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Completed

NCT Number: NCT04182061

Internet Transdiagnostic-CBT for Anxiety and Depression in Adolescents

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 an active control condition (ACC) on the primary (anxiety and depression) and secondary (transdiagnostic and positive factors) outcome measures. The study is a randomized controlled trial with two arms (an experimental group and an active control condition). Assessment is contucted at pre-treatment, post-treatment, and at 3-, 6- and 12-month follow-up. For ethical reasons, participants in the ACC condition are offered the opportunity to receive the experimental condition (i.e., the iUP-A) following the completion of the post-treatment assessment.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bonifacio Sandín

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The AMTE protocol

Behavioral

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 8 modules: (1) Unerstanting emotional problems and behaviors and motivational enhancement, (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, and (8) Relapse prevention.

Other names: "Aprende a Manejar tus Emociones" (AMTE) Protocol

Primary outcomes

  1. 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.

    Time frame: 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.

  2. 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.

    Time frame: Up to 12 months.

    Symptoms of anxiety.

  3. 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.

    Time frame: Up to 12 months.

    Symptoms of depression.

Secondary outcomes

  1. 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.

    Time frame: Up to 12 months.

    Positive and negative (neuroticism) affectivity.

  2. Change on The Childhood Anxiety Sensitivity Index (CASI) (Silverman et al.,1991) at pre, post-intervention and 3, 6 and 12 months follow-up.

    Time frame: Up to 12 months.

    Anxiety sensitivity.

  3. 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.

    Time frame: Up to 12 months.

    Emotional avoidance.

  4. 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.

    Time frame: Up to 12 months.

    Life satisfaction.

  5. 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.

    Time frame: Up to 12 months.

    Symptoms of pathological worry.

  6. 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.

    Time frame: Up to 12 months.

    Symptoms of social anxiety.

  7. 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.

    Time frame: Up to 12 months.

    Symptoms of panic disorder severity.

Sponsors and collaborators

Lead sponsor

Universidad Nacional de Educación a Distancia

Other

Collaborators

  • Ministerio de Economía y Competitividad, Spain

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 2, 2019
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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