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Anxiety DisorderNCT04182061

Internet Transdiagnostic-CBT for Anxiety and Depression in Adolescents

A study testing The AMTE protocol in people with Anxiety Disorder and Depressive Disorder, run by Universidad Nacional de Educación a Distancia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 12 to 18 years
What is being tested?
The AMTE protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSpain
Study dates
15 Nov 2019to 30 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Bonifacio Sandín

    Madrid, Madrid, 28040

Other trials in Spain

About this study

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

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.

Being tested
The AMTE protocol
Keywords
Transdiagnostic-CBT, anxiety, Depression, Internet-Delivered
Medical subject headings
Anxiety Disorders, Depressive Disorder, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The AMTE protocolBehavioural

    Also called "Aprende a Manejar tus Emociones" (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.

Study groups in NCT04182061
Study groupRoleWhat they receive
The AMTE ProtocolExperimentalWill 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.
Receives: Behavioral: The AMTE protocol
Active Control Condition (ACC)No interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: Up to 12 months.

Secondary outcomes (7)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Up to 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2019
  2. Study start15 Nov 2019
  3. Primary completion30 Jun 2023
  4. Study completion30 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled clinical trial
Masking
Single blind
Who is masked
Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04182061
Sponsor's protocol ID
BSandin
Status last verified
Nov 2022
First submitted
20 Nov 2019
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing The AMTE protocol in people with Anxiety Disorder and Depressive Disorder, run by Universidad Nacional de Educación a Distancia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04182061.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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