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Smartphone App Based CBT Versus Online Group CBT: Randomized, Non-inferiority Clinical Trial

NCT05450614 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-07-11

No results posted yet for this study

Summary

The present research project aims to compare the efficacy and safety of an intervention based on a smartphone application, which uses CBT techniques, to online group cognitive behavioral therapy (CBCT), in improving depressive symptoms.

The project also has supplemental analysis to predict who will respond to the CBT intervention using the application. For this analysis, machine learning algorithms, a set of techniques from the field of artificial intelligence, will be used to create a predictive calculator for response to interventions. The analysis protocol used for this analysis will be in accordance with that proposed in task Force of the International Society for Bipolar Disorders.

Conditions

  • Depressive Disorder, Major

Interventions

OTHER

Thrive app

The application has already been developed using the Flutter framework and provides users with the main CBT-based strategies to reduce depressive symptoms. In order to engage users, gamification strategies were also implemented. Some examples are 1) development and achievement: quiz on psychoeducation with rewards; 2) epic sense: like the messages in the psychoeducation session; 3) unpredictability: surprise quiz. An avatar will also be available for the participant, who will gain experience as he interacts with some of the application's functions. Finally, participants will receive weekly videos of less than 5 minutes with tips on how to use the app. There will be a total of 12 videos with psychoeducation tips and how to use the application.

BEHAVIORAL

TCCG

In the literature, there is no single protocol for the treatment of depression through CBCT, therefore, a systematized protocol was developed for this study, aiming to structure and unify this intervention. Participants selected for the TCCG group will be randomly divided into 10 groups of 10 members each. The TCCG will be held through weekly meetings, exclusively online. Twelve sessions lasting 90 minutes each will be applied. The structuring of the sessions is based on the cognitive-behavioral model, starting with psychoeducation about the disorder and self-knowledge, starting with cognitive restructuring and relapse prevention. Homework will be part of the protocol. The sessions will be held on a digital platform (Google Meet) and access instructions will be provided to the participants of this group in the evaluation interview.

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Ives C Passos, PhD · Federal University of Rio Grande do Sul

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-06-30
Completion
2023-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05450614 on ClinicalTrials.gov