Anxiety DisordersNEURO4CNCT06724666
Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression
A study testing Transdiagnostic Internet-delivered intervention in people with Anxiety Disorders and Depressive Disorder, run by Babes-Bolyai University at 2 sites in Romania.
Trial summary
The goal of this clinical trial is to test the efficacy of a transdiagnostic Internet-delivered interventions for Romanian adolescents with anxiety and/ or depression. The main questions it aims to answer are: What is the clinical efficacy of the Internet-delivered intervention? How accurate is the prediction model in… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Anxiety Disorders, Depressive Disorder, Social Anxiety Disorder
- What is being tested?
- Transdiagnostic Internet-delivered intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 2 sitesRomania
- Study dates
- 1 Apr 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- elevated symptoms of anxiety or depression/ internalizing problems (T score> 60) at intake (based on Youth self-report completed by adolescents)
- primary diagnosis of an anxiety/depressive disorder based on DSM-5 criteria according to ADIS-5-C/P interview
- age 13-17
- able to read and understand Romanian language
- Currently unmedicated or on stable and adequate doses of medication for at least 6 weeks before treatment onset
- Internet access
Who cannot join
- severe mental disorder (psychosis, severe depression, bipolar disorder, based on clinical interview)
- any condition that interferes with the protocol implementation (e.g., physical illness or sensory impairment that interferes with behavioral tasks such as exposure, behavioral activation, unavailable for the next 3 months),
- active suicidal ideation (assessed by child psychiatrist during clinical interview) in the last month
- currently following CBT/ psychotherapy for anxiety/depression, in the last 6 months
- fMRI incompatible (based on safety questionnaire)
- Being diagnosed with an intellectual disability, pervasive developmental disorder, an alcohol and/or substance dependence disorder, reading disabilities (based on clinical interview).
- Current treatment with benzodiazepines
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Romania2 sites, 2 recruiting
- Not yet recruiting
Babes-Bolyai University
Cluj-Napoca, 400015
Costina R Poetar, Ph.D, + 40743589465, costinapoetar@psychology.ro
Costina R Poetar, Ph.D
- Recruiting
Babeș-Bolyai University
Cluj-Napoca, 400015
About this study
The goal of this clinical trial is to test the efficacy of a transdiagnostic Internet-delivered interventions for Romanian adolescents with anxiety and/ or depression. The main questions it aims to answer are:
- What is the clinical efficacy of the Internet-delivered intervention?
- How accurate is the prediction model in predicting who will respond to treatment? Participants will undergo non-invasive fMRI to measure variability in brain signal as a proxy of the neural systems' adaptability before receiving the intervention, then they will be allocated either to the Internet-delivered intervention or control group.
Read the detailed description
To the best of investigators' knowledge, this is the first clinical trial conducted with adolescents diagnosed with anxiety/and or depressive disorders that tests the accuracy of a prediction model based on fMRI to investigate participants' response to a transdiagnostic Internet-delivered intervention.
- Conditions
- Anxiety Disorders, Depressive Disorder, Social Anxiety Disorder, Major Depressive Disorder, Dysthymia, Generalized Anxiety Disorder
- Being tested
- Transdiagnostic Internet-delivered intervention
- Keywords
- Internet-delivered intervention, transdiagnostic, adolescents, internalizing, anxiety, depression
- Medical subject headings
- Anxiety Disorders, Depressive Disorder, Phobia, Social, Depressive Disorder, Major, Dysthymic Disorder, Generalized Anxiety Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiagnostic Internet-delivered interventionBehavioural
The intervention consists of 8 modules based on Rational emotive therapy, delivered via 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Transdiagnostic Internet-delivered intervention | Experimental | The intervention consists of 8 modules delivered over 8 weeks. It is based on Rational Emotive Behavioral Therapy (REBT). Receives: Behavioral: Transdiagnostic Internet-delivered intervention |
| Control group | No intervention | Participants in the control group are a delayed intervention group (waiting list control). They will access the intervention after 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internalizing problems
Change from baseline in internalizing problems. Revised Children's Anxiety and Depression Scale (RCADS) completed by adolescents.
Measured: baseline, after 8 weeks of intervention, 6 months follow-up
Secondary outcomes (16)
Clinical diagnosis
Change in DSM-5 Anxiety and Depressive Disorder Diagnoses in Accordance with Anxiety Disorders Interview Schedule for the DSM-5, Child and Parent Versions (ADIS-5-C/P) Clinical Diagnosis
Measured: administered pre-baseline, post-baseline (after 8 week waitlist period), after 8 weeks of intervention
Global functioning
Children's Global Assessment Scale (C-GAS)
Measured: baseline, after 8 weeks of intervention, 6 months follow-up
Severity
Clinical Global Impression Scale - Severity
Measured: baseline, after 8 weeks of intervention, 6 months follow-up
Improvement
Clinical Global Impression Scale - Improvement
Measured: after 8 weeks of intervention, 6 months follow-up
Comorbid problems
Subscales of the Revised Children's Anxiety and Depression Scale (RCADS) completed by adolescents
Measured: baseline, after 8 weeks of intervention, 6 month follow-up
Life satisfaction
SWLS-C: Satisfaction with Life Scale for Children
Measured: baseline, after 8 weeks of intervention, 6 months follow-up
Satisfaction with the Internet-delivered intervention
Client Satisfaction Questionnaire (CSQ-8)
Measured: after 8 weeks of intervention
Working alliance
Working alliance scale for Internet interventions
Measured: after 8 weeks of intervention
Automatic thoughts
Automatic thoughts questionnaire
Measured: baseline, after 8 weeks of intervention, 6 month follow-up
Credibility and expectations
Credibility and expectations questionnaire
Measured: week 2
Credibility and expectations based on primary outcome measure
Credibility and expectations based on primary outcome scale
Measured: baseline
Anxiety and depressive symptoms
PHQ4
Measured: baseline, at each 2 weeks during treatment duration, after 8 weeks of intervention, 6 months follow-up
Avoidance
CAMS
Measured: baseline, after 8 weeks of intervention, 6 month follow-up
Parental distress
DASS-21
Measured: baseline
Adolescent anxiety and depressive symptoms as reported by parents
RCADS-47 parent report
Measured: baseline, after 8 weeks of intervention, 6 month follow-up
Parental accommodations
Family accommodation scale - parent report
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Apr 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Costina-Ruxandra Poetar, Babes-Bolyai University
- Investigators
- Costina Poetar, PhD, Study chair, Babeș-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724666
- Sponsor's protocol ID
- PNRR-III-C9-2022-I8-CF278
- Acronym
- NEURO4C
- Status last verified
- Apr 2025
- First submitted
- 2 Dec 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be will be shared after the publication of the results.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression
- ClinicalTrials.gov ID
- NCT06724666
- Acronym / sponsor ID
- NEURO4C / PNRR-III-C9-2022-I8-CF278
- Conditions
- Anxiety Disorders, Depressive Disorder, Social Anxiety Disorder, Major Depressive Disorder, Dysthymia, Generalized Anxiety Disorder
- Keywords
- Internet-delivered intervention, transdiagnostic, adolescents, internalizing, anxiety, depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 9 Dec 2024 (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.
The goal of this clinical trial is to test the efficacy of a transdiagnostic Internet-delivered interventions for Romanian adolescents with anxiety and/ or depression. The main questions it aims to answer are:
- What is the clinical efficacy of the Internet-delivered intervention?
- How accurate is the prediction model in predicting who will respond to treatment? Participants will undergo non-invasive fMRI to measure variability in brain signal as a proxy of the neural systems' adaptability before receiving the intervention, then they will be allocated either to the Internet-delivered intervention or control group.
Detailed description
To the best of investigators' knowledge, this is the first clinical trial conducted with adolescents diagnosed with anxiety/and or depressive disorders that tests the accuracy of a prediction model based on fMRI to investigate participants' response to a transdiagnostic Internet-delivered intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transdiagnostic Internet-delivered intervention | Experimental | Behavioral: Transdiagnostic Internet-delivered interventionThe intervention consists of 8 modules delivered over 8 weeks. It is based on Rational Emotive Behavioral Therapy (REBT). |
| Control group | No intervention | –Participants in the control group are a delayed intervention group (waiting list control). They will access the intervention after 8 weeks. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- elevated symptoms of anxiety or depression/ internalizing problems (T score> 60) at intake (based on Youth self-report completed by adolescents)
- primary diagnosis of an anxiety/depressive disorder based on DSM-5 criteria according to ADIS-5-C/P interview
- age 13-17
- able to read and understand Romanian language
- Currently unmedicated or on stable and adequate doses of medication for at least 6 weeks before treatment onset
Key exclusion criteria (7 listed)
- severe mental disorder (psychosis, severe depression, bipolar disorder, based on clinical interview)
- any condition that interferes with the protocol implementation (e.g., physical illness or sensory impairment that interferes with behavioral tasks such as exposure, behavioral activation, unavailable for the next 3 months),
- active suicidal ideation (assessed by child psychiatrist during clinical interview) in the last month
- currently following CBT/ psychotherapy for anxiety/depression, in the last 6 months
- fMRI incompatible (based on safety questionnaire)
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 interventionThe intervention consists of 8 modules based on Rational emotive therapy, delivered via 8 weeks. | Behavioural | Transdiagnostic Internet-delivered intervention |
Primary outcome
Internalizing problems
Time frame: baseline, after 8 weeks of intervention, 6 months follow-up
Change from baseline in internalizing problems. Revised Children's Anxiety and Depression Scale (RCADS) completed by adolescents.
16 secondary outcomes
Clinical diagnosis
Time frame: administered pre-baseline, post-baseline (after 8 week waitlist period), after 8 weeks of intervention
Global functioning
Time frame: baseline, after 8 weeks of intervention, 6 months follow-up
Severity
Time frame: baseline, after 8 weeks of intervention, 6 months follow-up
Improvement
Time frame: after 8 weeks of intervention, 6 months follow-up
Comorbid problems
Time frame: baseline, after 8 weeks of intervention, 6 month follow-up
Life satisfaction
Time frame: baseline, after 8 weeks of intervention, 6 months follow-up
Satisfaction with the Internet-delivered intervention
Time frame: after 8 weeks of intervention
Working alliance
Time frame: after 8 weeks of intervention
Automatic thoughts
Time frame: baseline, after 8 weeks of intervention, 6 month follow-up
Credibility and expectations
Time frame: week 2
Credibility and expectations based on primary outcome measure
Time frame: baseline
Anxiety and depressive symptoms
Time frame: baseline, at each 2 weeks during treatment duration, after 8 weeks of intervention, 6 months follow-up
Avoidance
Time frame: baseline, after 8 weeks of intervention, 6 month follow-up
Parental distress
Time frame: baseline
Adolescent anxiety and depressive symptoms as reported by parents
Time frame: baseline, after 8 weeks of intervention, 6 month follow-up
Parental accommodations
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be will be shared after the publication of the results.
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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.
Costina Poetar, PhD study chair
Babeș-Bolyai University
2 sites 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 intervention in people with Anxiety Disorders and Depressive Disorder, run by Babes-Bolyai University at 2 sites 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristoffer Mansson, PhD (+46705803267, nils.mansson@ubbcluj.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internalizing problems (time frame: baseline, after 8 weeks of intervention, 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2025.