Internet Transdiagnostic-CBT for Anxiety and Depression in Adolescents

NCT ID: NCT04182061

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-15
• Study Completion Date: 2023-09-30

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.

Conditions

Anxiety Disorder; Depressive Disorder; Emotional Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

The AMTE protocol

Intervention Type: 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 10 modules: (1) Understanding emotional problems and disorders, (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, (8) How to regulate the emotional avoidance, (9) Respiratory relaxation training, and (10) Relapse prevention.

Waiting List Control Group

Participants in a 12-week waiting list control condition. They will be offered the possibility of receiving the online treatment protocol after the waiting list period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

The 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 10 modules: (1) Understanding emotional problems and disorders, (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, (8) How to regulate the emotional avoidance, (9) Respiratory relaxation training, and (10) Relapse prevention.

Intervention Type: BEHAVIORAL

Other Intervention Names

"Aprende a Manejar tus Emociones" (AMTE) Protocol

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministerio de Economía y Competitividad, Spain

OTHER_GOV

Sponsor Role: collaborator

Universidad Nacional de Educación a Distancia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bonifacio Sandín, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Universidad Nacional de Educación a Distancia, Madrid, Spain

Paloma Chorot, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Universidad Nacional de Educación a Distancia, Madrid, Spain

Rosa M. Valiente, Ph.D.

Role: STUDY_CHAIR

Universidad Nacional de Educación a Distancia, Madrid, Spain

Locations

Bonifacio Sandín

Madrid, , Spain

Countries

Spain

Other Identifiers

BSandin

Identifier Type: -

Identifier Source: org_study_id