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.
BACKGROUND
Generalised anxiety disorder (GAD) is a high prevalence, chronic psychiatric disorder which commonly presents early in the lifespan. Internet e-health applications have been found to be successful in reducing symptoms of anxiety and stress for post traumatic stress disorder (PTSD), panic disorder, social phobia and depression. However, to date, there is little evidence for the effectiveness of e-health applications in adult GAD. There are no studies which have directly compared e-health applications with recognised evidence-based medication. This study aims to determine the effectiveness of a web-based program for treating GAD relative to sertraline and attention placebo.


METHODS
120 community-dwelling participants, aged 18-30 years with a clinical diagnosis of GAD will be recruited from the Australian Electoral Roll. They will be randomly allocated to one of three conditions: (i) an online treatment program for GAD, E-couch (ii) pharmacological treatment with a selective serotonin re-uptake inhibitor (SSRI), sertraline (a fixed-flexible dose of 25-100 mg/day) or (iii) an attention control placebo, HealthWatch. The treatment program will be completed over a 10 week period with a 12 month follow-up.


CONCLUSIONS
As of February 2010, there were no registered trials evaluating the effectiveness of an e-health application for GAD for young adults. Similarly to date, this will be the first trial to compare an e-health intervention with a pharmacological treatment.


BACKGROUND
Current Controlled Trials ISRCTN76298775.
Christensen
Helen
H
Centre for Mental Health Research, The Australian National University, Canberra, Australia. Helen.Christensen@anu.edu.au
Guastella
Adam J
AJ
Mackinnon
Andrew J
AJ
Griffiths
Kathleen M
KM
Eagleson
Claire
C
Batterham
Philip J
PJ
Kalia
Kanupriya
K
Kenardy
Justin
J
Bennett
Kylie
K
Hickie
Ian B
IB
D000293:Adolescent; D000328:Adult; D014151:Anti-Anxiety Agents / Q000627:therapeutic use*; D001008:Anxiety Disorders / Q000175:diagnosis / Q000188:drug therapy / Q000523:psychology / Q000628:therapy*; D001315:Australia; D015928:Cognitive Behavioral Therapy; D005260:Female; D006801:Humans; D020407:Internet; D008297:Male; D015990:Placebo Effect; D012107:Research Design; D020280:Sertraline / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D014151:Anti-Anxiety Agents; D020280:Sertraline