Clinical trial NCT06633679: ICBT for Anxiety and Depressive Symptoms in Brazilian Young Adults
Official title: Se Cuida - Internet-delivered Cognitive Behavioral Therapy for Anxiety and Depressive Symptoms in Brazilian Emerging Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety Symptoms
Depressive Symptoms
Keywords: internet-delivered interventions
anxiety
depression
young adults
cognitive-behavioral therapy
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2024-10-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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\&#39;s text messaging channel. The program was adapted to Brazilian culture from previous work.

Eligibility criteria: 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.

Primary outcomes:
measure: Depression, Anxiety and Stress Scale - DASS-21
timeFrame: In recruitment; in every two weeks during treatment; and at the end of treatment after 8 weeks
Secondary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: In recruitment and at the end of treatment after 8 weeks
measure: Almost Perfect Scale - Revised (APS-R)
timeFrame: In recruitment and at the end of treatment after 8 weeks
measure: Brunnsviken Brief Quality of Life Scale (BBQ)
timeFrame: In recruitment and at the end of treatment after 8 weeks
measure: Brazilian adapted version of the Smartphone Addiction Scale-Short Version (SAS-SV)
timeFrame: In recruitment and at the end of treatment after 8 weeks
measure: Social Media Disorder Scale-Short Form (SMDS-SF)
timeFrame: In recruitment and at the end of treatment after 8 weeks
measure: Depression, Anxiety and Stress Scale - DASS-21
timeFrame: In recruitment and at the end of treatment after 8 weeks
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: University of São Paulo - Department of Psychology, Faculty of Philosophy, Sciences and Languages of Ribeirão Preto
state: SP
Study officials:
References: