Clinical trial NCT04182061: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorder
Depressive Disorder
Emotional Disorder
Keywords: Transdiagnostic-CBT, anxiety, Depression, Internet-Delivered
Lead sponsor: Universidad Nacional de Educación a Distancia
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2019-12-02
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
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.
timeFrame: Up to 12 months.
measure: 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.
timeFrame: Up to 12 months.
measure: 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.
timeFrame: Up to 12 months.
Secondary outcomes:
measure: 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.
timeFrame: Up to 12 months.
measure: Change on The Childhood Anxiety Sensitivity Index (CASI) (Silverman et al.,1991) at pre, post-intervention and 3, 6 and 12 months follow-up.
timeFrame: Up to 12 months.
measure: 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.
timeFrame: Up to 12 months.
measure: 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.
timeFrame: Up to 12 months.
measure: 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.
timeFrame: Up to 12 months.
measure: 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.
timeFrame: Up to 12 months.
measure: 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.
timeFrame: Up to 12 months.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Bonifacio Sandín
Study officials:
affiliation: Universidad Nacional de Educación a Distancia, Madrid, Spain
name: Bonifacio Sandín, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Nacional de Educación a Distancia, Madrid, Spain
name: Paloma Chorot, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Nacional de Educación a Distancia, Madrid, Spain
name: Rosa M. Valiente, Ph.D.
role: STUDY_CHAIR
References: