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

Primary Purpose

Anxiety Disorders, Social Anxiety Disorder, Generalized Anxiety Disorder

Status

Completed

Phase

Not Applicable

Locations

Romania

Study Type

Interventional

Intervention

Transdiagnostic Internet-delivered REBT

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring transdiagnostic, anxiety, depression, REBT, adolescents, Internet intervention

Eligibility Criteria

12 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Babeș-Bolyai University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Transdiagnostic Internet-delivered REBT

Waitlist

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

The Adolescent Peer Relations Instrument (APRI; Parada, 2000)

Change in bullying victimization from baseline. Higher scores indicate higher levels of peer victimization.

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

Full Information

NCT ID

NCT04179526

First Posted

November 14, 2019

Last Updated

September 12, 2023

Sponsor

Babes-Bolyai University

1. Study Identification

Unique Protocol Identification Number

NCT04179526

Brief Title

Transdiagnostic Internet-delivered REBT Intervention for Adolescents' Internalizing Problems

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

January 25, 2020 (Actual)

Primary Completion Date

May 30, 2022 (Actual)

Study Completion Date

December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Babes-Bolyai University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety Disorders, Social Anxiety Disorder, Generalized Anxiety Disorder, Panic Disorder, Persistent Depressive Disorder, Major Depressive Disorder

Keywords

transdiagnostic, anxiety, depression, REBT, adolescents, Internet intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

106 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transdiagnostic Internet-delivered REBT

Arm Type

Experimental

Arm Description

Arm Title

Waitlist

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Transdiagnostic Internet-delivered REBT

Intervention Description

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.

Primary Outcome Measure Information:

Title

Internalizing problems measured with the Youth Self-Report 11/18 (YSR; Achenbach & Rescorla, 2001)

Description

Change in self-reported internalizing problems from baseline to post-treatment, at 6 months post treatment. Higher scores indicate higher levels of internalizing problems.

Time Frame

Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up

Secondary Outcome Measure Information:

Title

Automatic Thoughts QuestionnaireShort Version (ATQ-SV; Netemeyer et al., 2002)

Description

Change in negative automatic thoughts from baseline. Higher scores indicating higher levels of negative automatic thoughts.

Time Frame

Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up

Title

The child and adolescent scale of irrationality (CASI; Bernard & Cronan, 1999)

Description

Change in irrational beliefs from baseline. Higher scores indicate higher levels of irrational beliefs.

Time Frame

Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up

Title

The Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents, The Revised Version - adolescent version (Kiddo-KINDL; Ravens-Sieberer, & Bullinger, 1998)

Description

Change in quality of life from baseline from baseline. Higher scores indicate higher levels of quality of life.

Time Frame

Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up

Title

The Adolescent Peer Relations Instrument (APRI; Parada, 2000)

Description

Change in bullying victimization from baseline. Higher scores indicate higher levels of peer victimization.

Time Frame

Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up

Title

Principal diagnosis based on Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria

Description

Diagnostic interview for anxiety disorders and/or depressive disorders

Time Frame

Baseline, 6-month follow-up

Other Pre-specified Outcome Measures:

Title

The anxiety subscale from The Beck Youth Inventories™ -Second Edition for Children and Adolescents (Beck, Beck, & Jolly, 2005).

Description

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.

Time Frame

Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up

Title

The depression subscale from the Beck Youth Inventories™ -Second Edition for Children and Adolescents (Beck et al., 2005)

Description

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.

Time Frame

Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up

Title

Client Satisfaction Scale

Description

Satisfaction with the program. Higher scores indicate higher treatment satisfaction

Time Frame

Immediately after the intervention (an expected average of 6 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anca Dobrean, Ph.D.

Organizational Affiliation

Babeș-Bolyai University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Babeș-Bolyai University

City

Cluj-Napoca

State/Province

Cluj

ZIP/Postal Code

400015

Country

Romania

12. IPD Sharing Statement

Plan to Share IPD

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Transdiagnostic Internet-delivered REBT Intervention for Adolescents' Internalizing Problems

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