title: 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.
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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02410265 http://clinicaltrials.gov/ct2/show/NCT02410265 (Archived by WebCite at http://www.webcitation.org/6ddqH6Rbt).
authors.affiliation: Behavioral Medicine Lab, Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, United States. nkanuri@stanford.edu.
authors.forename: Nitya
authors.identifier: http://orcid.org/0000-0002-8708-4352
authors.initials: N
authors.lastname: Kanuri
authors.forename: Michelle G
authors.identifier: http://orcid.org/0000-0003-0873-1409
authors.initials: MG
authors.lastname: Newman
authors.forename: Josef I
authors.identifier: http://orcid.org/0000-0003-4099-6431
authors.initials: JI
authors.lastname: Ruzek
authors.forename: Eric
authors.identifier: http://orcid.org/0000-0003-1687-4987
authors.initials: E
authors.lastname: Kuhn
authors.forename: M
authors.identifier: http://orcid.org/0000-0003-0484-6284
authors.initials: M
authors.lastname: Manjula
authors.forename: Megan
authors.identifier: http://orcid.org/0000-0002-0514-5888
authors.initials: M
authors.lastname: Jones
authors.forename: Neil
authors.identifier: http://orcid.org/0000-0001-7006-6361
authors.initials: N
authors.lastname: Thomas
authors.forename: Jo-Anne M
authors.identifier: http://orcid.org/0000-0003-1632-8417
authors.initials: JA
authors.lastname: Abbott
authors.forename: Smita
authors.identifier: http://orcid.org/0000-0002-7811-9381
authors.initials: S
authors.lastname: Sharma
authors.forename: C Barr
authors.identifier: http://orcid.org/0000-0002-4564-6548
authors.initials: CB
authors.lastname: Taylor
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