Bonifacio Sandín
Madrid, 28040, Spain
NCT Number: NCT04182061
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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Notify Me12 year–18 year
All sexes
Interventional
Not applicable
Madrid, 28040, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: Up to 12 months.
Symptoms of anxiety.
Time frame: Up to 12 months.
Symptoms of depression.
Time frame: Up to 12 months.
Positive and negative (neuroticism) affectivity.
Time frame: Up to 12 months.
Anxiety sensitivity.
Time frame: Up to 12 months.
Emotional avoidance.
Time frame: Up to 12 months.
Life satisfaction.
Time frame: Up to 12 months.
Symptoms of pathological worry.
Time frame: Up to 12 months.
Symptoms of social anxiety.
Time frame: Up to 12 months.
Symptoms of panic disorder severity.
Universidad Nacional de Educación a Distancia
Other
Internet-Delivered Transdiagnostic CBT Program to Improve Access for Treatment of Anxiety and Depression in Adolescents: A Randomized Controlled Trial
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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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