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

September 12, 2023 updated by: Anca Dobrean, Babes-Bolyai University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Internalizing problems measured with the Youth Self-Report 11/18 (YSR; Achenbach & Rescorla, 2001)
Time Frame: Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Automatic Thoughts QuestionnaireShort Version (ATQ-SV; Netemeyer et al., 2002)
Time Frame: Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
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)
Time Frame: Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
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)
Time Frame: Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
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)
Time Frame: Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
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
Time Frame: Baseline, 6-month follow-up
Diagnostic interview for anxiety disorders and/or depressive disorders
Baseline, 6-month follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The anxiety subscale from The Beck Youth Inventories™ -Second Edition for Children and Adolescents (Beck, Beck, & Jolly, 2005).
Time Frame: Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
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)
Time Frame: Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
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
Time Frame: Immediately after the intervention (an expected average of 6 weeks)
Satisfaction with the program. Higher scores indicate higher treatment satisfaction
Immediately after the intervention (an expected average of 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Babes-Bolyai University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anca Dobrean, Ph.D., Babes-Bolyai University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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