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      A Multisite Non-Inferiority Randomized Controlled Trial of the Efficacy of Cognitive-Behavior Therapy for Generalized Anxiety Disorder Delivered by Videoconference

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          Abstract

          Delivering psychotherapy by videoconference has been studied in a number of clinical trials, but no large controlled trial has involved generalized anxiety disorder (GAD). This multicenter randomized controlled non-inferiority trial was conducted to test if cognitive-behavior psychotherapy delivered by videoconference (VCP) is as effective as cognitive-behavior psychotherapy delivered face-to-face, using a strict margin of tolerance for non-inferiority. A total of 148 adults received a 15-session weekly manualized program. The treatment was based on the intolerance of uncertainty model of GAD. The impact of treatment was assessed using primary (GAD severity), secondary (worry, anxiety, and intolerance of uncertainty) and tertiary (general functioning) variables measured before and after treatment and at 6-month and 12-month follow-ups. Results showed that: (a) the treatment was effective; (b) VCP for GAD was statistically non-inferior to face-to-face psychotherapy on primary, secondary and tertiary measures at all assessment points; (c) change in intolerance of uncertainty significantly predicted change in the primary outcome measure over and above important clinical factors common to all psychotherapies (motivation, working alliance, perceived therapist competence, and client satisfaction). These findings support the use of VCP as a promising treatment option for adults with GAD. Clinical trial registry: ISRCTN#12662027.

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          Diagnostic and Statistical Manual of Mental Disorders

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            Assessment of client/patient satisfaction: Development of a general scale

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              Equivalence Tests

              Scientists should be able to provide support for the absence of a meaningful effect. Currently, researchers often incorrectly conclude an effect is absent based a nonsignificant result. A widely recommended approach within a frequentist framework is to test for equivalence. In equivalence tests, such as the two one-sided tests (TOST) procedure discussed in this article, an upper and lower equivalence bound is specified based on the smallest effect size of interest. The TOST procedure can be used to statistically reject the presence of effects large enough to be considered worthwhile. This practical primer with accompanying spreadsheet and R package enables psychologists to easily perform equivalence tests (and power analyses) by setting equivalence bounds based on standardized effect sizes and provides recommendations to prespecify equivalence bounds. Extending your statistical tool kit with equivalence tests is an easy way to improve your statistical and theoretical inferences.
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                Author and article information

                Contributors
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                Journal
                JCMOHK
                Journal of Clinical Medicine
                JCM
                MDPI AG
                2077-0383
                October 2022
                October 07 2022
                : 11
                : 19
                : 5924
                Article
                10.3390/jcm11195924
                36233791
                eb8e1c31-911b-49b7-9db8-0772f32122e5
                © 2022

                https://creativecommons.org/licenses/by/4.0/

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