Protocol for a randomised controlled trial investigating the effectiveness of an online e-health application compared to attention placebo or sertraline in the treatment of generalised anxiety disorder

Trials

Volumn 11, Issue , 2010, Pages

  Christensen, Helen ^a   Guastella, Adam J ^b   Mackinnon, Andrew J ^c   Griffiths, Kathleen M ^a   Eagleson, Claire ^b   Batterham, Philip J ^a   Kalia, Kanupriya ^a   Kenardy, Justin ^d   Bennett, Kylie ^a   Hickie, Ian B ^b  

^a AUSTRALIAN NATIONAL UNIVERSITY   (Australia)

^b UNIVERSITY OF SYDNEY   (Australia)

^c UNIVERSITY OF MELBOURNE   (Australia)

^d UNIVERSITY OF QUEENSLAND   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

SERTRALINE; ANXIOLYTIC AGENT;

ARTICLE; CLINICAL EFFECTIVENESS; CLINICAL PROTOCOL; CLINICAL RESEARCH; COMPUTER ASSISTED THERAPY; COMPUTER PROGRAM; GENERALIZED ANXIETY DISORDER; INTERVENTION STUDY; ONLINE SYSTEM; PSYCHOTHERAPY; ADOLESCENT; ADULT; ANXIETY DISORDER; AUSTRALIA; CLINICAL TRIAL; COGNITIVE THERAPY; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; HUMAN; INTERNET; MALE; METHODOLOGY; PLACEBO EFFECT; PSYCHOLOGICAL ASPECT; RANDOMIZED CONTROLLED TRIAL; TIME; TREATMENT OUTCOME;

ADOLESCENT; ADULT; ANTI-ANXIETY AGENTS; ANXIETY DISORDERS; AUSTRALIA; COGNITIVE THERAPY; FEMALE; HUMANS; INTERNET; MALE; PLACEBO EFFECT; RESEARCH DESIGN; SERTRALINE; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 77953939868     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-11-48     Document Type: Article

References (60)

1. American Psychiatric Association Diagnostic and statistical manual of mental disorders: DSM-IV 1994, Washington, DC: American Psychiatric Association, 4, American Psychiatric Association.
2. Judd LL, Kessler RC, Paulus MP, Zeller PV, Wittchen HU, Kunovac JL. Comorbidity as a fundamental feature of generalized anxiety disorders: results from the National Comorbidity Study (NCS). Acta Psychiatr Scand Suppl 1998, 393:6-11. 10.1111/j.1600-0447.1998.tb05960.x, 9777041.
3. Tyrer P, Baldwin D. Generalised anxiety disorder. Lancet 2006, 368:2156-2166. 10.1016/S0140-6736(06)69865-6, 17174708.
4. Wittchen H. Met and unmet need for interventions in community cases with anxiety disorders. Unmet Need in Psychiatry 2000, 256-276. Cambridge: Cambridge University Press, Andrews G, Henderson S..
5. Feldner MT, Zvolensky MJ, Schmidt NB. Prevention of anxiety psychopathology: a critical review of the empirical literature. Clinical Psychology: Science and Practice 2004, 11:405-424.
6. Greenberg PE, Sisitsky T, Kessler RC, Finkelstein SN, Berndt ER, Davidson JR, Ballenger JC, Fyer AJ. The economic burden of anxiety disorders in the 1990s. J Clin Psychiatry 1999, 60:427-435.
7. Henderson M, Glozier N, Holland Elliott K. Long term sickness absence. BMJ 2005, 330:802-803. 10.1136/bmj.330.7495.802, 556060, 15817531.
8. Kessler RC, Greenberg PE, Mickelson KD, Meneades LM, Wang PS. The effects of chronic medical conditions on work loss and work cutback. J Occup Environ Med 2001, 43:218-225. 10.1097/00043764-200103000-00009, 11285869.
9. Mitte K. Meta-analysis of cognitive-behavioral treatments for generalized anxiety disorder: a comparison with pharmacotherapy. Psychol Bull 2005, 131:785-795. 10.1037/0033-2909.131.5.785, 16187860.
10. Gould RA, Safren SA, Washington DO, Otto MW. A meta-analytic review of cognitive-behavioral treatments. Generalized Anxiety Disorder: Advances in Research and Practice 2004, New York: Guilford Press, Heimberg RG, Turk CA, Mennin DS.
11. Borkovec TD, Ruscio AM. Psychotherapy for generalized anxiety disorder. J Clin Psychiatry 2001, 62(Suppl 11):37-42. discussion 43-35.
12. Baldwin DS, Polkinghorn C. Evidence-based pharmacotherapy of Generalized Anxiety Disorder. Int J Neuropsychopharmacol 2005, 8:293-302. 10.1017/S1461145704004870, 15576000.
13. Allgulander C, Dahl AA, Austin C, Morris PL, Sogaard JA, Fayyad R, Kutcher SP, Clary CM. Efficacy of sertraline in a 12-week trial for generalized anxiety disorder. Am J Psychiatry 2004, 161:1642-1649. 10.1176/appi.ajp.161.9.1642, 15337655.
14. Brawman-Mintzer O, Knapp RG, Rynn M, Carter RE, Rickels K. Sertraline treatment for generalized anxiety disorder: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry 2006, 67:874-881. 10.4088/JCP.v67n0603, 16848646.
15. Walkup JT, Albano AM, Piacentini J, Birmaher B, Compton SN, Sherrill JT, Ginsburg GS, Rynn MA, McCracken J, Waslick B, Iyengar S, March JS, Kendall PC. Cognitive behavioral therapy, sertraline, or a combination in childhood anxiety. N Engl J Med 2008, 359:2753-2766. 10.1056/NEJMoa0804633, 2702984, 18974308.
16. Rynn MA, Siqueland L, Rickels K. Placebo-controlled trial of sertraline in the treatment of children with generalized anxiety disorder. Am J Psychiatry 2001, 158:2008-2014. 10.1176/appi.ajp.158.12.2008, 11729017.
17. Covin R, Ouimet AJ, Seeds PM, Dozois DJ. A meta-analysis of CBT for pathological worry among clients with GAD. J Anxiety Disord 2008, 22:108-116. 10.1016/j.janxdis.2007.01.002, 17321717.
18. Lowe S, O'Kane A. National Allied Health Workforce Report. 2004, Services for Australian Rural and Remote Allied Health Inc.
19. Zetterqvist K, Maanmies J, Strom L, Andersson G. Randomized controlled trial of internet-based stress management. Cogn Behav Ther 2003, 32:151-160. 10.1080/16506070302316, 16291546.
20. Spence SH, Holmes JM, March S, Lipp OV. The feasibility and outcome of clinic plus internet delivery of cognitive-behavior therapy for childhood anxiety. J Consult Clin Psychol 2006, 74:614-621. 10.1037/0022-006X.74.3.614, 16822117.
21. Carlbring P, Nordgren LB, Furmark T, Andersson G. Long-term outcome of Internet-delivered cognitive-behavioural therapy for social phobia: a 30-month follow-up. Behav Res Ther 2009, 47:848-850. 10.1016/j.brat.2009.06.012, 19631312.
22. Australian Bureau of Statistics Household Use of Information Technology. 2005-2006 Report 8146.0. 2006, Australian Bureau of Statistics.
23. Klein B, Richards JC, Austin DW. Efficacy of internet therapy for panic disorder. J Behav Ther Exp Psychiatry 2006, 37:213-238. 10.1016/j.jbtep.2005.07.001, 16126161.
24. Lange A, Ven JP, Schrieken B, Smit M. 'Interapy' burnout: prevention and therapy of burnout via the internet. Verhaltenstherapie 2004, 14:190-199.
25. 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:e16. 10.2196/jmir.7.2.e16, 1550641, 15998607.
26. Griffiths KM, Christensen H, Jorm AF, Evans K, Groves C. Effect of web-based depression literacy and cognitive-behavioural therapy interventions on stigmatising attitudes to depression: randomised controlled trial. Br J Psychiatry 2004, 185:342-349. 10.1192/bjp.185.4.342, 15458995.
27. Strom L, Pettersson R, Andersson G. Internet-based treatment for insomnia: A controlled evaluation. Journal of Consulting and Clinical Psychology 2000, 72:113-120.
28. Gollings EK, Paxton SJ. Comparison of internet and face-to-face delivery of a group body image and disordered eating intervention for women: a pilot study. Eat Disord 2006, 14:1-15. 10.1080/10640260500403790, 16757445.
29. Beacon. , http://www.beacon.anu.edu.au
30. Draper M, Rees CS, Nathan PR. Internet-Based Self-Management of Generalised Anxiety Disorder: A Preliminary Study. Behaviour Change 2008, 25:229-244.
31. 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. Australian and New Zealand Journal of Psychiatry 2009, 43:905-912.
32. Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998, 59(Suppl 20):22-33. quiz 34-57.
33. Christensen H, Griffiths KM, Mackinnon AJ, Kalia K, Batterham P, Kenardy J, Eagleson C, Bennett K. Protocol for a randomised controlled trial investigating the effectiveness of an online e health application for the prevention of Generalised Anxiety Disorder. BMC Psychiatry 2010, 10:25. 10.1186/1471-244X-10-25, 2848219, 20302678.
34. Stein DJ. Comorbidity in generalized anxiety disorder: impact and implications. J Clin Psychiatry 2001, 62(Suppl 11):29-34. discussion 35-26.
35. Brown TA, Di Nardo PA, Barlow DH. Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV) 1994, San Antonio, TX: Psychological Corporation/Graywind Publications Incorporated.
36. Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med 2006, 166:1092-1097. 10.1001/archinte.166.10.1092, 16717171.
37. Lewis JA. Statistical principles for clinical trials (ICH E9): an introductory note on an international guideline. Stat Med 1999, 18:1903-1942. 10.1002/(SICI)1097-0258(19990815)18:15<1903::AID-SIM188>3.0.CO;2-F, 10440877.
38. McIntosh A, Cohen A, Turnball N, Esmonde L, Dennis P, Eatock J, Feetam C, Hague J, Hughs I, Kelly J, Kosky N, Lear G, Owens L, Ratcliffe J, Salkovskis P. Clinical Guidelines and Evidence Review for Panic Disorder and Generalised Anxiety Disorder. 2004, University of Sheffield/National Collaborating Centre for Primary Care.
39. Kenardy J, McCafferty K, Rosa V. Internet-delivered prevention of anxiety disorders: six-month follow-up. Clinical Psychologist 2006, 10:39-42.
40. Kenardy J, McCafferty K, Rosa V. Internet-delivered indicated prevention for anxiety disorders: a randomised controlled trial. Behavioural and Cognitive Psychotherapy 2003, 31:279-289.
41. Christensen H, Griffiths KM, Jorm AF. Delivering interventions for depression by using the internet: randomised controlled trial. BMJ 2004, 328:265. 10.1136/bmj.37945.566632.EE, 324455, 14742346.
42. Calear AL, Christensen H, Mackinnon A, Griffiths KM, O'Kearney R. The YouthMood Project: A cluster randomized controlled trial of an online cognitive behavioral program with adolescents. J Consult Clin Psychol 2009, 77:1021-1032. 10.1037/a0017391, 19968379.
43. Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol 1983, 51:390-395. 10.1037/0022-006X.51.3.390, 6863699.
44. Griffiths KM, Crisp D, Christensen H, Mackinnon AJ, Bennett K. The ANU WellBeing study: A protocol for a quasi-factorial randomised controlled trial of the effectiveness of an Internet support group and an automated Internet intervention for depression. BMC Psychiatry 2010, 10:20. 10.1186/1471-244X-10-20, 2850878, 20211025.
45. Guy W. Clinical Global Impressions. ECDEU Assessment Manual for Psychopharmacology 1976, 218-222. Rockville, MD: National Institute of Health.
46. Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther 1990, 28:487-495. 10.1016/0005-7967(90)90135-6, 2076086.
47. Wells A. A multidimensional measure of worry: Development and preliminary validation of the Anxious Thoughts Inventory. Anxiety, Stress and Coping 1994, 6:289-299.
48. Dugas MJ, Freeston MH, Provencher MD, Lachance S, Ladouceur R, Gosselin P. Le Questionnaire sur l'inquiétude et l'anxiété. Journal de Thérapie Comportementale et Cognitive 2001, 11:31-36.
49. Peterson RA, Reiss S. The Anxiety Sensitivity Index 1992, Ohio: International Diagnostic Systems.
50. Radloff LS. CES-D Scale: A self-report depression scale for research in the general population. Applied Psychological Measurement 1977, 1:385-401.
51. Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA 1999, 282:1737-1744. 10.1001/jama.282.18.1737, 10568646.
52. Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes M, Eshleman S, Wittchen HU, Kendler KS. Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States. Results from the National Comorbidity Survey. Arch Gen Psychiatry 1994, 51:8-19.
53. Lovibond SH, Lovibond PF. Manual for the Depression Anxiety Stress Scales 1995, Sydney: Psychology Foundation, 2.
54. Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction 1993, 88:791-804. 10.1111/j.1360-0443.1993.tb02093.x, 8329970.
55. Rollman BL, Belnap BH, Mazumdar S, Zhu F, Kroenke K, Schulberg HC, Katherine Shear M. Symptomatic severity of PRIME-MD diagnosed episodes of panic and generalized anxiety disorder in primary care. J Gen Intern Med 2005, 20:623-628. 10.1007/s11606-005-0108-2, 1490149, 16050857.
56. Connor KM, Davidson JR, Churchill LE, Sherwood A, Foa E, Weisler RH. Psychometric properties of the Social Phobia Inventory (SPIN). New self-rating scale. Br J Psychiatry 2000, 176:379-386. 10.1192/bjp.176.4.379, 10827888.
57. Stewart AL, Ware JE. Measuring functional status and well-being: The Medical Outcomes Study approach 1992, Durham, NC: Duke University Press.
58. Anstey KJ, Butterworth P, Jorm AF, Christensen H, Rodgers B, Windsor TD. A population survey found an association between self-reports of traumatic brain injury and increased psychiatric symptoms. J Clin Epidemiol 2004, 57:1202-1209. 10.1016/j.jclinepi.2003.11.011, 15567638.
59. Hwang IK, Morikawa T. Design issues in noninferiority/equivalence trials. Drug Information Journal 1999, 33:1205-1218.
60. Griffiths KM, Christensen H. Review of randomised controlled trials of Internet interventions for mental disorders and related conditions. Clinical Psychologist 2006, 10:16-29.