Internet Transdiagnostic-CBT for Anxiety and Depression in Adolescents

NCT04182061 | Completed

• 1 other identifier: BSandin
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Transdiagnostic-CBT, anxiety, Depression, Internet-Delivered

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 12 months.

• 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.

  Up to 12 months.

• 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.

  Up to 12 months.

Secondary Outcomes (7)

• 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.

  Up to 12 months.

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

  Up to 12 months.

• 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.

  Up to 12 months.

• 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.

  Up to 12 months.

• 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.

  Up to 12 months.

Study Arms (2)

The AMTE Protocol

EXPERIMENTAL

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.

Behavioral: The AMTE protocol

Waiting List Control Group

NO INTERVENTION

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.

Interventions

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 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.

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

The AMTE Protocol

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional de Educación a Distancia: lead
• Ministerio de Economía y Competitividad, Spain: collaborator

Study Sites (1)

Bonifacio Sandín

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder; Depression

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Bonifacio Sandín, Ph.D.

  Universidad Nacional de Educación a Distancia, Madrid, Spain

  PRINCIPAL INVESTIGATOR

• Paloma Chorot, Ph.D.

  Universidad Nacional de Educación a Distancia, Madrid, Spain

  PRINCIPAL INVESTIGATOR

• Rosa M. Valiente, Ph.D.

  Universidad Nacional de Educación a Distancia, Madrid, Spain

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: December 2, 2019
• Study Start: November 15, 2019
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: January 9, 2024

Record last verified: 2022-11

Locations

ES (1)