Internet Transdiagnostic-CBT for Anxiety and Depression in Adolescents

Not Applicable

Completed

• Conditions: Anxiety Disorder; Emotional Disorder; Depressive Disorder
• Interventions: Behavioral: The AMTE protocol

• Registration Number: NCT04182061
• Lead Sponsor: Universidad Nacional de Educación a Distancia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-15
• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-12-02
• Status Verified: 2022-11
• Primary Completion: 2023-06-30
• Study Completion: 2023-09-30
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The AMTE Protocol	The AMTE protocol	Will receive the AMTE ("Aprende a Manejar tus Emociones") Protocol; this is a modified UP-A adapted as an internet-based program of T-CBT, consisting in 10 modules delivered over 12 weeks.

Primary Outcome Measures

Name	Time	Method
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.	Up to 12 months.	Symptoms of anxiety (panic disorder, social phobia, separation anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder) and depressive disorders symptoms.
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.	Up to 12 months.	Symptoms of depression.
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.	Up to 12 months.	Symptoms of anxiety.

Secondary Outcome Measures

Name	Time	Method
Change on The Childhood Anxiety Sensitivity Index (CASI) (Silverman et al.,1991) at pre, post-intervention and 3, 6 and 12 months follow-up.	Up to 12 months.	Anxiety sensitivity.
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.	Up to 12 months.	Emotional avoidance.
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.	Up to 12 months.	Symptoms of social anxiety.
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.	Up to 12 months.	Symptoms of panic disorder severity.
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.	Up to 12 months.	Life satisfaction.
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.	Up to 12 months.	Positive and negative (neuroticism) affectivity.
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.	Up to 12 months.	Symptoms of pathological worry.

Trial Locations

Locations (1)

Bonifacio Sandín; 🇪🇸 Madrid, Spain