Depressive Disorder, MajorNCT05450614
Smartphone App Based CBT Versus Online Group CBT: Randomized, Non-inferiority Clinical Trial
A study testing Thrive app and TCCG in people with Depressive Disorder, Major, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Thrive app and TCCG
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre
Ives C Passos, PhD
About this study
Official title: Smartphone App Based Cognitive Behavioral Therapy Versus Online Group Cognitive Behavioral Therapy: Randomized, Non-inferiority Clinical Trial
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.
Read the detailed description
This is a randomized, non-inferiority, three-arm clinical trial, one of which consists of a waiting list. Participants in this study will be selected from an online survey already carried out and approved by the National Research Ethics Committee (Conep), which included 5,000 participants. Patients will be randomized to one of the study arms, application (Thrive) or CBCT (immediate start versus waiting list). Digital interventions in mental health have been gaining strength in the scientific literature, and recently the US Food and Drug Administration (FDA) authorized the digital prescription of an app to treat insomnia. This type of intervention is not a substitute for clinical consultation, but it can be useful in circumstances related to poor access to mental health services, which is a chronic problem in many developing and underdeveloped countries, but which has been exacerbated recently with the COVID-19 pandemic. 19. Of note, CBT is a first-line treatment for combating depressive symptoms, and its use has recently been studied on digital platforms. To help participants in this stage and increase their engagement, the app will provide access to a virtual caregiver and gamification strategies as reported in a recent editorial published in a famous scientific journal.
For this clinical trial, 400 participants with the expected symptoms among those who responded to the aforementioned clinical trial will be invited to be surveyed (National Trial Committee Survey Approved in Research Conducted and Approved).
The goals of this article will not be carried out in the main scientific journals of medicine, but also to assess whether a low-cost digital intervention designed only for reviews where the improvement in mental health is low may the altered symptoms of the included access . It is important that this intervention is useful not only in periods of social isolation, but also when the pandemic ends, since 1) about 50% of patients with depression do not have consultations with mental health professionals; 2) we expect an increase in the number of people with depression after the pandemic, due to its consequences.
Our hypothesis is that the smartphone application, with CBT techniques, although it does not replace the face-to-face consultation, is safe and is not inferior to the CBCT. If shown to be effective, this app will be an innovative, low-cost strategy for dealing with depressive symptoms during and after the pandemic.
- Conditions
- Depressive Disorder, Major
- Being tested
- Thrive app, TCCG
- Keywords
- Depressive Disorder, Major, Cognitive Behavioral Therapy, Clinical Trial, Smartphone, Machine Learning
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrive appOther
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.
TCCGBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: TCCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of Patient Health Questionnaire (PHQ-9) averages
reduction of PHQ-9 averages. PHQ >= 9 indicates positive screening for current depressive episode.
Measured: week 12
Secondary outcomes (3)
reduction of anxiety symptoms
measured by the Generalized Anxiety Disorder Screener (GAD-7). It consists of seven items, arranged on a four-point scale: 0 (never) to 3 (almost every day), with a score ranging from 0 to 21, when measuring the frequency of signs and symptoms of anxiety in the last two weeks. . A positive indicator of signs and symptoms of anxiety disorders is considered to be a value equal to or greater than 10.
Measured: week 12
adherence of the participants to the app
In the Thrive app group, accessing, for at least 15 minutes per week, the app will be considered a membership criterion; in the TCCG group, participation in the sessions will be the adhesion criterion, with a maximum of 4 absences being tolerated.
Measured: access for at least 15 minutes per week
levels of loneliness
measured by the UCLA loneliness scale (UCLA) - brief version of 3 items
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ives C Passos, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450614
- Sponsor's protocol ID
- 20200484
- Status last verified
- Jul 2022
- First submitted
- 5 Jul 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40349367
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone App Based Cognitive Behavioral Therapy Versus Online Group Cognitive Behavioral Therapy: Randomized, Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT05450614
- Acronym / sponsor ID
- 20200484
- Conditions
- Depressive Disorder, Major
- Keywords
- Depressive Disorder, Major, Cognitive Behavioral Therapy, Clinical Trial, Smartphone, Machine Learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, non-inferiority, three-arm clinical trial, one of which consists of a waiting list. Participants in this study will be selected from an online survey already carried out and approved by the National Research Ethics Committee (Conep), which included 5,000 participants. Patients will be randomized to one of the study arms, application (Thrive) or CBCT (immediate start versus waiting list). Digital interventions in mental health have been gaining strength in the scientific literature, and recently the US Food and Drug Administration (FDA) authorized the digital prescription of an app to treat insomnia. This type of intervention is not a substitute for clinical consultation, but it can be useful in circumstances related to poor access to mental health services, which is a chronic problem in many developing and underdeveloped countries, but which has been exacerbated recently with the COVID-19 pandemic. 19. Of note, CBT is a first-line treatment for combating depressive symptoms, and its use has recently been studied on digital platforms. To help participants in this stage and increase their engagement, the app will provide access to a virtual caregiver and gamification strategies as reported in a recent editorial published in a famous scientific journal.
For this clinical trial, 400 participants with the expected symptoms among those who responded to the aforementioned clinical trial will be invited to be surveyed (National Trial Committee Survey Approved in Research Conducted and Approved).
The goals of this article will not be carried out in the main scientific journals of medicine, but also to assess whether a low-cost digital intervention designed only for reviews where the improvement in mental health is low may the altered symptoms of the included access . It is important that this intervention is useful not only in periods of social isolation, but also when the pandemic ends, since 1) about 50% of patients with depression do not have consultations with mental health professionals; 2) we expect an increase in the number of people with depression after the pandemic, due to its consequences.
Our hypothesis is that the smartphone application, with CBT techniques, although it does not replace the face-to-face consultation, is safe and is not inferior to the CBCT. If shown to be effective, this app will be an innovative, low-cost strategy for dealing with depressive symptoms during and after the pandemic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Thrive app | Experimental | Other: Thrive appIn 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. |
| TCCG | Active comparator | Behavioral: TCCGParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrive appThe 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. | Other | Thrive app |
| TCCGIn 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. | Behavioural | TCCG |
Primary outcome
reduction of Patient Health Questionnaire (PHQ-9) averages
Time frame: week 12
reduction of PHQ-9 averages. PHQ >= 9 indicates positive screening for current depressive episode.
3 secondary outcomes
reduction of anxiety symptoms
Time frame: week 12
adherence of the participants to the app
Time frame: access for at least 15 minutes per week
levels of loneliness
Time frame: week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Derived from this study: PubMed 40349367Bebber 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.
Related trials for Depressive Disorder, Major
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2
A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
Major Depressive Episode (MDE), Major Depressive Disorder (MDD)
RecruitingPhase 1
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
Depression, Major Depressive Disorder
Not yet recruiting
Acceptance and Committment Therapy Combined With Ketamine in Difficult-to-Treat Depression.
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ives C Passos, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrive app and TCCG in people with Depressive Disorder, Major, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julio C Bebber, Medical (+55 54 981498150, pesquisa.app20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of Patient Health Questionnaire (PHQ-9) averages (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05450614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.