Internet Transdiagnostic-CBT for Anxiety and Depression in Adolescents

Depressive Disorder Clinical Trial

Official title:

Internet-Delivered Transdiagnostic CBT Program to Improve Access for Treatment of Anxiety and Depression in Adolescents: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04182061
• Other study ID #: BSandin
• Status: Completed
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2022
• Source: Universidad Nacional de Educación a Distancia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study represents the first research program to assess the efficacy of transdiagnostic cognitive behavior therapy (T-CBT) delivered via internet for anxiety and depression in adolescents. The primary aim of the study was to implement the program AMTE (Aprende a Manejar tus Emociones [Learn to Manage Your Emotions]), an internet delivered T-CBT protocol designed to target both anxiety and depression symptoms and disorders (major depression disorder, dysthymic disorder, panic disorder, agoraphobia, generalized anxiety disorder, and social anxiety disorder) in adolescents, and to establish its preliminary efficacy on anxiety and depressive symptomatology. A secondary objective is to demonstrate its potential effect regarding: (a) transdiagnostic measures associated with etiology of emotional disorders including negative affect, anxiety sensitivity, and emotional avoidance, and (b) positive factors including satisfaction with life and positive affect. It is expected that the T-CBT condition will be more effective than the waitlist (WL) control group on the primary (anxiety and depression) and secondary (transdiagnostic and positive factors) outcome measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• Having identified Spanish as the first official language spoken and having good reading comprehension in Spanish.
• Reliable internet access.
• Meeting the DSM-IV diagnosis criteria for more than one emotional disorder (separation anxiety disorder, panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder, specific phobia, major depression disorder, and dysthymia).
• No current participating in cognitive-behavioral therapy.
• No changes in medication for 4 weeks prior to the study; no changes in medication for the next 3 months.

Exclusion Criteria:

• Presence of psychotic symptoms or severe depression.
• Being diagnosed an alcohol and/or substance dependence disorder.
• The presence of high suicidal risk.
• A medical condition which prevents the participant from carry out the psychological treatment.

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Depression
• Depressive Disorder
• Emotional Disorder

Intervention

Behavioral:
• The AMTE protocol
The AMTE program is an adaptation of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A; Ehrenreich-May et al., 2018) to be applied as an internet-based protocol. Like the UP-A, the program AMTE implements a set of core principles to address common factors underling youth anxiety and depressive symptoms. It includes the following 10 modules: (1) Understanding emotional problems and disorders, (2) Getting to know your emotions and behaviors, (3) Enjoy your positive activities, (4) Mindful emotion awareness, (5) Being flexible in your thinking, (6) Confronting physical sensations, (7) Situational emotion exposure, (8) How to regulate the emotional avoidance, (9) Respiratory relaxation training, and (10) Relapse prevention.

Locations

Country	Name	City	State
Spain	Bonifacio Sandín	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Nacional de Educación a Distancia	Ministerio de Economía y Competitividad, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change on The Revised Child Anxiety and Depression Scale-30 (RCADS-30; Sandín et al., 2010) at pre, post-intervention and 3, 6 and 12 months follow-up.	Symptoms of anxiety (panic disorder, social phobia, separation anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder) and depressive disorders symptoms.	Up to 12 months.
Primary	Change on The Anxiety Scale for Children and Adolescents [Escala de Ansiedad para Niños y Adolescentes] (EAN; Sandín et al., 2016) at pre, post-intervention and 3, 6 and 12 months follow-up.	Symptoms of anxiety.	Up to 12 months.
Primary	Change on The Depression Questionnaire for Children and Adolescents [Cuestionario de Depresión para Niños y Adolescentes] (CDN; Sandín et al., 2016) at pre, post-intervention and 3, 6 and 12 months follow-up.	Symptoms of depression.	Up to 12 months.
Secondary	Change on The Children Positive and Negative Affect Schedule [Escalas PANAS para niños y adolescentes] (PANASN; Sandín, 2003) at pre, post-intervention and 3, 6 and 12 months follow-up.	Positive and negative (neuroticism) affectivity.	Up to 12 months.
Secondary	Change on The Childhood Anxiety Sensitivity Index (CASI) (Silverman et al.,1991) at pre, post-intervention and 3, 6 and 12 months follow-up.	Anxiety sensitivity.	Up to 12 months.
Secondary	Change on The Emotional Avoidance Strategy Inventory for Adolescents (EASI-A; Kennedy & Ehrenreich-May, 2016) at pre, post-intervention and 3, 6 and 12 months follow-up.	Emotional avoidance.	Up to 12 months.
Secondary	Change on The Satisfaction with Life Scale for Children (SWLS-C; Sandín et al., 2015) at pre, post-intervention and 3, 6 and 12 months follow-up.	Life satisfaction.	Up to 12 months.
Secondary	Change on The Pen State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger, & Borkovec, 1990) adapted for children and adolescents (PSWQ-11) at pre, post-intervention and 3, 6 and 12 months follow-up.	Symptoms of pathological worry.	Up to 12 months.
Secondary	Change on The Social Anxiety Scale for Children-Revised (SASC-R; La Greca & Stone, 1993) at pre, post-intervention and 3, 6 and 12 months follow-up.	Symptoms of social anxiety.	Up to 12 months.
Secondary	Change on The Self-Reported Panic Disorder Severity Scale (PDSS-SR; Houck, Spiegel, Shear, & Rucci, 2002) at pre, post-intervention and 3, 6 and 12 months follow-up.	Symptoms of panic disorder severity.	Up to 12 months.