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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental |
| |
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | In recruitment and at the end of treatment after 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of São Paulo - Department of Psychology, Faculty of Philosophy, Sciences and Languages of Ribeirão Preto | Ribeirão Preto | São Paulo | 14040-901 | Brazil |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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.
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|
| 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. |
| 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. | 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. | 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. | 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. | In recruitment and at the end of treatment after 8 weeks |