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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04179526
Other study ID # PN-III-P4-ID-PCE-2016-0861
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 25, 2020
Est. completion date December 30, 2022

Study information

Verified date September 2023
Source Babes-Bolyai University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date December 30, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers No
Gender All
Age group 12 Years to 15 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Romania Babe?-Bolyai University Cluj-Napoca Cluj

Sponsors (1)

Lead Sponsor Collaborator
Babes-Bolyai University

Country where clinical trial is conducted

Romania, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Other Client Satisfaction Scale Satisfaction with the program. Higher scores indicate higher treatment satisfaction Immediately after the intervention (an expected average of 6 weeks)
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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