Christensen, H., Guastella, A. J., Mackinnon, A. J., Griffiths, K. M., Eagleson, C., Batterham, P. J., et al. (2010). Protocol for a randomized controlled trial investigating the effectiveness of an online e-health application compared to attention placebo or sertraline in the treatment of generalized anxiety disorder. Trials, 11(48).
You may be tired of hearing me discuss Internet platforms for delivering health promotion programs in my research columns. I do seem to be in a rut, but I can't help it! It seems to me that using the Internet to reach people who don't typically have access to health promotion opportunities is an obvious solution to overcoming so many barriers, especially environmental ones. So, bear with me - I promise I will pursue other interests soon.
When I found this latest article, I thought, so what exactly is an "online e-health application"? It seems obvious, but I wanted to make sure I wasn't blurring technology lines and avoid being yelled at by a certain friend/coworker who always corrects me when I use the terms "social networking" and "social media" interchangeably. But I think I'm safe. It is pretty much what it sounds like: e-health is the application of Internet and other related technologies in the healthcare industry to improve access, efficiency, effectiveness, and other important aspects of healthcare in order to ultimately improve health status of the client or patient. In that definition though, doesn't saying online and e-health in the same term seem redundant? But now I'm just getting picky . . . .
This article uses e-health to target the treatment of generalized anxiety disorder (GAD), a high-prevalence psychiatric disorder that is associated with low rates of treatment. The importance of finding effective methods seems crucial with GAD, as the community cost associated with it is high and if effective treatment is found in young adulthood, it has the potential to reduce ongoing disability and costs.
Common existing treatments for GAD are cognitive behavioral therapy (CBT), which is a type of mental health counseling, and drug treatments such as selective serotonin reuptake inhibitors (SSRIs). Sertraline, along with SSRIs, is usually a first-line pharmacologic treatment. Despite benefits of both of these treatments, many patients do not or are not able to access them. Whether this is due to confidentiality concerns or to rural and remote locations, e-health applications seem to be a potential solution to both of these reasons. However, these treatments are not as well established for GAD relative to other anxiety disorders, such as post-traumatic stress disorder, eating disorders, and others.
Purpose
Two studies have indicated promise of such an intervention with GAD. One is a preliminary case study of an Internet self-management program and the other is the first randomized controlled trial (RCT) of an Internet-based CBT program. Based on this promise, this RCT attempts to evaluate the effectiveness of e-health applications relative to these other gold-standard pharmacological treatments as well as against a placebo control. In addition, researchers are aiming to investigate participant characteristics that predict outcome, adherence, satisfaction, and acceptability of the intervention.
Participants
Targeted participants are 18 to 30 years old and must have GAD as their primary diagnosis according to the Mini-International Neuropsychiatric Interview (MINI).
Method
Participants were randomized into one of three treatment conditions with stratification for gender and secondary diagnosis of depression. The treatment groups were:
- E-health Application: The E-couch website consists of 10 modules and is comprised of 4 sections (psychoeducation, cognitive behavior therapy, relaxation, and physical activity). Some components include progressive muscle relaxation (PMR), mindfulness meditation, and physical activity based on the Stages of Change Theory.
- Pharmacological Treatment: Sertraline will be dosed daily at 25 mg and increased to 50 mg/day after one week if the participant is tolerable to it. After 4 weeks, those without clinical response according to the Clinical Global Impressions scale (CGI) will be increased to 100 mg/day, again, if tolerable to it.
- Placebo Control: The HealthWatch website is an online program that will provide information about various health topics each week including environmental health, nutrition myths, heart health, activity, medication, the effects of temperature, oral health, blood pressure and cholesterol, calcium, and back pain. HealthWatch was developed for a separate study, though it was not associated with a reduction in anxiety or depressive symptoms over time.
Treatments will last for 10 weeks with a 12-month follow-up. Measurements will be taken at screening, baseline, post-test, and 6 and 12 months post-test. Time on either website, number of completed modules, length of module use, and frequency of access will be automatically recorded for each participant. All participants in both website groups will receive the same amount of clinical team exposure (weeks 1, 2, 5, and 10) to monitor progress and symptoms. The CGI will be used at each of these points to gauge treatment response. Weekly modules will be 30 to 60 minutes long. In weeks 1, 2, 5, and 10, the psychologist will encourage the use of the modules but will not elaborate.
Primary outcome measures:
- Level of anxiety symptoms (GAD-7 scale)
- Reduction of at least 20% (GAD-7 scale)
- Presence or absence of GAD diagnoses (ADIS-IV)
Secondary outcomes:
- Reduction in worry
- Reduced impact of worry and anxiety on participants' lives
- Reduction of somatic symptoms associated with GAD
- Reduction in anxiety sensitivity
- Reductions in depression symptoms
- Level of psychosocial distress
- Reductions in the level of harmful/hazardous alcohol use
- Reduced disability
- Improvements in health knowledge
- Potential risk factors
- Predictors of treatment response
- Stigma toward people with GAD (personal and perceived)
- Perceptions of personal health
- Individuals' ability to identify mental illness in themselves
- Symptoms of social phobia
- Panic disorder symptoms
- Availability of social support
- Adherence
Predictors:
- Childhood adversity
- Life events
- Physical health
- Perceived helpfulness of treatment sources
- Medication use
- Alcohol use
- Smoking
Subsidiary outcomes:
- Direct costs
- Satisfaction of treatment
- Demographics of responders vs. non-responders
Results:
You're going to love this: I am reviewing an article of a study that isn't even complete yet! Participants will be recruited in four cohorts about 2-3 months apart and the trial will end in May 2012. But that's what's so great. We can watch this unfold in real time! It's like when everyone read the first Harry Potter book, then sat on the edges of their seats, waiting for the next installment. Identical situation, right?!
The sample size should have 80% power to detect a moderate effect size and using a correlation of .7 between pre-post test, it will have 80% power to detect differences in change from baseline of .3 standard deviations. Primary effectiveness analyses will be undertaken on an intention-to-treat basis, and mixed-model repeated measures analysis will be used to compare outcome over time across the groups. Comparison of online therapy to sertraline will be undertaken within a non-inferiority/equivalence framework with the non-inferiority margin chosen post hoc and relative risk will be calculated and tested for significance.
Discussion
In hindsight, I'm sure limitations will come to light, but this study is attempting to address limitations in previous RCTs by:
- Using a longer follow-up period (12 months)
- Documenting randomization procedures
- Controlling for the amount of contact received by participants
- Analyzing predictors of treatment response and adherence
- Including cost-effectiveness data
Another reason that I was intrigued by this article and am anxious to see the results is that I believe that it is really important to address the "hidden" disabilities in research and in practice, and I can see e-health applications providing barrier removal for attitudinal barriers as well. So many people are dealing with some sort of psychiatric condition, maybe transient or maybe not, who want and need health promotion and healthy opportunities. If a behavior takes place in an individual that indicates a "surprise" disability, many health and fitness professionals, and people in general, may not have the most appropriate or sympathetic response. Therefore I feel the translation of research into practice for physical as well as more "hidden" disabilities is critically important in order to reach the masses of people.
This is not only one of the first RCTs to use online treatment for GAD, but also the first to compare it with a gold-standard pharmacological treatment. If this proves to be effective, e-health applications offer an attractive and affordable alternative to medication and may be preferred over less anonymous office visits. Stay tuned to find out what happens!