Computerised therapy for depression with clinician vs. assistant and brief vs. extended phone support: study protocol for a randomised controlled trial

Trials

Jo Molle³  Jon Wilson³  Amanda Howe²  Richard Holland¹  Kelly Bird³  Nesta Reeve³  Gillian Todd³  Garry Barton¹  Louise Swift¹  Lina Gega¹ 

[1] Norwich Medical School, University of East Anglia, Norwich NR4 7TJ, UK;NHS Norfolk, Lakeside 400, Old Chapel Way, Broadland Business Park, Norwich NR7 OWG, UK;Norfolk & Suffolk NHS Foundation Trust (NSFT), Hellesdon Hospital, Norwich NR6 5BE, UK

关键词: Guided self-help;    Internet;    Cognitive behaviour therapy;   

Others  :  1095376
DOI  :  10.1186/1745-6215-13-151

 received in 2012-05-04, accepted in 2012-07-31,  发布年份 2012

【 摘 要 】

Background

Computerised cognitive behaviour therapy (cCBT) involves standardised, automated, interactive self-help programmes delivered via a computer. Randomised controlled trials (RCTs) and observational studies have shown than cCBT reduces depressive symptoms as much as face-to-face therapy and more than waiting lists or treatment as usual. cCBT’s efficacy and acceptability may be influenced by the “human” support offered as an adjunct to it, which can vary in duration and can be offered by people with different levels of training and expertise.

Methods/design

This is a two-by-two factorial RCT investigating the effectiveness, cost-effectiveness and acceptability of cCBT supplemented with 12 weekly phone support sessions are either brief (5–10 min) or extended (20–30 min) and are offered by either an expert clinician or an assistant with no clinical training. Adults with non-suicidal depression in primary care can self-refer into the study by completing and posting to the research team a standardised questionnaire. Following an assessment interview, eligible referrals have access to an 8-session cCBT programme called Beating the Blues and are randomised to one of four types of support: brief-assistant, extended-assistant, brief-clinician or extended-clinician.

A sample size of 35 per group (total 140) is sufficient to detect a moderate effect size with 90% power on our primary outcome measure (Work and Social Adjustment Scale); assuming a 30% attrition rate, 200 patients will be randomised. Secondary outcome measures include the Beck Depression and Anxiety Inventories and the PHQ-9 and GAD-7. Data on clinical outcomes, treatment usage and patient experiences are collected in three ways: by post via self-report questionnaires at week 0 (randomisation) and at weeks 12 and 24 post-randomisation; electronically by the cCBT system every time patients log-in; by phone during assessments, support sessions and exit interviews.

Discussion

The study’s factorial design increases its efficiency by allowing the concurrent investigation of two types of adjunct support for cCBT with a single sample of participants. Difficulties in recruitment, uptake and retention of participants are anticipated because of the nature of the targeted clinical problem (depression impairs motivation) and of the studied interventions (lack of face-to-face contact because referrals, assessments, interventions and data collection are completed by phone, computer or post).

Trial registration

Current Controlled Trials ISRCTN98677176

【 授权许可】

   
2012 Gega et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]World Health Ogranisation (WHO): The global burden of disease. WHO, Geneva; 2008.
• [2]Department of Health (DH): Treatment Choice in Psychological Therapies and Counselling: Evidence Based Clinical Practice Guideline. DH, London; 2001.
• [3]National Institute for Health & Clinical Excellence (NICE): Computerised cognitive behavioural therapy (CCBT) for the treatment of depression and anxiety: Technology Appraisal No. 97. NICE, London; 2006.
• [4]Foroushani PS, Schneider J, Assareh N: Meta-review of the effectiveness of computerised CBT in treating depression. BMC Psychiatry 2011, 11:131. BioMed Central Full Text
• [5]Clarke G, Eubanks D, Reid E, Kelleher C, O'Connor E, DeBar LL, Lynch F, Nunley S, Gullion C: Overcoming depression on the internet (ODIN) (2): A randomized trial of a self-help depression skills program with reminders. J Med Internet Res 2005, 7(2):e16.
• [6]Proudfoot J, Ryden C, Everitt B, Shapiro D, Goldberg D, Mann A, Tylee A, Marks I, Gray J: Clinical effectiveness of computerized cognitive behavioural therapy for anxiety and depression in primary care. Br J Psychiatry 2004, 185:46-54.
• [7]Berger T, Hämmerli K, Gubser N, Andersson G, Caspar F: Internet-based treatment of depression: a randomized controlled trial comparing guided with unguided self-help. Cogn Behav Ther 2011, 40:251-266.
• [8]Warmerdam L, van Straten A, Jongsma J, Twisk J, Cuijpers P: Online cognitive behavioral therapy and problem-solving therapy for depressive symptoms: Exploring mechanisms of change. J Behav Ther Exp Psychiatry 2010, 41:64-70.
• [9]Wright JH, Wright AS, Albano AM, Basco MR, Raffield T, Otto MW: Computer-assisted cognitive therapy for depression: Maintaining efficacy while reducing therapist time. Am J Psychiatry 2005, 162:1158-1164.
• [10]Cuijpers P, Donker T, van Straten A, Li J, Andersson G: Is guided self-help as effective as face-to-face psychotherapy for depression and anxiety disorders? A systematic review and meta-analysis of comparative outcome studies. Psychol Med 2010, 40:1943-1957.
• [11]Kaltenthaler E, Sutcliffe P, Parry G, Beverley C, Rees A, Ferriter M: The acceptability to patients of computerized cognitive behaviour therapy for depression: a systematic review. Psychol Med 2008, 38:1521-1530.
• [12]Cavanagh K, Shapiro DA, Van Den Berg S, Swain S, Barkham M, Proudfoot J: The acceptability of computer-aided cognitive behavioural therapy: a pragmatic study. Cogn Behav Ther 2009, 38:235-246.
• [13]Waller R, Gilbody S: Barriers to the uptake of computerized cognitive behavioural therapy: a systematic review of the quantitative and qualitative evidence. Psychol Med 2009, 39:705-712.
• [14]de Graaf LE, Huibers MJH, Riper H, Gerhards SAH, Arntz A: Use and acceptability of unsupported online computerized cognitive behavioral therapy for depression and associations with clinical outcome. J Affect Disord 2009, 116:227-231.
• [15]Eysenbach G: The law of attrition. J Med Internet Res 2005, 7:e11.
• [16]Chiu TML, Eysenbach G: Stages of use: consideration, initiation, utilization, and outcomes of an internet-mediated intervention. BMC Med Inform Decis Mak 2010, 10:73. BioMed Central Full Text
• [17]Christensen H, Griffiths KM, Farrer L: Adherence in Internet interventions for anxiety and depression: systematic review. J Med Internet Res 2009, 11:e13.
• [18]Marks IM, Kavanagh K, Gega L: Hands-on Help: Computer-aided Psychotherapy. Maudsely Monograph – No. 49. Psychology Press, Hove; 2007.
• [19]Spek V, Cuijpers P, Nyklícek I, Riper H, Keyzer J, Pop V: Internet-based cognitive behaviour therapy for symptoms of depression and anxiety: a meta-analysis. Psychol Med 2007, 37:319-328.
• [20]Palmqvist B, Carlbring P, Andersson G: Internet-delivered treatments with or without therapist input: does the therapist factor have implications for efficacy and cost? Exp Rev Pharmacoeconom Outcomes Res 2007, 7:291-297.
• [21]Titov N, Andrews G, Choi I, Schwencke G, Mahoney A: Shyness 3: randomized controlled trial of guided versus unguided Internet-based CBT for social phobia. Aust NZ J Psychiatry 2008, 42:1030-1040.
• [22]Furmark T, Carlbring P, Hedman E, Sonnenstein A, Clevberger P, Bohman B, Eriksson A, Hållén A, Frykman M, Holmström A, Sparthan E, Tillfors M, Nilsson 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.
• [23]Palmer RL, Birchall H, Mcgrain L, Sullivan V: Self-help for bulimic disorders: a randomised controlled trial comparing minimal guidance with face-to-face or telephone guidance. Br J Psychiatry 2002, 181:230-235.
• [24]Schmidt U, Landau S, Pombo-Carril MG, Bara-Carril N, Reid Y, Murray K, Treasure J, Katzman M: Does personalized feedback improve the outcome of cognitive-behavioural guided self-care in bulimia nervosa? A preliminary randomized controlled trial. Br J Clin Psychol 2006, 45:111-121.
• [25]Murray K, Schmidt U, Pombo-Carril M-G, Grover M, Alenya J, Treasure J, Williams C: Does therapist guidance improve uptake, adherence and outcome from a CD-ROM based cognitive-behavioral intervention for the treatment of bulimia nervosa? Comput Hum Behav 2007, 23:850-859.
• [26]Farrer L, Christensen H, Griffiths KM, Mackinnon A: Internet-Based CBT for depression with and without telephone tracking in a national helpline: randomised controlled trial. PLoS One 2011, 6:e28099.
• [27]Klein B, Austin D, Pier C, Kiropoulos L, Shandley K, Mitchell J, Gilson K, Ciechomski L: Internet-based treatment for panic disorder: does frequency of therapist contact make a difference? Cogn Behav Ther 2009, 38:100-113.
• [28]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.
• [29]Titov N, Andrews G, Davies M, McIntyre K, Robinson E, Solley K: Internet treatment for depression: a randomized controlled trial comparing clinician vs. technician assistance. PLoS One 2010, 5:e10939.
• [30]World Health Ogranisation (WHO): International Classification of Diseases and Related Health Problems - 10th Revision (ICD-10). WHO, Geneva; 1992.
• [31]Schulz KF, Altman DG, Moher D, the CONSORT Group: CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials 2010, 11:32. BioMed Central Full Text
• [32]Department of Health (DH): Improving access to psychological therapies (IAPT) programme: computerised cognitive behavioural therapy (CCBT) implementation guidance. DH, London; 2007.
• [33]Gega L, Kenwright M, Mataix-Cols D, Cameron R, Marks IM: Screening people with anxiety/depression for suitability for guided self-help. Cogn Behav Ther 2005, 34:16-21.
• [34]Marks IM, Mathews AM: Brief standard self-rating for phobic patients. Behav Res Ther 1979, 23:563-569.
• [35]Mundt JC, Marks IM, Greist JH, Shear K: Work and Social Adjustment Scale: A simple accurate measure of impairment in functioning. Br J Psychiatry 2002, 180:461-464.
• [36]National IAPT Team: The IAPT Data Handbook: Guidance on recording and monitoring outcomes to support local evidence-based practice. 2011. http://www.iapt.nhs.uk/silo/files/the-iapt-data-handbook.pdf webcite] (accessed 03/02/2012
• [37]Department of Health (DH): Improving Access to Psychological Therapies (IAPT) Outcomes Toolkit. 2008/9. http://www.iapt.nhs.uk/2009/03/improving-access-to-psychological-therapies-key-performance-indicators-and technical-guidance-2009 webcite
• [38]Beck AT, Steer RA, Brown GK: Manual for the Beck Depression Inventory-II. Psychological Corporation, San Antonio, TX; 1996.
• [39]Beck AT, Epstein N, Brown G, Steer RA: An inventory for measuring clinical anxiety: Psychometric properties. J Consult Clin Psychol 1988, 56:893-897.
• [40]Brooks R: EuroQol: the current state of play. Health Policy 1996, 37:53-72.
• [41]National Institute of Health and Clinical Excellence (NICE): Guide to the Methods of Technology Appraisal. NICE, London; 2008.
• [42]Kroenke K, Spitzer RL, Williams JBW: The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 2001, 16:606-613.
• [43]Spitzer RL, Kroenke K, Williams JB, Löwe B: A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med 2006, 166:1092-1097.
• [44]Clark DM: Implementing NICE guidelines for the psychological treatment of depression and anxiety disorders: The IAPT experience. Int Rev Psychiatry 2011, 23:375-384.
• [45]Richards DA, Suckling R: Improving access to psychological therapies: Phase IV prospective cohort study. Br J Clin Psychol 2009, 48:377-396.
• [46]Agnew-Davies R, Stiles WB, Hardy GE, Barkham M, Shapiro DA: Alliance structure assessed by the Agnew Relationship Measure (ARM). Br J Clin Psychol 1998, 37:155-172.
• [47]Horvath AO, Greenberg LS: Development and validation of the Working Alliance Inventory. J Couns Psychol 1989, 36:223-233.
• [48]Marks IM, Mataix-Cols D, Kenwright M, Cameron R, Hirsch S, Gega L: Pragmatic evaluation of computer-aided self-help for anxiety and depression. Br J Psychiatry 2003, 183:57-65.
• [49]Cohen J: Statistical power analysis for the behavioral sciences. 2nd edition. Laurence Erlbaum, Hillsdale, NJ; 1988.
• [50]Jacobson NS, Truax P: Clinical significance: A statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol 1991, 59:12-19.
• [51]Altman DG: Missing outcomes in randomized trials: addressing the dilemma. Open Medicine 2009, 3:e51-e53.
• [52]Braun V, Clarke V: Using thematic analysis in psychology. Qual Res Psychol 2006, 3:77-101.
• [53]Curtis L, Netten A: Unit costs of health and social care. University of Kent, PSSRU; 2006.
• [54]Barton GR, Briggs A, Fenwick E: Optimal cost-effectiveness decisions: the role of the Cost-Effectiveness Acceptability Curve (CEAC), the Cost-Effectiveness Acceptability Frontier (CEAF), and the Expected Value of Perfection Information (EVPI). Value in Health 2008, 11:886-897.
• [55]Melville KM, Casey LM, Kavanagh DJ: Dropout from Internet-based treatment for psychological disorders. Br J Clin Psychol 2010, 49:455-471.
• [56]Lange A, Rietdijk D, Hudcovicova M, van den Ven J-P, Schrieken B, Emmelkamp PMG: Interapy: RCT of the standardized treatment of posttraumatic stress through the internet. J Consult Clin Psychol 2003, 71:901-909.
• [57]Lovell K, Cox D, Haddock G, Jones C, Raines D, Garvey R, Roberts C, Hadley S: Telephone administered cognitive behaviour therapy for treatment of obsessive compulsive disorder: randomised controlled non-inferiority trial. BMJ 2006, 333:883.
• [58]Burgess M, Andiappan M, Chalder T: Cognitive behaviour therapy for chronic fatigue syndrome in adults: face to face versus telephone treatment. a randomized controlled trial. Behav Cogn Psychother 2012, 40(2):175-191.