet Res 2008, 10:e44.
- [63]Almlöv J, Carlbring P, Berger T, Cuijpers P, Andersson G: Therapist factors in Internet-delivered cognitive behavioural therapy for major depressive disorder. Cogn Behav Ther 2009, 38:247-254.
- [64]Palmqvist B, Carlbring P, Andersson G: Internet-delivered treatments with or without therapist input: does the therapist factor have implications for efficacy and cost? Expert Rev Pharmacoecon Outcomes Res 2007, 7:291-297.
- [65]Richards D, Richardson T, Timulak L, McElvaney J: The efficacy of online-delivered treatment for Generalized Anxiety Disorder: a systematic review and meta-analysis. J Anxiety Disordin press
- [66]Meyer T, Miller M, Metzger R, Borkovec T: Development and validation of the Penn State Worry Questionnaire. Behav Res Ther 1990, 28:487-495.
- [67]Spitzer RL, Kroenke K, Williams JW, Löwe B: A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med 2006, 166:1092-1097.
- [68]Kroenke K, Spitzer RL, Williams JBW, Löwe B: The patient health questionnaire somatic, anxiety, and depressive symptom scales: a systematic review. Gen Hosp Psychiatry 2010, 32:345-359.
- [69]Löwe B, Decker O, Müller S, Brähler E, Schellberg D, Herzog W, Herzberg PY: Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care 2008, 46:266-274.
- [70]Richards DA, Suckling R: Improving access to psychological therapies: phase IV prospective cohort study. Br J Clin Psychol 2009, 48:377-396.
- [71]Molina S, Borkovec TD: The Penn State Worry Questionnaire: psychometric properties and associated characteristics. In Worrying: perspectives on theory, assessment and treatment. Edited by Davey G, Tallis F. New York: Wiley; 1994:265-283.
- [72]Brown TA, Antony MM, Barlow DH: Psychometric properties of the Penn state worry questionnaire in a clinical anxiety disorders sample. Behav Res Ther 1992, 30:33-37.
- [73]Beck AT, Steer RA, Brown GK: Manual for the BDI-II. San Antonio: Psychological Corporation; 1996.
- [74]American Psychiatric Association (APA): Diagnostic and statistical manual of mental disorders (DSM-IV-TR). 4th edition. Washington DC: American Psychiatric Association; 2000.
- [75]Arnau RC, Meagher MW, Norris MP, Bramson R: Psychometric evaluation of the Beck Depression Inventory-II with primary care medical patients. Health Psychol 2001, 20:112-119.
- [76]Steer RA, Rissmiller DJ, Beck AT: Use of the Beck Depression Inventory-II with depressed geriatric inpatients. Behav Res Ther 2000, 38:311-318.
- [77]Beck AT, Steer RA, Garbin MG: Psychometric properties of the Beck Depression Inventory: twenty-five years of evaluation. Clin Psychol Rev 1988, 8:77-100.
- [78]Rabin R, Oemar M, Oppe M: EQ-5D-3 L User Guide: basic information on how to use the EQ-5D-3 L instrument. 40th edition. Rotterdam: EuroQol Group; 2011.
- [79]Mundt JC, Marks IM, Shear MK, Greist JM: The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry 2002, 180:461-464.
- [80]Elliott R, Slatick E, Urman M: Qualitative change process research on psychotherapy: alternative strategies. In Qualitative psychotherapy research: methods and methodology. Edited by Frommer J, Rennie DL. Lengerich: Pabst Science Publishers; 2001:69-111.
- [81]Llewelyn SP, Elliott R, Shapiro DA, Hardy G, Firth-Cozens J: Client perceptions of significant events in prescriptive and exploratory periods of individual therapy. Br J Clin Psychol 1988, 27:105-114.
- [82]Richards D, Timulak L: Satisfaction with therapist-delivered vs. self-administered online cognitive-behavioural treatments for depression symptoms in college students. Br J Guid Couns 2012, 41:193-207.
- [83]Cohen J: Statistical power analysis for the behavioral sciences. 2nd edition. Hillsdale: Lawrence Earlbaum Associates; 1988.
- [84]Radloff L: The CES-D Scale: a self-report depression scale for research in a general population. Appl Psychol Meas 1977, 1:385-401.
- [85]Behar E, Alcaine O, Zuellig AR, Borkovec TD: Screening for generalized anxiety disorder using the Penn State Worry Questionnaire: a receiver operating characteristic analysis. J Behav Ther Exp Psychiatry 2003, 34:25-43.
- [86]Jacobson NS, Truax P: Clinical significance: A statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol 1991, 59:12-19.
- [87]Elliott R, Timulak L: Descriptive and interpretative approaches to qualitative research. In A handbook of research methods in clinical and health psychology. Edited by Miles J, Gilbert P. Oxford: Oxford University Press; 2005:147-160.
- [88]Richards D, Timulak L: Client-identified helpful and hindering events in therapist-delivered vs. self-administered online cognitive-behavioural treatments for depression in college students. Couns Psychol Q 2012, 25:251-262.