Digital Interventions As an Add-on Tool in Generalized Anxiety Disorder Treatment

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.

Conditions

• Generalized Anxiety Disorder

Interventions

OTHER

Digital Interventions

The digital interventions will consist of two parts: A) Psychoeducation videos: Five psychoeducation videos on mental health and GAD will be produced especially for the research to be watched by the patient between consultations. These videos will last approximately 3 minutes, will use animations and educational content. They will be available on "+PSI" app. The topics of the videos will be as follows: Normal Anxiety versus Pathological Anxiety; Sleep Hygiene; Healthy Eating and Mental Health; Physical Exercise and Mental Health; Excessive Consumption of Alcohol and Drugs. B) GAD-7 Scale: The patient will be instructed to respond to the GAD-7 self-administered scale the day before their next scheduled appointment. This instrument will also be available free of charge on +PSI mobile app and will be used to guide clinical management.

DRUG

Treatment as Usual

The usual treatment will be standardized as follows: Biweekly online consultations (via WhatsApp or Google Meet) previously scheduled, 20/30 minutes-long, with a trained psychiatrist. The patient will receive only clinical, not psychotherapeutic treatment. The psychiatrist will be instructed to perform an assessment of symptoms, general guidelines on the pathology, use of medication when necessary. The medication of choice, when necessary, will be fluoxetine, as it is the medication for the treatment of GAD available free of charge in our health system in Brazil.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre

  lead OTHER

Principal Investigators

• Gisele G Manfro, PhD · Hospital de Clínicas de Porto Alegre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-01

Primary Completion

2023-08-23

Completion

2024-02-28

Countries

• Brazil

Study Locations