ICBT for Anxiety and Depressive Symptoms in Brazilian Young Adults

NCT ID: NCT06633679

Last Updated: 2024-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-12

Study Completion Date

2025-02-28

Brief Summary

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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

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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

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Anxiety Symptoms Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

Group Type EXPERIMENTAL

Se Cuida Intervention

Intervention Type BEHAVIORAL

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.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Se Cuida Intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* (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.

Exclusion Criteria

* (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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Gerhard Andersson

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of São Paulo - Department of Psychology, Faculty of Philosophy, Sciences and Languages of Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Se Cuida Brazil

Identifier Type: -

Identifier Source: org_study_id

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