ClinicalTrials.gg
CompletedNCT04182061Updated May 13, 2026

Internet Transdiagnostic-CBT for Anxiety and Depression in Adolescents

An interventional study of The AMTE protocol in Anxiety Disorder, Depressive Disorder and Emotional Disorder, sponsored by Universidad Nacional de Educación a Distancia. Completed at 1 site in Spain. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by Universidad Nacional de Educación a Distancia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Anxiety Disorder
  • Depressive Disorder
  • Emotional Disorder

Keywords

  • Transdiagnostic-CBT, anxiety, Depression, Internet-Delivered
03

In context

Anxiety Disorders

7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's enrollment of 60 is below the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Universidad Nacional de Educación a Distancia is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Having identified Spanish as the first official language spoken and having good reading comprehension in Spanish.
  • Reliable internet access.
  • Meeting the 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    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 8 modules delivered over 7-8 weeks.

    Behavioral: The AMTE protocol

  • No intervention
    Active Control Condition (ACC)

    Participants in a 7/8-week active control condition (ACC). They will be offered the possibility of receiving the online treatment protocol after the active control period.

Interventions

  • BehavioralThe 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 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.

    Also known as: "Aprende a Manejar tus Emociones" (AMTE) Protocol

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What researchers measure

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.

    Symptoms of anxiety (panic disorder, social phobia, separation anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder) and depressive disorders symptoms.

    Time frame: Up to 12 months.

  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.

    Symptoms of anxiety.

    Time frame: Up to 12 months.

  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.

    Symptoms of depression.

    Time frame: Up to 12 months.

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.

    Positive and negative (neuroticism) affectivity.

    Time frame: Up to 12 months.

  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.

    Anxiety sensitivity.

    Time frame: Up to 12 months.

  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.

    Emotional avoidance.

    Time frame: Up to 12 months.

  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.

    Life satisfaction.

    Time frame: Up to 12 months.

  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.

    Symptoms of pathological worry.

    Time frame: Up to 12 months.

  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.

    Symptoms of social anxiety.

    Time frame: Up to 12 months.

  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.

    Symptoms of panic disorder severity.

    Time frame: Up to 12 months.

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Study locations

1 site
  • Bonifacio Sandín
    Madrid, Madrid 28040, Spain
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2019 to primary completion in Jun 2023, 43 months.

Of 3,836 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 43 months is above that.

Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2019
First posted
Dec 2, 2019
StartActual
Nov 15, 2019
Primary completionActual
Jun 30, 2023
CompletionActual
Sep 30, 2023
Last update
May 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04182061
Lead sponsor
Universidad Nacional de Educación a Distancia
Collaborators
Ministerio de Economía y Competitividad, Spain
Responsible party
Sponsor
First posted
Dec 2, 2019
Start date
Nov 15, 2019
Primary completion
Jun 30, 2023
Completion
Sep 30, 2023
Last update
May 13, 2026

Study contacts

Bonifacio Sandín, Ph.D.
principal investigator · Universidad Nacional de Educación a Distancia, Madrid, Spain
Paloma Chorot, Ph.D.
principal investigator · Universidad Nacional de Educación a Distancia, Madrid, Spain
Rosa M. Valiente, Ph.D.
study chair · Universidad Nacional de Educación a Distancia, Madrid, Spain

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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