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Active, Not Recruiting

NCT Number: NCT06633679

ICBT for Anxiety and Depressive Symptoms in Brazilian Young 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anxiety Symptoms Anxiety Disorders Behavior Behavioral Symptoms Depression Depressive Symptoms Mental Disorders

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ribeirão Preto, São Paulo, 14040-901, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: In recruitment and at the end of treatment after 8 weeks

    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).

  2. Almost Perfect Scale - Revised (APS-R)

    Time frame: In recruitment and at the end of treatment after 8 weeks

    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.

  3. Brunnsviken Brief Quality of Life Scale (BBQ)

    Time frame: In recruitment and at the end of treatment after 8 weeks

    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.

  4. 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

    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.

  5. Social Media Disorder Scale-Short Form (SMDS-SF)

    Time frame: In recruitment and at the end of treatment after 8 weeks

    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.

  6. Depression, Anxiety and Stress Scale - DASS-21

    Time frame: In recruitment and at the end of treatment after 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

Se Cuida - Internet-delivered Cognitive Behavioral Therapy for Anxiety and Depressive Symptoms in Brazilian Emerging Adults

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 9, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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