ICBT for Anxiety and Depressive Symptoms in Brazilian Young Adults
- Conditions
- Anxiety SymptomsDepressive Symptoms
- Interventions
- Behavioral: Se Cuida Intervention
- Registration Number
- NCT06633679
- Lead Sponsor
- Linkoeping University
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- (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.
- (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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Se Cuida Intervention -
- Primary Outcome Measures
Name Time Method Depression, Anxiety and Stress Scale - DASS-21 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 Outcome Measures
Name Time Method Insomnia Severity Index (ISI) 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).
Almost Perfect Scale - Revised (APS-R) 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.
Brunnsviken Brief Quality of Life Scale (BBQ) 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.
Brazilian adapted version of the Smartphone Addiction Scale-Short Version (SAS-SV) 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.
Social Media Disorder Scale-Short Form (SMDS-SF) 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.
Depression, Anxiety and Stress Scale - DASS-21 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.
Trial Locations
- Locations (1)
University of São Paulo - Department of Psychology, Faculty of Philosophy, Sciences and Languages of Ribeirão Preto
🇧🇷Ribeirão Preto, SP, Brazil