At a glance
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Brief Internet-delivered Cognitive-behavioral Intervention for Children and Adolescents With Anxiety and Depression Symptoms During the COVID-19 Pandemic: a Randomized Clinical Trial
In Brief
A clinical study evaluating Telepsychotherapy and Psychoeducational Videos for Childhood Anxiety Disorder and Childhood Depression. Completed, enrolled 280 participants across 1 site.
Detailed Summary
Investigators developed a brief standardized internet-delivered cognitive-behavioral program for treating anxious and depressive symptoms in children and adolescents in the context of COVID-19 pandemics in Brazil. A 2-arm parallel-randomized controlled clinical trial will be conducted to test the efficacy of this program (intervention group), in comparison with a educational-only intervention program based on videos (active control group). 280 children and adolescents (8 to 17 years-old) with clinically significant anxious and/or depressive symptoms will be recruited through internet and social media. They will be randomized either to the intervention (n=140) or active control group (n=140). Participants will be recruited from across the country. The therapeutic program consists of 5 weekly sessions covering the following contents: education on stress reactions, family communication, relaxation and mindful techniques, emotion recognition, management of irritability, behavioral activation, and cognitive restructuring. The educational program consists of 15 videos covering the same content. Participants in the intervention group will also have access to these videos. Both child/adolescent and at least one caregiver will be required to take part in the sessions (and watch the videos). Participants will be assessed at the beginning (baseline; T0) at the end (endpoint; T1), and 30 days after the intervention (follow-up; T2) with standardized questionnaires, through an interview with a blinded investigator. Participants that develop severe symptomatology requiring further support during the intervention (such as psychiatric pharmacological treatment and/or more intensive psychotherapy) will be referred to adequate treatment. During the week prior to the intervention and the first week after its end, adolescents (older than 12 years-old) in both groups with access to a smartphone will be asked to report their momentary mood, emotions, and stress several times a day using the same smartphone app that will deliver the educational content to both groups. Adolescents will also be asked to install a second smartphone application that captures data from the phone sensors to provide proxies on behaviors associated with depression, such as social isolation (by the proximity with other devices, time spent on social media, as well as environmental sound and light) amount of inactivity (by assessing the maximum distance traveled throughout the day), among others.
Study Details
Timeline
Interventions
5 weekly psychotherapy sessions that will cover the following contents: psychoeducation on stress responses, family communication, relaxation and mindful techniques, emotion recognition, management of irritability, behavioral activation and cognitive restructuring. The sessions will be implemented via the internet by a trained psychologist. Participants will also have access to the psychoeducational videos described at "intervention 2"
15 educational videos to be watched by the families. There will be one video about psychoeducation on stress responses, one about family communication, four about mindfulness and relaxation techniques, two about emotion recognition, one about management of irritability, one about behavioral activation, three about healthy routines, one about cognitive restructuring, and one about management of anxiety crisis.