Anxiety DisordersREBTonAdNCT04179526
Transdiagnostic Internet-delivered REBT Intervention for Adolescents' Internalizing Problems
A study testing Transdiagnostic Internet-delivered REBT in people with Anxiety Disorders and Social Anxiety Disorder, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
To investigate the efficacy and mechanisms of change of an Internet-delivered transdiagnostic REBT intervention for adolescents with internalizing problems. Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Anxiety Disorders, Social Anxiety Disorder, Generalized Anxiety Disorder
- What is being tested?
- Transdiagnostic Internet-delivered REBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteRomania
- Study dates
- 25 Jan 2020to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety Disorders, Social Anxiety Disorder, Generalized Anxiety Disorder, Panic Disorder, Persistent Depressive Disorder, Major Depressive Disorder
- Being tested
- Transdiagnostic Internet-delivered REBT
- Keywords
- transdiagnostic, anxiety, depression, REBT, adolescents, Internet intervention
- Medical subject headings
- Anxiety Disorders, Phobia, Social, Generalized Anxiety Disorder, Panic Disorder, Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiagnostic Internet-delivered REBTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Change in negative automatic thoughts from baseline. Higher scores indicating higher levels of negative automatic thoughts.
Measured: 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)
Change in irrational beliefs from baseline. Higher scores indicate higher levels of irrational beliefs.
Measured: 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)
Change in quality of life from baseline from baseline. Higher scores indicate higher levels of quality of life.
Measured: Baseline, Immediately after the intervention (an expected average of 6 weeks), 6-month follow-up
The Adolescent Peer Relations Instrument (APRI; Parada, 2000)
Change in bullying victimization from baseline. Higher scores indicate higher levels of peer victimization.
Measured: 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
Diagnostic interview for anxiety disorders and/or depressive disorders
Measured: Baseline, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start25 Jan 2020
- Primary completion30 May 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anca Dobrean, Babes-Bolyai University
- Investigators
- Anca Dobrean, Ph.D., Principal investigator, Babeș-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179526
- Sponsor's protocol ID
- PN-III-P4-ID-PCE-2016-0861
- Acronym
- REBTonAd
- Status last verified
- Sep 2023
- First submitted
- 14 Nov 2019
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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;9(1):156. doi: 10.1038/s41746-026-02341-x.
PubMed 41545507
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Mechanisms of Change of a Transdiagnostic Internet-delivered REBT Intervention for Adolescents With Internalizing Problems: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04179526
- Acronym / sponsor ID
- REBTonAd / PN-III-P4-ID-PCE-2016-0861
- Conditions
- Anxiety Disorders, Social Anxiety Disorder, Generalized Anxiety Disorder, Panic Disorder, Persistent Depressive Disorder, Major Depressive Disorder
- Keywords
- transdiagnostic, anxiety, depression, REBT, adolescents, Internet intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Study start
- 25 Jan 2020 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transdiagnostic Internet-delivered REBT | Experimental | Behavioral: Transdiagnostic Internet-delivered REBTProtocol 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) |
| 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. |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdiagnostic Internet-delivered REBTThe 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. | Behavioural | Transdiagnostic Internet-delivered REBT |
Primary outcome
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.
5 secondary outcomes
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
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
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
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
Principal diagnosis based on Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
Time frame: Baseline, 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 41545507Dobrean 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;9(1):156. doi: 10.1038/s41746-026-02341-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anca Dobrean, Ph.D. principal investigator
Babeș-Bolyai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdiagnostic Internet-delivered REBT in people with Anxiety Disorders and Social Anxiety Disorder, run by Babes-Bolyai University at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04179526, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.