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

NCT05375851 | Completed DMC

• 1 other identifier: 54357621.7.0000.5327
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

digital mental health; mobile applications; measurement-based care; GAD-7; psychoeducation; generalized anxiety disorder

Outcome Measures

Primary Outcomes (1)

• Clinical change as measured by the Generalized Anxiety Disorder-7 (GAD-7) scale score

  Patients will be evaluated at the beginning and at the endpoint of the study with the self-administered GAD-7 scale, and the difference found between the deltas (end minus initial) of the control and intervention groups will be considered the primary outcome of the study. The GAD-7 scale score ranges from 0 to 21 points. A score between 5 and 9 points characterizes mild GAD. Between 10 and 14, moderate GAD and between 15 and 21, severe GAD.

  The initial evaluation will take place before session 1 by a blinded evaluator and the final evaluation will take place shortly after the last session (12 weeks of treatment) also by a blinded evaluator.

Secondary Outcomes (7)

• Clinical improvement measured through Hamilton Anxiety (HAM-A) scale scores

  The initial evaluation will take place before session 1 by a blinded evaluator and the final evaluation will take place shortly after the last session (12 weeks of treatment) also by a blinded evaluator.

• Treatment dropout rates

  Session 1 until session 6 (12 weeks long)

• Speed of improvement measured by Hamilton Anxiety Scale (HAM-A)

  Between 4 and 6 weeks after the start of the study (between session 3 and session 4)

• System usability evaluation

  SUS will be applied through study completion, an average of 12 weeks after session 1

• Level of satisfaction with the treatment received

  NPS will be applied through study completion, an average of 12 weeks after session 1

Study Arms (2)

Digital Intervention

EXPERIMENTAL

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. The above digital interventions will be added to the usual GAD treatment.

Other: Digital Interventions; Drug: Treatment as Usual

Control

ACTIVE COMPARATOR

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.

Drug: Treatment as Usual

Interventions

Digital Interventions OTHER

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.

Digital Intervention

Treatment as Usual DRUG

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.

Also known as: Care as Usual

Control; Digital Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older.
• diagnosis of GAD confirmed through MINI.
• access to internet and smartphone (or tablet with internet).

You may not qualify if:

• psychiatric comorbidities more severe than GAD (assessed using CGI).
• suicide risk.
• pregnancy or lactation.
• being in psychological/psychiatric treatment or having been in the last 3 months.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (19)

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MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Gisele G Manfro, PhD

  Hospital de Clínicas de Porto Alegre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: As we are going to use a digital tool as an adjunct to the treatment and as the clinician also needs to guide the patient during this intervention and discuss with him about the content of the videos and the results of the scales, there is no possibility of blinding these parts, however, we opted for blind the evaluator who will carry out the baseline, mid-term and end-of-study evaluations. The study coordinator will talk to each patient to advise them not to reveal which group they participated during the interview with the blinded evaluator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: May 17, 2022
• Study Start: May 1, 2022
• Primary Completion: August 23, 2023
• Study Completion: February 28, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)