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Clinical Trial Summary

This controlled, three-arm, randomized (1:1:1), multi-site trial will evaluate the efficacy, feasibility and acceptability of cognitive-behavioral therapy (CBT)-based online guided and unguided self-help intervention to reduce Generalized Anxiety Disorder (GAD) in Indian university students. The investigators aim to assess if these novel electronic health (eHealth) interventions can be integrated into Indian university systems to increase access to efficacious, less stigmatized, and cost-effective mental healthcare.


Clinical Trial Description

Students from three Indian colleges will be invited to complete an online, self-report survey. Based on their answers, they are categorized into clinical, subclinical, and asymptomatic for Generalized Anxiety Disorder (GAD). Those who meet the diagnostic criteria for GAD as detailed in the Diagnostic and Statistical Manual of Mental Disorders (DSM), 4th Edition are classified as clinical. Those who score a 5.7 or above using dimensional scoring of the GAD-Q-IV but are not "clinical" are classified as subclinical. All others are asymptomatic. After ruling out those with a clinical PTSD diagnosis (scoring 38 or above on the PCL5) and those currently receiving mental healthcare treatment, those who are clinical and subclinical are offered the opportunity to use one of the online programs. Those who accept are randomized between a guided self-help program, a self-help program, and a waitlist control group. Each student who enrolls will be reassessed at post-intervention (3 months) and followup (6 months later, or 9 months after completing baseline). Additionally, those who are classified as asymptomatic are invited to complete additional followup surveys at 3 and 9 months to provide data on anxiety symptom change over time. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02410265
Study type Interventional
Source Stanford University
Contact
Status Completed
Phase N/A
Start date January 2015
Completion date December 2016

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