ICBT for Anxiety and Depressive Symptoms in Brazilian Young Adults

NCT06633679 | Active Not Recruiting DMC

• 1 other identifier: Se Cuida Brazil
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety Symptoms; Depressive Symptoms

Keywords

internet-delivered interventions; anxiety; depression; young adults; cognitive-behavioral therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  In recruitment; in every two weeks during treatment; and at the end of treatment after 8 weeks

Secondary Outcomes (6)

• Insomnia Severity Index (ISI)

  In recruitment and at the end of treatment after 8 weeks

• Almost Perfect Scale - Revised (APS-R)

  In recruitment and at the end of treatment after 8 weeks

• Brunnsviken Brief Quality of Life Scale (BBQ)

  In recruitment and at the end of treatment after 8 weeks

• Brazilian adapted version of the Smartphone Addiction Scale-Short Version (SAS-SV)

  In recruitment and at the end of treatment after 8 weeks

• Social Media Disorder Scale-Short Form (SMDS-SF)

  In recruitment and at the end of treatment after 8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Behavioral: Se Cuida Intervention

Control group

NO INTERVENTION

Interventions

Se Cuida Intervention 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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

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

Ribeirão Preto, São Paulo, 14040-901, Brazil

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: March 12, 2024
• Primary Completion: June 15, 2024
• Study Completion: February 1, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)