The Feasibility, Acceptability, and Efficacy of Delivering Internet-Based Self-Help and Guided Self-Help Interventions for Generalized Anxiety Disorder to Indian University Students: Design of a Randomized Controlled Trial

Nitya Kanuri, Michelle G Newman, Josef I Ruzek, Eric Kuhn, M Manjula, Megan Jones, Neil Thomas, Jo-Anne M Abbott, Smita Sharma, C Barr Taylor, Nitya Kanuri, Michelle G Newman, Josef I Ruzek, Eric Kuhn, M Manjula, Megan Jones, Neil Thomas, Jo-Anne M Abbott, Smita Sharma, C Barr Taylor

Abstract

Background: Generalized anxiety disorder (GAD) is one of the most common mental disorders among university students; however, many students go untreated due to treatment costs, stigma concerns, and limited access to trained mental health professionals. These barriers are heightened in universities in India, where there are scant mental health care services and severe stigma surrounding help seeking.

Objective: To evaluate the feasibility, acceptability, and efficacy of Internet-based, or "online," cognitive behavioral therapy (CBT)-based unguided and guided self-help interventions (using the programs GAD Online and Lantern, respectively) to reduce GAD symptoms in students with clinical and subthreshold GAD and, ultimately, reduce the prevalence and incidence of GAD among the student population.

Methods: Students will be recruited via 3 colleges in Hyderabad, India, and referred for a campus-wide online screening. Self-report data will be collected entirely online. A total of 300 qualifying students will be randomized in a 1:1:1 ratio to receive GAD Online, Lantern, or to be in a wait-list control condition, stratified by clinical and subthreshold GAD symptomatology. Students will complete a postintervention assessment after 3 months and a follow-up assessment 6 months later, at which point students in the wait-list control condition will receive one of the programs. The primary outcome is GAD symptom severity at 3 months postintervention. Secondary outcomes include GAD caseness at 9 months, other anxiety and depression symptoms, self-efficacy, and functional measures (eg, sleep, social functioning) at 3 and 9 months, respectively. Primary analyses will be differences between each of the intervention groups and the wait-list control group, analyzed on an intention-to-treat (ITT) basis using mixed-design ANOVA.

Results: The study commenced in February 2015. The sample was recruited over a 3-week period at each college. The trial is expected to end in December 2015.

Conclusions: This trial will be the first to evaluate the use of Internet-based CBT programs compared with a wait-list control group for the treatment of GAD among students in Indian universities. If effective, these programs have the potential to reduce the mental health care treatment gap by providing readily accessible, private, and cost-effective evidence-based care to students with GAD who do not currently receive the treatment they need.

Trial registration: ClinicalTrials.gov NCT02410265 https://ichgcp.net/clinical-trials-registry/NCT02410265 (Archived by WebCite at http://www.webcitation.org/6ddqH6Rbt).

Keywords: Internet-delivered cognitive behavioral therapy (iCBT), generalized anxiety disorder; college health screening; guided self-help; low- and middle-income countries; quality of life; randomized controlled trial.

Conflict of interest statement

Conflicts of Interest: MGN and CBT are on the scientific advisory board of Lantern, which developed the guided self-help anxiety program. However, neither author derives personal financial benefit from the operation of Lantern. MJ is employed at and has equity in Lantern, which is a for-profit company that distributes one of the interventions described in this study. MJ was involved in study design related to using the Lantern technology. She does not have any direct contact with participants. She will not be handling any data nor will she be involved in data analysis. The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
Trial flow chart.
Figure 2
Figure 2
Screenshot of Lantern Internet-based user view.
Figure 3
Figure 3
Screenshot of Mental Health Online’s GAD Online program.

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