Digital Applications Used in Mental Health Treatment: Two Randomized Studies
August 1, 2019
Altru Health System, Grand Forks, ND
Dr. Feldman reports no financial relationships relevant to this field of study.
SUMMARY POINTS
- The authors of two different studies investigated the use of digital applications (apps) for the delivery of mental health interventions.
- Study 1 was a randomized, controlled trial of 71 children with a diagnosis of autism. A Google Glass with specialized software, wirelessly connected to a smartphone app, provided video and audio cues regarding facial expression. Participants wearing the glasses and performing specific tasks had significant improvement in a socialization scale after six weeks.
- Study 2 was a randomized, controlled study involving 193 adults with acrophobia. Participants were given access to an app delivering virtual reality, cognitive-based therapy via cardboard, low-cost virtual reality goggles. At three months, the intervention group showed significant acrophobia symptom reduction.
SYNOPSIS: Researchers found an improvement in socialization in children with autism and a decrease in acrophobic (fear of heights) symptoms in adults in two distinct studies using different forms of virtual reality and digital applications.
SOURCES: Voss C, Schwartz J, Daniels J, et al. Effect of wearable digital intervention for improving socialization in children with autism spectrum disorder: A randomized clinical trial. JAMA Pediatr 2019; Mar. 25. doi: 10.1001/jamapediatrics.2019.0285. [Epub ahead of print].
Donker T, Cornelisz I, van Klaveren C, et al. Effectiveness of self-guided app-based virtual reality cognitive behavior therapy for acrophobia: A randomized clinical trial. JAMA Psychiatry 2019; Mar. 20. doi: 10.1001/jamapsychiatry.2019.0219. [Epub ahead of print].
“Most people with mental illness are not treated,” concluded a researcher looking at data from a 2007 landmark study published in The Lancet.1 Despite advances in treatment of mental illness since this study, financial concerns, lack of providers, and perceived stigma remain strong barriers to appropriate and timely mental health intervention.2,3
It is no wonder that efforts to provide cost-efficient, easily accessible, and stigma-free mental health care are rising. As internet access has spread, interest in providing this care via digital delivery has heightened. Reflecting the popularity of online solutions, numerous lay and medical publications have started publishing lists of “best mental health apps.”4-6 Yet, rigorous studies evaluating the effectiveness of apps in a controlled fashion are lacking.
Two pioneering studies counter this trend. Both published in JAMA, the authors of these two disparate studies evaluated mental health care digital delivery via different forms of virtual reality. The first was a randomized, controlled study of 71 California children with autism, and the second was a randomized, controlled study of 193 Dutch adults with acrophobia. These studies involved distinct disorders and participants; the link between the studies is that both are among the first controlled investigations of the effect of digital apps in the treatment of mental illness.
The prevalence of autism spectrum disorder (ASD) is rising. Affecting one in 59 U.S. children and approximately 2-3% of the adult population, this neurodevelopmental disorder is a lifelong condition, often identified in early childhood and typically before a child reaches school age. ASD presents with a cluster of symptoms across a range or spectrum of severity. Core symptoms of this disorder include difficulty attaining age-normalized social skills (i.e., maintaining eye contact), interpreting facial expressions accurately, and understanding nuances of conversation. These skill deficits often lead to functional impairment and unwanted behaviors, including aggression and self-harm.7,8
ASD medications are limited to symptom relief and targeted to specific behaviors. Socialization rarely can be addressed with psychotropic agents. Applied Behavior Analysis (ABA) is a specialized type of behavioral therapy that has evidence of efficacy in this realm. Unfortunately, the expense, time commitment (20 hours weekly over a two-year span), and shortage of qualified therapists make attaining ABA unrealistic for many young patients.7,8
Voss et al looked at enhancing gains made with ABA by adding on a digital intervention dubbed Superpower Glass (SG) by the children who first piloted the device. Seventy-one children between the ages of 6 and 12 years who were diagnosed with ASD and lived within driving distance of Stanford University were sorted randomly into two groups: treatment as usual plus intervention and treatment as usual. To qualify, the children needed to be receiving ABA therapy at least twice weekly.
The SG “smart vision” system runs via Google Glass (worn by the child) and a connected smartphone app, which provides real-time audio and visual information to the wearer of the glasses regarding facial expressions, engagement, and recognition of emotion. Each family in the intervention arm was instructed to have participants wear the glasses and perform specific social recognition tasks (as set by the app) four times weekly for 20 minutes over six weeks. A family member managed the connected app for most sessions, but this was tasked to the ABA therapist at least once a week.
Of the 71 children beginning the study, 52 remained at study termination. More than half of the families of the 13 dropouts from the intervention arm explained that the device was not suitable for the child (“too challenging”). The remining six dropouts were from the control arm. One family reported the child wearing the glasses had an adverse effect.
At the six-week study conclusion, improvement was measured with several validated scales looking at various aspects of socialization. Although all scales demonstrated improvement and all results were assessed using an intention-to-treat analysis, the only scale showing statistical significance of improvement was the Vineland Adaptive Behavior Scale (VABS-2). This scale measures several skills, including communication and adaptive behaviors.9 At the initial six-week mark, a mean treatment impact of 4.58 points (P = 0.005) was measured for the intervention group.
However, at the six-week follow-up, mean improvement on the VABS-2 declined in the SG group and was no longer statistically significant.
The Voss et al study raises several questions regarding home digital delivery of an intervention for mental health. It is encouraging that initial results demonstrated significant impact. However, the loss of effectiveness over time is essential to understand before drawing firm conclusions and may point to a need for a longer treatment course, a practice period, or other factors.
It also is important to understand that ASD occurs on a spectrum. Inclusion criteria in this study did not account or match for disease severity, and the relatively large dropout rate may be reflective of this heterogeneity. On the other hand, the relatively homogenous geographic selection criteria raises other limitations to generalizability of results. Finally, the authors did not control for the additional time parents were spending with the intervention participants, making it difficult to know if any outcomes were due to this interaction with or without the SG.
Even with these limitations, the study results showed the potential for addressing difficult-to-treat symptoms with a relatively low-cost, easily accessible, home digital intervention for appropriate patients with ASD.
In the second study, Donker et al noted that specific phobias are more common than many providers may realize. With a lifetime prevalence of 16.6 among U.S. adults, this group of disorders holds the dubious honor of ranking among the most common mental health disorder in this population — second only to depression.10
According to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), specific phobias have seven diagnostic criteria. In general, diagnosis requires functional impairment due to significant fear or anxiety about a specific situation out of proportion to actual danger. Without adequate treatment, these disorders may worsen and lead to depression and generalized anxiety. Evidence-based treatment largely supports the use of cognitive-behavioral therapy (CBT) with progressive exposure to the situation or feared stimulus. Some studies suggest that virtual exposure to the stimuli may be effective as well.10-12
Acrophobia, the most common of all specific phobias, is a specific phobia regarding fear of heights.13 In this Dutch study, participants from the general population were recruited via advertising. Eligibility criteria included attaining a score above a set cutoff on the Acrophobic Questionnaire-Anxiety (AQ), falling into the 18- to 65-year-old age range; and having access to an Android device with a gyroscope. Prospective participants with severe depression and/or psychotropic medication were not eligible for inclusion in this study.
After randomizing the 193 eligible participants into an intervention and wait list group, the intervention group received access to ZeroPhobia, an Android app providing a self-paced virtual reality (VR) CBT program. In addition, participants were asked to purchase cardboard VR goggles ($10).
The CBT program was designed to be completed over three weeks and was broken into six segments ranging from 5 to 40 minutes. The VR exposure, an immersive experience navigable via gaze, was introduced in the third segment. Practice sessions were encouraged throughout the entire period.
The primary outcome was score on the AQ (the same questionnaire used to determine eligibility) and measured at baseline, three weeks, and at the three-month follow-up. Secondary outcomes, including a depression inventory and a measure of user friendliness of the intervention, also were completed online. Researchers blinded to the intervention interpreted all scores, and all results were subjected to an intention-to-treat analysis.
Results at post-test and at three months showed a significant reduction in AQ scores among the intervention group, with a mean score reduction of 40 points (P < 0.001) and a significantly large effect size as indicated by Cohen d = 1.14 (95% confidence interval, 0.84-1.44.) The effect size increased to d = 2.68 when comparing baseline and three-month follow-up scores within the intervention group only.
The secondary measures showed no change in the depression inventory symptoms and a general rating of “user-friendly” for the app. There were no deleterious side effects reported, but 24 respondents noted at least transient symptoms of cyber sickness, or nausea and dizziness when using the VR exposure. Notably, there was a correlation between experience of cyber sickness and intensity of response.
As there appeared to be significant benefit at the post-test mark, all wait-list control participants were given access to the app at that time. Thus, the three-month follow-up statistics did not include a comparison to control, but showed an extension of previously noted gains in specified measures as indicated by the substantial increase in effect size noted above.
Notably, one of the study limitations was a large pretreatment attrition rate of 22% in the intervention group because of incompatibility of the app with the participant device. Other limitations included a homogenous sample, data reliance on self-reported app use and self-reported scoring, and the relatively limited follow-up period.
Overall, the robust results are encouraging and show that VR CBT delivered via a digital app may be a useful tool in the fight against acrophobia.
When considering the two studies as a whole, it is clear that although both showed promise, the results are preliminary and are unable to be generalized until further research and well-designed studies are completed. However, the significance of both lie in the process of subjecting newer techniques in mental health care to the time-tested process of rigorous scientific validation. The beauty of many online therapeutic interventions is easy accessibility, but this access becomes a double-edged sword when the validation process is missing.
Our job as providers includes helping patients sort through a plethora of medical information and direct them toward accurate and useful facts to aid in
wellness and treatment. Patients with mental health disorders often are in a vulnerable state. Studies with scientifically backed data can elevate a treatment discussion and remind all involved of the need to have sufficient information when beginning the process of weighing potential risks and benefits for a particular intervention.
REFERENCES
- Thornicroft G. Most people with mental health needs are not treated. Lancet 2007;370:807-808.
- Ritchie H. Global mental health: Five key insights which emerge from the data. Our World in Data. Available at: https://ourworldindata.org/global-mental-health. Accessed July 14, 2019.
- Mental Health America. The state of mental health in America 2018. Available at: https://www.mentalhealthamerica.net/issues/state-mental-health-america-2018. Accessed July 14, 2019.
- Nichols H. The top 10 mental health apps. Medical News Today. Available at: https://www.medicalnewstoday.com/articles/320557.php. Accessed July 14, 2019.
- Shelton J. Top 25 best mental health apps: An effective alternative for when you can't afford therapy? PSYCOM. Available at: https://www.psycom.net/25-best-mental-health-apps. Accessed July 14, 2019.
- Thomas J. The best mental health apps for depression, anxiety & beyond. betterhelp.com Available at: https://www.betterhelp.com/advice/general/the-best-mental-health-apps-for-depression-anxiety-beyond/. Accessed July 14, 2019.
- MedlinePlus. Autism Spectrum Disorder. Available at: https://medlineplus.gov/autismspectrumdisorder.html. Accessed July 14, 2019.
- Centers for Disease Control and Prevention. Autism Spectrum Disorder. Available at: https://www.cdc.gov/ncbddd/autism/treatment.html. Accessed July 14, 2019.
- Science Direct. Vineland Adaptive Behavior Scale. Available at: https://www.sciencedirect.com/topics/medicine-and-dentistry/vineland-adaptive-behavior-scale. Accessed July 14, 2019.
- Kessler RC, Petukhova M, Sampson NA, et al. Twelve-month and lifetime prevalence and lifetime morbid risk of anxiety and mood disorders in the United States. Int J Methods Psychiatr Res 2012;21:169-184.
- Impact of the DSM-IV to DSM-5 Changes on the National Survey on Drug Use and Health. Available at: https://www.ncbi.nlm.nih.gov/books/NBK519704/table/ch3.t11/. Accessed July 14, 2019.
- Anxiety and Depression Association of America. Specific Phobias. Available at: https://adaa.org/understanding-anxiety/specific-phobias. Accessed July 14, 2019.
- Kapfhammer HP, Fitz W, Huppert D, et al. Visual height intolerance and acrophobia: Distressing partners for life. J Neurol 2016;263:1946-1953.
Researchers found an improvement in socialization in children with autism and a decrease in acrophobic (fear of heights) symptoms in adults in two distinct studies using different forms of virtual reality and digital applications.
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