Transdiagnostic Internet-delivered REBT Intervention for Adolescents' Internalizing Problems

Major Depressive Disorder Clinical Trial

— REBTonAd  

Official title:

The Efficacy and Mechanisms of Change of a Transdiagnostic Internet-delivered REBT Intervention for Adolescents With Internalizing Problems: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04179526
• Other study ID #: PN-III-P4-ID-PCE-2016-0861
• Status: Completed
• Phase: N/A
• Start date: January 25, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2023
• Source: Babes-Bolyai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Generalized Anxiety Disorder
• Major Depressive Disorder
• Panic Disorder
• Persistent Depressive Disorder
• Phobia, Social
• Social Anxiety Disorder

Intervention

Behavioral:
• Transdiagnostic Internet-delivered REBT
The protocol is based on Rational Emotive and Behavioral Therapy (REBT; Ellis, 1962, 1994). The program will consist of 8 modules, delivered online over six weeks.

Locations

Country	Name	City	State
Romania	Babe?-Bolyai University	Cluj-Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Babes-Bolyai University

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The anxiety subscale from The Beck Youth Inventories™ -Second Edition for Children and Adolescents (Beck, Beck, & Jolly, 2005).	Change in anxiety subscale from baseline. This subscale contains 20 items, rated on a 4 point Likert scale, with 0 = Never and 3 = Always. The total score is obtained by summing the 20 items, with higher scores indicating higher symptoms of anxiety.	Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
Other	The depression subscale from the Beck Youth Inventories™ -Second Edition for Children and Adolescents (Beck et al., 2005)	Change in depression subscale from baseline. This subscale contains 20 items, rated on a 4 point Likert scale, with 0 = Never and 3 = Always. The total score is obtained by summing the 20 items, with higher scores indicating higher symptoms of depression.	Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
Other	Client Satisfaction Scale	Satisfaction with the program. Higher scores indicate higher treatment satisfaction	Immediately after the intervention (an expected average of 6 weeks)
Primary	Internalizing problems measured with the Youth Self-Report 11/18 (YSR; Achenbach & Rescorla, 2001)	Change in self-reported internalizing problems from baseline to post-treatment, at 6 months post treatment. Higher scores indicate higher levels of internalizing problems.	Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
Secondary	Automatic Thoughts QuestionnaireShort Version (ATQ-SV; Netemeyer et al., 2002)	Change in negative automatic thoughts from baseline. Higher scores indicating higher levels of negative automatic thoughts.	Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
Secondary	The child and adolescent scale of irrationality (CASI; Bernard & Cronan, 1999)	Change in irrational beliefs from baseline. Higher scores indicate higher levels of irrational beliefs.	Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
Secondary	The Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents, The Revised Version - adolescent version (Kiddo-KINDL; Ravens-Sieberer, & Bullinger, 1998)	Change in quality of life from baseline from baseline. Higher scores indicate higher levels of quality of life.	Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
Secondary	The Adolescent Peer Relations Instrument (APRI; Parada, 2000)	Change in bullying victimization from baseline. Higher scores indicate higher levels of peer victimization.	Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
Secondary	Principal diagnosis based on Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria	Diagnostic interview for anxiety disorders and/or depressive disorders	Baseline, 6-month follow-up