Digital Interventions as an Add-on Tool in Generalized Anxiety Disorder Treatment
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
Background: Over the last several years, there has been an increase in the popularity and
availability of mobile digital technologies. Many recent studies have evaluated a range of
mobile digital mental health interventions (DMHIs). Smartphone applications, remote
monitoring, tracking devices, and wearable computers such as smartwatches and virtual reality
headsets are being widely used for these studies. Besides that, psychometric scales are being
used to help psychiatrists to improve treatment outcomes. The systematic administration of
symptom rating scales and other assessment tools to help treatment decisions has been called
measurement-based care (MBC) and it has shown good results in improving outcomes and time to
response/remission of psychiatric diseases. As there is little data regarding MBC in
Generalized Anxiety Disorder (GAD), the investigators decided to put technology and MBC
together to study an easy and accessible way to improve the GAD usual treatment. Objectives:
The aim of this study is to evaluate the benefit of digital interventions as an add-on tool
to "treatment-as-usual" (TAU) in GAD patients. Methods: A twelve-weeks randomized clinical
trial will be performed with 60 GAD patients. The control group will receive TAU, defined as
30-minutes online consultation with a trained psychiatrist, consisting in symptoms
evaluation, general orientations about the disorder and use of medication. The consultations
are going to occur biweekly. The digital intervention group (active group) will receive TAU,
associated with two digital tools. The first one consists of psychoeducational videos to be
seen between the sessions and the second one includes self-application of GAD-7 scale the day
before the next scheduled consultation. All these digital interventions are going to be
accessed in a mobile application, called "+PSI", that is already available in Apple Store and
Google Play. The participants are going to be instructed to download the application on their
mobile phones for free. The videos are going to be created especially for this project and
will use animations and educational content, being of short duration (average 3 minutes).
GAD-7 scale, and Hamilton Anxiety Scale (HAM-A) are going to be applied at baseline and at
the end of the follow up by a blind rater. The investigators are also going to test the
application tools usability using the System Usability Scale (SUS). Intermediate and
follow-up evaluations will be performed to assess the speed and maintenance of improvement,
respectively.