Social AnxietyNCT02756507
Transdiagnostic REBT Prevention Program for Adolescents
A study testing video-based transdiagnostic REBT and Wait list in people with Social Anxiety and Major Depression Mild, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
Anxiety and depressive disorders are common in adolescents, however they are often unrecognized. Rational emotive behavioral therapy (REBT), a form of cognitive behavioral therapy (CBT) is efficient for children and adolescents. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety, Major Depression Mild, Panic Disorder
- What is being tested?
- video-based transdiagnostic REBT and Wait list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 381 participants
- Where
- 1 siteRomania
- Study dates
- Jun 2016to Jun 2018
- 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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preadolescents and adolescents will have ages between 12 and 17 years old;
- Are attending middle school or high-school;
- Adolescents have sufficient understanding of the Romanian language in order to complete assessments at all time points and to participate in the prevention program;
- Their parents have sufficient understanding of the Romanian language in order to sign the informed consent;
- Parents will sign the informed consent and adolescents will provide informed assent.
Who cannot join
- Age below 14 or above 17 years;
- No signed informed consent from parents;
- Adolescents will score high on suicidal ideation according to (1 item on the Depression subscale from Beck Youth Inventories);
- Not Romanian-speaking in order to understand the content of the prevention program and to complete the assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of a Video-based Transdiagnostic REBT Universal Prevention Program Delivered in a School Context for Internalizing Problems in Adolescents
Anxiety and depressive disorders are common in adolescents, however they are often unrecognized. Rational emotive behavioral therapy (REBT), a form of cognitive behavioral therapy (CBT) is efficient for children and adolescents. School settings are appropriate environments to deliver such interventions for vulnerable youths. Given youth's access and predilection to use technology, a video-based prevention program was developed. The present study aims to investigate the efficacy of a transdiagnostic REBT prevention program for internalizing symptoms in adolescents, implemented in a school setting.
Classes from different Romanian public schools will be randomized in either intervention or wait list group.
Read the detailed description
The prevention program will be group-based, delivered in 6 sessions, over 3 weeks.
Each of the six modules aimed a different component: Psychoeducation, Relaxation, Relationship between cognitive distortions/irrational beliefs and emotions, Cognitive restructuring, Exposure/ behavioral activation and problem solving, Maintenance of gainings. Despite specific activities, for each session a video cartoon on that subject will be viewed and discussed. Homework would be given at every session.
REBT prevention programs delivered in school settings represent ecological modalities to target vulnerable groups. Technology components added to traditional programs may lead to greater motivation and satisfaction with treatment.
Adolescents will complete assessments at four time-points: T1 (baseline), T2 (post-intervention), T3 (3 months follow-up) and T4 (12 months follow-up).
- Conditions
- Social Anxiety, Major Depression Mild, Panic Disorder, Specific Phobia, Generalized Anxiety Disorder
- Being tested
- video-based transdiagnostic REBT, Wait list
- Keywords
- anxiety symptoms, depression symptoms, internalizing symptoms
- Medical subject headings
- Panic Disorder, Phobia, Specific, Generalized Anxiety Disorder, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video-based transdiagnostic REBTBehavioural
The video-based transdiagnostic REBT consists of 6 sessions delivered in a group format.
Wait listBehavioural
Delayed intervention
| Study group | Role | What they receive |
|---|---|---|
| video-based transdiagnostic REBT | Experimental | Children and adolescents in the experimental group attend 6 modules of video-based transdiagnostic rational emotive behavioral therapy (REBT). Each of the six modules aimes a different component: Psychoeducation, Relaxation, Relationship between cognitive distortions/irrational beliefs and emotions, Cognitive restructuring, Exposure/ behavior activation and problem solving, Maintenance of gaining. Receives: Behavioral: video-based transdiagnostic REBT |
| wait list | Sham comparator | The wait-list is a delayed treatment condition. Receives: Behavioral: Wait list |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Multidimensional Anxiety Scale for Children (MASC; March, Parker, Sullivan, Stallings, & Conners, 1997)
anxiety symptoms
Measured: Change from baseline anxiety symptoms at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
Beck Depression Inventory for Youth subscale from the Beck Youth Inventories-Second edition for children and adolescents (Beck, 2005)
depressive symptoms
Measured: Change from baseline depressive symptoms at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
Secondary outcomes (5)
The Children's Automatic Thoughts Scale - Negative/Positive (CATS-N/P) (Hogendoorn et al., 2010)
maladaptive cognitions
Measured: Change from baseline maladaptive cognitions at 3 weeks post-intervention, 3 month follow up, 12 months follow-up
The Strengths and Difficulties Questionnaire (SDQ) (Goodman, 1997)
comorbid problems
Measured: Change from baseline comorbid problems at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
The Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents, The Revised Version - adolescent version (Kiddo-KINDL) (Ravens-Sieberer et al., 2001)
quality of life
Measured: Change from baseline quality of life at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
The Credibility/ Expectancy Questionnaire (Devilly & Borkovec, 2000)
Treatment expectancies
Measured: pre-intervention
The Client Satisfaction Scale (Vigerland et al., 2016)
Satisfaction with the intervention
Measured: post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018
- Study completionJun 2018
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 Social AnxietyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 381 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., Study director, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756507
- Sponsor's protocol ID
- PN-II-PT-PCCA-2011-3.1-1500
- Status last verified
- Feb 2023
- First submitted
- 25 Apr 2016
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be shared upon reasonable request.
Publications
Pasarelu CR, Dobrean A. A video-based transdiagnostic REBT universal prevention program for internalizing problems in adolescents: study protocol of a cluster randomized controlled trial. BMC Psychiatry. 2018 Apr 13;18(1):101. doi: 10.1186/s12888-018-1684-0.
PubMed 29653523
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Video-based Transdiagnostic REBT Universal Prevention Program Delivered in a School Context for Internalizing Problems in Adolescents
- ClinicalTrials.gov ID
- NCT02756507
- Acronym / sponsor ID
- PN-II-PT-PCCA-2011-3.1-1500
- Conditions
- Social Anxiety, Major Depression Mild, Panic Disorder, Specific Phobia, Generalized Anxiety Disorder
- Keywords
- anxiety symptoms, depression symptoms, internalizing symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 29 Apr 2016 (estimated)
- 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.
Anxiety and depressive disorders are common in adolescents, however they are often unrecognized. Rational emotive behavioral therapy (REBT), a form of cognitive behavioral therapy (CBT) is efficient for children and adolescents. School settings are appropriate environments to deliver such interventions for vulnerable youths. Given youth's access and predilection to use technology, a video-based prevention program was developed. The present study aims to investigate the efficacy of a transdiagnostic REBT prevention program for internalizing symptoms in adolescents, implemented in a school setting.
Classes from different Romanian public schools will be randomized in either intervention or wait list group.
Detailed description
The prevention program will be group-based, delivered in 6 sessions, over 3 weeks.
Each of the six modules aimed a different component: Psychoeducation, Relaxation, Relationship between cognitive distortions/irrational beliefs and emotions, Cognitive restructuring, Exposure/ behavioral activation and problem solving, Maintenance of gainings. Despite specific activities, for each session a video cartoon on that subject will be viewed and discussed. Homework would be given at every session.
REBT prevention programs delivered in school settings represent ecological modalities to target vulnerable groups. Technology components added to traditional programs may lead to greater motivation and satisfaction with treatment.
Adolescents will complete assessments at four time-points: T1 (baseline), T2 (post-intervention), T3 (3 months follow-up) and T4 (12 months follow-up).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| video-based transdiagnostic REBT | Experimental | Behavioral: video-based transdiagnostic REBTChildren and adolescents in the experimental group attend 6 modules of video-based transdiagnostic rational emotive behavioral therapy (REBT). Each of the six modules aimes a different component: Psychoeducation, Relaxation, Relationship between cognitive distortions/irrational beliefs and emotions, Cognitive restructuring, Exposure/ behavior activation and problem solving, Maintenance of gaining. |
| wait list | Sham comparator | Behavioral: Wait listThe wait-list is a delayed treatment condition. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Preadolescents and adolescents will have ages between 12 and 17 years old;
- Are attending middle school or high-school;
- Adolescents have sufficient understanding of the Romanian language in order to complete assessments at all time points and to participate in the prevention program;
- Their parents have sufficient understanding of the Romanian language in order to sign the informed consent;
- Parents will sign the informed consent and adolescents will provide informed assent.
Key exclusion criteria (4 listed)
- Age below 14 or above 17 years;
- No signed informed consent from parents;
- Adolescents will score high on suicidal ideation according to (1 item on the Depression subscale from Beck Youth Inventories);
- Not Romanian-speaking in order to understand the content of the prevention program and to complete the assessments.
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 |
|---|---|---|
| video-based transdiagnostic REBTThe video-based transdiagnostic REBT consists of 6 sessions delivered in a group format. | Behavioural | video-based transdiagnostic REBT |
| Wait listDelayed intervention | Behavioural | wait list |
Primary outcome
The Multidimensional Anxiety Scale for Children (MASC; March, Parker, Sullivan, Stallings, & Conners, 1997)
Time frame: Change from baseline anxiety symptoms at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
anxiety symptoms
Beck Depression Inventory for Youth subscale from the Beck Youth Inventories-Second edition for children and adolescents (Beck, 2005)
Time frame: Change from baseline depressive symptoms at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
depressive symptoms
5 secondary outcomes
The Children's Automatic Thoughts Scale - Negative/Positive (CATS-N/P) (Hogendoorn et al., 2010)
Time frame: Change from baseline maladaptive cognitions at 3 weeks post-intervention, 3 month follow up, 12 months follow-up
The Strengths and Difficulties Questionnaire (SDQ) (Goodman, 1997)
Time frame: Change from baseline comorbid problems at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
The Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents, The Revised Version - adolescent version (Kiddo-KINDL) (Ravens-Sieberer et al., 2001)
Time frame: Change from baseline quality of life at 3 weeks post-intervention, 3 months follow up, 12 months follow-up
The Credibility/ Expectancy Questionnaire (Devilly & Borkovec, 2000)
Time frame: pre-intervention
The Client Satisfaction Scale (Vigerland et al., 2016)
Time frame: post-intervention
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 8 Feb 2023.
- Derived from this study: PubMed 29653523Pasarelu CR, Dobrean A. A video-based transdiagnostic REBT universal prevention program for internalizing problems in adolescents: study protocol of a cluster randomized controlled trial. BMC Psychiatry. 2018 Apr 13;18(1):101. doi: 10.1186/s12888-018-1684-0.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request.
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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. study director
Babes-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 video-based transdiagnostic REBT and Wait list in people with Social Anxiety and Major Depression Mild, 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 8 Feb 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. Some participants in this study may receive a placebo. 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?
The Multidimensional Anxiety Scale for Children (MASC; March, Parker, Sullivan, Stallings, & Conners, 1997) (time frame: Change from baseline anxiety symptoms at 3 weeks post-intervention, 3 months follow up, 12 months follow-up). The study lists 2 primary outcomes in all. 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 NCT02756507, 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 8 Feb 2023.