Anxiety SymptomsNCT06633679
ICBT for Anxiety and Depressive Symptoms in Brazilian Young Adults
A study testing Se Cuida Intervention in people with Anxiety Symptoms and Depressive Symptoms, run by Linkoeping University at 1 site in Brazil.
Trial summary
This study aims to investigate the effects of a selfguided internet-based cognitive behavioral therapy (ICBT) program on depressive and anxiety symptoms in young Brazilian adults. Treatment group will be compared to a waiting list control group. Participants will be recruited in Brazil with a nationwide recruitment. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Symptoms, Depressive Symptoms
- What is being tested?
- Se Cuida Intervention
- 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
- 12 Mar 2024to Feb 2025
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- (1) age between 18 and 24 years old; (2) have a device with Internet access that allows access to the platform; (3) speak and read Brazilian Portuguese.
Who cannot join
- (1) having a severe psychiatric diagnosis such as bipolar disorder and schizophrenia; (2) having severe suicidal ideation or reported suicidal intent; (3) reporting substance abuse; (4) being in an ongoing psychological and/or psychiatric treatment; (5) changing psychiatric medication less than 3 months before the treatment starts; (6) scoring extremely severe on all three subscales of DASS-21 (28+ for depression, 20+ for anxiety and 34+ for stress.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo - Department of Psychology, Faculty of Philosophy, Sciences and Languages of Ribeirão Preto
Ribeirão Preto, São Paulo, 14040-901
About this study
Official title: Se Cuida - Internet-delivered Cognitive Behavioral Therapy for Anxiety and Depressive Symptoms in Brazilian Emerging Adults
This study aims to investigate the effects of a selfguided internet-based cognitive behavioral therapy (ICBT) program on depressive and anxiety symptoms in young Brazilian adults. Treatment group will be compared to a waiting list control group. Participants will be recruited in Brazil with a nationwide recruitment.
Read the detailed description
This is a randomized controlled trial carried out to evaluate the effects of an internet-based cognitive behavioral program for depressive and anxiety symptoms in young Brazilians adults. The program consists of 8 weeks of treatment and is carried out through an online platform. During treatment, participants have the support of a therapist who can be reached on demand via the platform\'s text messaging channel. The program was adapted to Brazilian culture from previous work.
- Conditions
- Anxiety Symptoms, Depressive Symptoms
- Being tested
- Se Cuida Intervention
- Keywords
- internet-delivered interventions, anxiety, depression, young adults, cognitive-behavioral therapy
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Se Cuida InterventionBehavioural
The intervention consist in an internet based cognitive behavioural therapy program delivered through a online platform. Intervention consist of 8 weeks with 8 weekly modules assigned to the participants. The program has been translated and adapted to the Brazilian and is based on CBT techniques focused on managing psychological symptoms of anxiety and depression in young people. Out of a total 14 modules adaptaded, 8 will be delivered in the treatment: 5 will be available to all participants and 3 will be tailored according to the initial assessment and interviews. The intervention is self-guided with support on demand, meaning that when participants need support, they could chat directly through the platform text message channel with a psychoteraphist responsible for them. Also, once a week each participants receive feedbacks regarding their work on the program\'s exercises.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: Se Cuida Intervention |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, Anxiety and Stress Scale - DASS-21
Measures depression, anxiety, and stress symptoms in the last week. Primary outcomes will be depressive and anxiety subscales. The instrument consists of 21 questions evaluated with a Likert Scale ranging from 0 (does not apply to me at all) to 3 (applied to me very much or most of the time). The scores for each subscale were proposed by the original authors and range from normal, mild, moderate, severe, and extremely severe symptomatology. The severity rating can be easily accessed in the Brazilian version.
Measured: In recruitment; in every two weeks during treatment; and at the end of treatment after 8 weeks
Secondary outcomes (6)
Insomnia Severity Index (ISI)
Measure sleep problems with 7 questions ranging from 0 to 4 points answers. Symptomatology can vary between non-significant insomnia (0-7), lower limit (8-14), moderate clinical insomnia (15- 21) and severe clinical insomnia (22-28).
Measured: In recruitment and at the end of treatment after 8 weeks
Almost Perfect Scale - Revised (APS-R)
Measures perfectionism symptoms in 23 itens. It has three subscales (Discrepancy, Standards, and Order), with a Likert Scale ranging from 1 (strongly disagree) to 7 (strongly agree). Higher values indicate greater perfectionism, with a cut-off score of 42 for the Standards subscale for rating perfectionism. Maladaptive perfectionism is considered if also Discrepancy subscale is 42 or higher.
Measured: In recruitment and at the end of treatment after 8 weeks
Brunnsviken Brief Quality of Life Scale (BBQ)
Measures quality of life with 12 items referring to satisfaction and importance of six areas of life, with responses ranging from 0 (completely disagree) to 5 (completely agree). The scores can range from 0 to 96 points, with a higher score indicating higher quality of life. Clinical populations demonstrated lower scores compared to non-clinical populations, with a mean of 38.7 and 60.1, respectively.
Measured: In recruitment and at the end of treatment after 8 weeks
Brazilian adapted version of the Smartphone Addiction Scale-Short Version (SAS-SV)
Measures problematic Internet use. The scale assesses problematic smartphone use and consists of 33 questions assessed by a Likert Scale ranging from 1 (strongly disagree) to 6 (strongly agree). Problematic use is considered with a cut-off of 31 points for men and 33 for women.
Measured: In recruitment and at the end of treatment after 8 weeks
Social Media Disorder Scale-Short Form (SMDS-SF)
This instrument was translated and adapted for this work. The original scale was developed for adolescents based on the DSM-5 Internet Dependence Disorder criteria and has 9 items assessed by dichotomous yes (1) and no (0) responses. Problematic social media use is considered with a cut-off of 5 points. Additionally, four questions will be included for understanding social medias used, daily usage time, activities performed with social media and primary use.
Measured: In recruitment and at the end of treatment after 8 weeks
Depression, Anxiety and Stress Scale - DASS-21
Measures depression, anxiety, and stress symptoms in the last week. Stress wil be evaluated as a second outcome. The instrument consists of 21 questions evaluated with a Likert Scale ranging from 0 (does not apply to me at all) to 3 (applied to me very much or most of the time). The scores for each subscale were proposed by the original authors and range from normal, mild, moderate, severe, and extremely severe symptomatology. The severity rating can be easily accessed in the Brazilian version.
Measured: In recruitment and at the end of treatment after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start12 Mar 2024
- Primary completion15 Jun 2024
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety SymptomsStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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
- Participants will be randomly allocated to either intervention or control group. Participants in the control group will receive the same treatment once the intervention group has finished the treatment.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633679
- Sponsor's protocol ID
- Se Cuida Brazil
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Se Cuida - Internet-delivered Cognitive Behavioral Therapy for Anxiety and Depressive Symptoms in Brazilian Emerging Adults
- ClinicalTrials.gov ID
- NCT06633679
- Acronym / sponsor ID
- Se Cuida Brazil
- Conditions
- Anxiety Symptoms, Depressive Symptoms
- Keywords
- internet-delivered interventions, anxiety, depression, young adults, cognitive-behavioral therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- Feb 2025 (estimated)
- First posted
- 9 Oct 2024 (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.
This study aims to investigate the effects of a selfguided internet-based cognitive behavioral therapy (ICBT) program on depressive and anxiety symptoms in young Brazilian adults. Treatment group will be compared to a waiting list control group. Participants will be recruited in Brazil with a nationwide recruitment.
Detailed description
This is a randomized controlled trial carried out to evaluate the effects of an internet-based cognitive behavioral program for depressive and anxiety symptoms in young Brazilians adults. The program consists of 8 weeks of treatment and is carried out through an online platform. During treatment, participants have the support of a therapist who can be reached on demand via the platform\'s text messaging channel. The program was adapted to Brazilian culture from previous work.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to either intervention or control group. Participants in the control group will receive the same treatment once the intervention group has finished the treatment.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Se Cuida Intervention |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (1) age between 18 and 24 years old; (2) have a device with Internet access that allows access to the platform; (3) speak and read Brazilian Portuguese.
Key exclusion criteria (1 listed)
- (1) having a severe psychiatric diagnosis such as bipolar disorder and schizophrenia; (2) having severe suicidal ideation or reported suicidal intent; (3) reporting substance abuse; (4) being in an ongoing psychological and/or psychiatric treatment; (5) changing psychiatric medication less than 3 months before the treatment starts; (6) scoring extremely severe on all three subscales of DASS-21 (28+ for depression, 20+ for anxiety and 34+ for stress.
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 |
|---|---|---|
| Se Cuida InterventionThe intervention consist in an internet based cognitive behavioural therapy program delivered through a online platform. Intervention consist of 8 weeks with 8 weekly modules assigned to the participants. The program has been translated and adapted to the Brazilian and is based on CBT techniques focused on managing psychological symptoms of anxiety and depression in young people. Out of a total 14 modules adaptaded, 8 will be delivered in the treatment: 5 will be available to all participants and 3 will be tailored according to the initial assessment and interviews. The intervention is self-guided with support on demand, meaning that when participants need support, they could chat directly through the platform text message channel with a psychoteraphist responsible for them. Also, once a week each participants receive feedbacks regarding their work on the program\'s exercises. | Behavioural | Intervention group |
Primary outcome
Depression, Anxiety and Stress Scale - DASS-21
Time frame: In recruitment; in every two weeks during treatment; and at the end of treatment after 8 weeks
Measures depression, anxiety, and stress symptoms in the last week. Primary outcomes will be depressive and anxiety subscales. The instrument consists of 21 questions evaluated with a Likert Scale ranging from 0 (does not apply to me at all) to 3 (applied to me very much or most of the time). The scores for each subscale were proposed by the original authors and range from normal, mild, moderate, severe, and extremely severe symptomatology. The severity rating can be easily accessed in the Brazilian version.
6 secondary outcomes
Insomnia Severity Index (ISI)
Time frame: In recruitment and at the end of treatment after 8 weeks
Almost Perfect Scale - Revised (APS-R)
Time frame: In recruitment and at the end of treatment after 8 weeks
Brunnsviken Brief Quality of Life Scale (BBQ)
Time frame: In recruitment and at the end of treatment after 8 weeks
Brazilian adapted version of the Smartphone Addiction Scale-Short Version (SAS-SV)
Time frame: In recruitment and at the end of treatment after 8 weeks
Social Media Disorder Scale-Short Form (SMDS-SF)
Time frame: In recruitment and at the end of treatment after 8 weeks
Depression, Anxiety and Stress Scale - DASS-21
Time frame: In recruitment and at the end of treatment after 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Se Cuida Intervention in people with Anxiety Symptoms and Depressive Symptoms, run by Linkoeping University 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 1 inclusion and 1 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 9 Oct 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression, Anxiety and Stress Scale - DASS-21 (time frame: In recruitment; in every two weeks during treatment; and at the end of treatment after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2024.