Test AnxietyNCT05481099
Reducing Test Anxiety in High School Students
A study testing Intervention in people with Test Anxiety, run by Agrupamento de Centros de Saúde de Dão Lafões at 1 site in Portugal.
Trial summary
School-age test anxiety is an important risk factor for school performance. Notwithstanding, few studies seek to identify which strategies are effective in improving test anxiety. This study aimed to test whether a cognitive-behavioural intervention for high school students could significantly reduce test anxiety. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Test Anxiety
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 519 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Dec 2019to 10 Mar 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 10th grade students; both students and parents provide written informed consent
Who cannot join
- cognitive inability to answer the questionnaire and/or to participate in the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Cognitive Behavioural-based Intervention in Reducing Test Anxiety in High School Students: a Pilot Cluster Randomized Controlled Trial
School-age test anxiety is an important risk factor for school performance. Notwithstanding, few studies seek to identify which strategies are effective in improving test anxiety. This study aimed to test whether a cognitive-behavioural intervention for high school students could significantly reduce test anxiety.
A two-arm, cluster-randomized controlled, unblinded, parallel, trial was conducted. Participants were students of the 10th year of the Alves Martins High School in Viseu, Portugal. Students were randomized at class level to receive a cognitive-behavioural-based intervention combined with mindfulness, psychoeducation, and relaxation techniques, or to a control group with no intervention. Participants' anxiety levels were measured using the Test Anxiety Questionnaire. The analysis of the effect of the intervention was carried out on an intention-to-treat basis at the class level, using multilevel mixed effects models and Bayesian modelling.
- Conditions
- Test Anxiety
- Being tested
- Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Cognitive-behavioural-based intervention combined with mindfulness (attention focus), psychoeducation, and relaxation techniques (short version of Jacobson's progressive relaxation, breathing exercises)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Cognitive-behavioural-based intervention combined with mindfulness, psychoeducation, and relaxation techniques Receives: Behavioral: Intervention |
| Control | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test anxiety
Participants' test anxiety will be assessed using the Test Anxiety Questionnaire. Scores on the questionnaire range from 10 to 50 points. Higher scores mean higher anxiety levels.
Measured: 12 weeks
Secondary outcomes (2)
Worry
Participants' worry will be assessed using the Worry subscale (items 1-5) of the Test Anxiety Questionnaire. Scores on the questionnaire range from 5 to 25 points. Higher scores mean higher worry-related anxiety levels.
Measured: 12 weeks
Emotionality
Participants' emotionality will be assessed using the Emotionality subscale (items 6-10) of the Test Anxiety Questionnaire. Scores on the questionnaire range from 5 to 25 points. Higher scores mean higher emotionality-related anxiety levels.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Dec 2019
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
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 Test 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 519 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agrupamento de Centros de Saúde de Dão Lafões
- Sponsor type
- University, hospital or other
- Collaborators
- Casa de Saúde São Mateus - Hospital
- Responsible party
- Principal investigator, Frederico Rosário, MD, PhD, Agrupamento de Centros de Saúde de Dão Lafões
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481099
- Sponsor's protocol ID
- Anxiety-2020
- Status last verified
- Jul 2022
- First submitted
- 27 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lopes D, Ferrao A, Matanca AF, Almeida C, Rosario F, Santos J, Santos MI. [A Cognitive Behavioural-Based Intervention in Reducing Test Anxiety in High School Students: A Pilot Cluster Randomized Controlled Trial]. Acta Med Port. 2024 Feb 5;37(3):163-171. doi: 10.20344/amp.18876. Epub 2023 Mar 20. Portuguese.
PubMed 36939679
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Cognitive Behavioural-based Intervention in Reducing Test Anxiety in High School Students: a Pilot Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05481099
- Acronym / sponsor ID
- Anxiety-2020
- Conditions
- Test Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 519 participants (actual)
- Lead sponsor
- Agrupamento de Centros de Saúde de Dão LafõesUniversity, hospital or other
- Collaborators
- Casa de Saúde São Mateus - Hospital
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 1 Aug 2022 (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.
School-age test anxiety is an important risk factor for school performance. Notwithstanding, few studies seek to identify which strategies are effective in improving test anxiety. This study aimed to test whether a cognitive-behavioural intervention for high school students could significantly reduce test anxiety.
A two-arm, cluster-randomized controlled, unblinded, parallel, trial was conducted. Participants were students of the 10th year of the Alves Martins High School in Viseu, Portugal. Students were randomized at class level to receive a cognitive-behavioural-based intervention combined with mindfulness, psychoeducation, and relaxation techniques, or to a control group with no intervention. Participants' anxiety levels were measured using the Test Anxiety Questionnaire. The analysis of the effect of the intervention was carried out on an intention-to-treat basis at the class level, using multilevel mixed effects models and Bayesian modelling.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionCognitive-behavioural-based intervention combined with mindfulness, psychoeducation, and relaxation techniques |
| Control | No intervention | –Care as usual |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 10th grade students; both students and parents provide written informed consent
Key exclusion criteria (1 listed)
- cognitive inability to answer the questionnaire and/or to participate in the intervention
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 |
|---|---|---|
| InterventionCognitive-behavioural-based intervention combined with mindfulness (attention focus), psychoeducation, and relaxation techniques (short version of Jacobson's progressive relaxation, breathing exercises) | Behavioural | Intervention |
Primary outcome
Test anxiety
Time frame: 12 weeks
Participants' test anxiety will be assessed using the Test Anxiety Questionnaire. Scores on the questionnaire range from 10 to 50 points. Higher scores mean higher anxiety levels.
2 secondary outcomes
Worry
Time frame: 12 weeks
Emotionality
Time frame: 12 weeks
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 1 Aug 2022.
- Derived from this study: PubMed 36939679Lopes D, Ferrao A, Matanca AF, Almeida C, Rosario F, Santos J, Santos MI. [A Cognitive Behavioural-Based Intervention in Reducing Test Anxiety in High School Students: A Pilot Cluster Randomized Controlled Trial]. Acta Med Port. 2024 Feb 5;37(3):163-171. doi: 10.20344/amp.18876. Epub 2023 Mar 20. Portuguese.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Test Anxiety, run by Agrupamento de Centros de Saúde de Dão Lafões at 1 site in Portugal.
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 1 inclusion and 1 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 1 Aug 2022. 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 Portugal. 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?
Test anxiety (time frame: 12 weeks). 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 NCT05481099, 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 1 Aug 2022.