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Internet Transdiagnostic-CBT for Anxiety and Depression in Adolescents

Primary Purpose

Anxiety Disorder, Depressive Disorder, Emotional Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
The AMTE protocol
Sponsored by
Universidad Nacional de Educación a Distancia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorder focused on measuring Transdiagnostic-CBT, anxiety, Depression, Internet-Delivered

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bonifacio SandínRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The AMTE Protocol

Waiting List Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 20, 2019
Last Updated
November 14, 2022
Sponsor
Universidad Nacional de Educación a Distancia
Collaborators
Ministerio de Economía y Competitividad, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT04182061
Brief Title
Internet Transdiagnostic-CBT for Anxiety and Depression in Adolescents
Official Title
Internet-Delivered Transdiagnostic CBT Program to Improve Access for Treatment of Anxiety and Depression in Adolescents: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Nacional de Educación a Distancia
Collaborators
Ministerio de Economía y Competitividad, Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder, Depressive Disorder, Emotional Disorder
Keywords
Transdiagnostic-CBT, anxiety, Depression, Internet-Delivered

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The AMTE Protocol
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting List Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The AMTE protocol
Other Intervention Name(s)
"Aprende a Manejar tus Emociones" (AMTE) Protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Title
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.
Description
Symptoms of anxiety.
Time Frame
Up to 12 months.
Title
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.
Description
Symptoms of depression.
Time Frame
Up to 12 months.
Secondary Outcome Measure Information:
Title
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.
Description
Positive and negative (neuroticism) affectivity.
Time Frame
Up to 12 months.
Title
Change on The Childhood Anxiety Sensitivity Index (CASI) (Silverman et al.,1991) at pre, post-intervention and 3, 6 and 12 months follow-up.
Description
Anxiety sensitivity.
Time Frame
Up to 12 months.
Title
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.
Description
Emotional avoidance.
Time Frame
Up to 12 months.
Title
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.
Description
Life satisfaction.
Time Frame
Up to 12 months.
Title
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.
Description
Symptoms of pathological worry.
Time Frame
Up to 12 months.
Title
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.
Description
Symptoms of social anxiety.
Time Frame
Up to 12 months.
Title
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.
Description
Symptoms of panic disorder severity.
Time Frame
Up to 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bonifacio Sandín, Ph.D.
Phone
913986254
Email
bsandin@psi.uned.es
First Name & Middle Initial & Last Name or Official Title & Degree
Paloma Chorot, Ph.D.
Phone
913987940
Email
pchorot@psi.uned.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonifacio Sandín, Ph.D.
Organizational Affiliation
Universidad Nacional de Educación a Distancia, Madrid, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paloma Chorot, Ph.D.
Organizational Affiliation
Universidad Nacional de Educación a Distancia, Madrid, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosa M. Valiente, Ph.D.
Organizational Affiliation
Universidad Nacional de Educación a Distancia, Madrid, Spain
Official's Role
Study Chair
Facility Information:
Facility Name
Bonifacio Sandín
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paloma S Chorot, Ph.D.
Phone
913987940
Email
pchorot@psi.uned.es
First Name & Middle Initial & Last Name & Degree
Rosa M. Valiente, Ph.D.
Phone
913987988
Email
rmvalien@psi.uned.es
First Name & Middle Initial & Last Name & Degree
Bonifacio Sandín, Ph.D.
First Name & Middle Initial & Last Name & Degree
Paloma Chorot, Ph.D.
First Name & Middle Initial & Last Name & Degree
Rosa M. Valiente, Ph.D.

12. IPD Sharing Statement

Learn more about this trial

Internet Transdiagnostic-CBT for Anxiety and Depression in Adolescents

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