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

NCT05450614 | Unknown DMC

• 1 other identifier: 20200484
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Depressive Disorder, Major; Cognitive Behavioral Therapy; Clinical Trial; Smartphone; Machine Learning

Outcome Measures

Primary Outcomes (1)

• reduction of Patient Health Questionnaire (PHQ-9) averages

  reduction of PHQ-9 averages. PHQ \>= 9 indicates positive screening for current depressive episode.

  week 12

Secondary Outcomes (3)

• reduction of anxiety symptoms

  week 12

• adherence of the participants to the app

  access for at least 15 minutes per week

• levels of loneliness

  week 12

Study Arms (2)

Thrive app

EXPERIMENTAL

In the Thrive group, access to the application and information regarding its use will be made available to participants. Reassessments and data collection will be performed at 5 points including baseline, 4 weeks, 8 weeks, 12 weeks and 6 months. These five evaluations will be carried out through questionnaires sent to the participants.

Other: Thrive app

TCCG

ACTIVE COMPARATOR

Participants selected for the TCCG group will undergo a new randomization, which will select 50% of patients for immediate start of online sessions and the remainder for inclusion in a waiting list. Participants selected for immediate start will start the CBCT sessions at the time of the initial assessment and will be reassessed at the same points as the Thrive group, also through self-administered online questionnaires. The waiting list will last for 12 weeks, with assessment through self-applicable online scales at the end of the period. Patients who present PHQ≥ 9 will then start online CBCT sessions, according to the protocol above.

Behavioral: TCCG

Interventions

Thrive app OTHER

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.

Thrive app

TCCG BEHAVIORAL

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.

TCCG

Eligibility Criteria

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

You may qualify if:

• have depressive symptoms characterized by PHQ-9≥9 and a diagnosis of Major Depressive Episode through the Mini-International Neuropsychiatric Interview instrument -- own a smartphone
• agree with the treatment objectives and sign the consent form
• age between 18 and 65 years
• be living in Brazil and be fluent in Portuguese.

You may not qualify if:

• pregnancy
• initiation of any psychological treatment within the previous 3 months
• visual impairment that prevents use of the app
• current risk of suicide
• bipolar disorder, schizophrenia, schizoaffective disorder, intellectual disability, and alcohol or drug abuse in the last year.
• Other comorbid medical conditions will also be included, unless they are degenerative (dementia or multiple sclerosis) in a way that could compromise interaction with the application. Participants may be taking psychotropic drugs, including medication for depression, if the medication regimen has not changed in the previous 3 months and if there has been no change over the course of study participation.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil

Location

Related Publications (1)

• Bebber JC, Braga Montezano B, de Souza Vivan A, Antonelli-Salgado T, Aguiar KR, Zimerman A, Shintani AO, Braga Ryff Moreira M, Campos R, Rodrigues L, Frisina Zaffari G, Mallmann G, Fernandes Pulice R, Chiodelli Senger V, Rosendo Vargas J, Zimmer C, Dos Santos Amaral MC, Goncalves Veloso G, Dalla Vecchia GF, Bisognin Lopez JC, Brunoni AR, Rabelo-da-Ponte FD, Passos IC, Braga DT. Digital interventions for depressive symptoms: a randomized clinical trial. Trends Psychiatry Psychother. 2025;47:e20241006. doi: 10.47626/2237-6089-2024-1006. Epub 2025 May 11.

  PMID: 40349367 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Ives C Passos, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julio C Bebber, Medical

CONTACT

+55 54 981498150; pesquisa.app20@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Initially, patients who accept the invitation will be randomized between groups Thrive vs CBCT. In the Thrive group, access to the application and information regarding its use will be made available to participants. Reassessments and data collection will be performed at 5 points: baseline, 4, 8, 12 weeks and 6 months. These five evaluations will be carried out through questionnaires sent to the participants. Participants selected for the TCCG group will undergo a new randomization, which will select 50% of patients for immediate start of online sessions and the remainder for inclusion in a waiting list. Participants selected for immediate start will start the CBCT sessions at the time of the initial assessment and will be reassessed at the same points as the Thrive group, also through self-administered online questionnaires. A 12-week assessment list through online auto scales will take place at the end of the period. Patients at PHQ≥ 9 will initiate CBCT protocol sessions online.

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 11, 2022
• Study Start: August 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: July 11, 2022

Record last verified: 2022-07

Locations

BR (1)