Transdiagnostic Internet-delivered REBT Intervention for Adolescents' Internalizing Problems (REBTonAd)

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

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

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders; Generalized Anxiety Disorder; Major Depressive Disorder; Social Anxiety Disorder; Panic Disorder; Persistent Depressive Disorder
• Intervention / Treatment: Behavioral: Transdiagnostic Internet-delivered REBT

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400015
      • Babes-Bolyai University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transdiagnostic Internet-delivered REBT; Protocol is based on Rational Emotive Therapy (Ellis, 1962, 1994), structured in 8 modules delivered over 6 weeks (Module 1- Introduction and psychoeducation about emotions, Module 2 - Psychoeducation anxiety and depression, Module 3 - Relaxation, Module 4 - Negative patterns of thinking and cognitive restructuring, Module 5 - Problem solving, Module 6 - Exposure and Behavioral activation, Module 7 - Positive emotions and Module 8 - Gaining maintenance)	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.
No Intervention: Waitlist; Participants in the control group will complete pre-treatment and post-treatment assessments. After participants in the experimental group complete post-treatment assessment, they will receive the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Client Satisfaction Scale	Satisfaction with the program. Higher scores indicate higher treatment satisfaction	Immediately after the intervention (an expected average of 6 weeks)

Collaborators and Investigators

• Sponsor: Babes-Bolyai University
• Investigators: Principal Investigator: Anca Dobrean, Ph.D., Babes-Bolyai University

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2020
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: depression; anxiety; adolescents; transdiagnostic; Internet intervention; REBT
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Phobic Disorders; Depression; Depressive Disorder; Anxiety Disorders; Depressive Disorder, Major; Phobia, Social; Panic Disorder
• Other Study ID Numbers: PN-III-P4-ID-PCE-2016-0861

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No