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. Author manuscript; available in PMC: 2017 Oct 20.
Published in final edited form as: J Clin Trials. 2014 Oct 9;4(5):188. doi: 10.4172/2167-0870.1000188

Table 1.

Inclusion Criteria and Source Document

Inclusion Criteria Source Assessor
Age ≥ 18 years Self-report Study nurse, Study Coordinator
DSM IV Axis I diagnosis of GAD as the primary anxiety disorder Structured Clinical Interview for DSM-IV (SCID) Study nurse, Diagnostician
Baseline GAD-7 ≥ 10 GAD-7 (self-report) Study nurse, Study Coordinator
Clinical Global Impression rating ≥ 4 (≥ ‘moderate’) Clinical Global Impression (CGI) Study nurse
Not taking anti-anxiety medication (e.g., BZ, buspirone, SSRI, SNRI) Baseline visit Study nurse
Not taking antidepressant, mood stabilizer, or tranquilizer therapy for a prior Axis I mood disorder that is in remission Baseline visit Study nurse
Able to provide signed informed consent Baseline visit Study nurse, Study Coordinator
Able to participate in a 38-week study Baseline visit Study nurse, Study Coordinator
Final, overall eligibility Principal Investigator