NCT04179526

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 25, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

2.3 years

First QC Date

November 14, 2019

Last Update Submit

September 12, 2023

Conditions

Keywords

transdiagnosticanxietydepressionREBTadolescentsInternet intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

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

    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)

    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)

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

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

    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

    Baseline, 6-month follow-up

Other Outcomes (3)

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

    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)

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

  • Client Satisfaction Scale

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

Study Arms (2)

Transdiagnostic Internet-delivered REBT

EXPERIMENTAL

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

Waitlist

NO INTERVENTION

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.

Interventions

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.

Transdiagnostic Internet-delivered REBT

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Babeș-Bolyai University

Cluj-Napoca, Cluj, 400015, Romania

Location

Related Publications (1)

  • Dobrean A, Poetar CR, Florean IS, Balan R, Andersson G. Transdiagnostic Internet-delivered intervention for children and adolescents with anxiety and depressive disorders: a randomized controlled trial. NPJ Digit Med. 2026 Jan 16. doi: 10.1038/s41746-026-02341-x. Online ahead of print.

MeSH Terms

Conditions

Anxiety DisordersPhobia, SocialGeneralized Anxiety DisorderPanic DisorderDepressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Mental DisordersPhobic DisordersDepressive DisorderMood DisordersBehavioral SymptomsBehavior

Study Officials

  • Anca Dobrean, Ph.D.

    Babeș-Bolyai University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 27, 2019

Study Start

January 25, 2020

Primary Completion

May 30, 2022

Study Completion

December 30, 2022

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations