Clinical trial NCT04179526: Transdiagnostic Internet-delivered REBT Intervention for Adolescents' Internalizing Problems
Official title: The Efficacy and Mechanisms of Change of a Transdiagnostic Internet-delivered REBT Intervention for Adolescents With Internalizing Problems: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Social Anxiety Disorder
Generalized Anxiety Disorder
Panic Disorder
Persistent Depressive Disorder
Major Depressive Disorder
Keywords: transdiagnostic
anxiety
depression
REBT
adolescents
Internet intervention
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 106
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and mechanisms of change of an Internet-delivered transdiagnostic REBT intervention for adolescents with internalizing problems.

Detailed description: The main objectives of this study are to evaluate the efficacy and mechanisms of change of an Internet-delivered Rational Emotive Behavior Therapy for adolescents (12-15 years) diagnosed with a principal anxiety or depressive disorder according to DSM-5 criteria. Participants will be randomly allocated to one of the two groups: experimental (REBTonAd) and waitlist control. The intervention is structured in 8 modules and will be delivered over six weeks. Assessments will be conducted at four time points: baseline, post-treatment, 3-month follow-up, and 6-month follow-up.

Eligibility criteria: Inclusion Criteria:

* Age between 12 and 15 years
* A principal diagnosis of Social Anxiety Disorder, Generalized Anxiety Disorder, Panic Disorder, Persistent Depressive Disorder, or Major Depressive Disorder as defined by DSM-5 (APA, 2013)
* Not currently following another treatment (psychotherapy, pharmacological treatment);
* Internet access
* Ability to read and write Romanian

Exclusion Criteria:

* Suicidal ideation
* Severe depression
* Any physical and mental health acute problem that requires hospitalization
* Diagnosed with autism spectrum disorder, psychosis, bipolar disorder or mental disability

Primary outcomes:
measure: Internalizing problems measured with the Youth Self-Report 11/18 (YSR; Achenbach & Rescorla, 2001)
timeFrame: Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
Secondary outcomes:
measure: Automatic Thoughts QuestionnaireShort Version (ATQ-SV; Netemeyer et al., 2002)
timeFrame: Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
measure: The child and adolescent scale of irrationality (CASI; Bernard & Cronan, 1999)
timeFrame: Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
measure: The Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents, The Revised Version - adolescent version (Kiddo-KINDL; Ravens-Sieberer, & Bullinger, 1998)
timeFrame: Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
measure: The Adolescent Peer Relations Instrument (APRI; Parada, 2000)
timeFrame: Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
measure: Principal diagnosis based on Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
timeFrame: Baseline, 6-month follow-up
Other outcomes:
measure: The anxiety subscale from The Beck Youth Inventories™ -Second Edition for Children and Adolescents (Beck, Beck, & Jolly, 2005).
timeFrame: Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
measure: The depression subscale from the Beck Youth Inventories™ -Second Edition for Children and Adolescents (Beck et al., 2005)
timeFrame: Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
measure: Client Satisfaction Scale
timeFrame: Immediately after the intervention (an expected average of 6 weeks)
Locations:
city: Cluj-Napoca
country: Romania
facility: Babeș-Bolyai University
state: Cluj
Study officials:
affiliation: Babeș-Bolyai University
name: Anca Dobrean, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: