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Completed

NCT Number: NCT04179526

Transdiagnostic Internet-delivered REBT Intervention for Adolescents' Internalizing Problems

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

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Key information

Conditions

Anxiety Disorders Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Generalized Anxiety Disorder Major Depressive Disorder Mental Disorders Mood Disorders Panic Disorder Persistent Depressive Disorder Phobia, Social Phobic Disorders Social Anxiety Disorder

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Babeș-Bolyai University

Cluj-Napoca, Cluj, 400015, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transdiagnostic Internet-delivered REBT

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

Other outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Babes-Bolyai University

Other

Registry information

Official study title

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

Acronym: REBTonAd

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 27, 2019
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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