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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05481099
Other study ID # Anxiety-2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2019
Est. completion date March 10, 2020

Study information

Verified date July 2022
Source Agrupamento de Centros de Saúde de Dão Lafões
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 519
Est. completion date March 10, 2020
Est. primary completion date March 10, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 10th grade students; both students and parents provide written informed consent Exclusion Criteria: - cognitive inability to answer the questionnaire and/or to participate in the intervention

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intervention
Cognitive-behavioural-based intervention combined with mindfulness (attention focus), psychoeducation, and relaxation techniques (short version of Jacobson's progressive relaxation, breathing exercises)

Locations

Country Name City State
Portugal Alves Martins High School Viseu

Sponsors (2)

Lead Sponsor Collaborator
Agrupamento de Centros de Saúde de Dão Lafões Casa de Saúde São Mateus - Hospital

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 weeks
Secondary 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. 12 weeks
Secondary 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. 12 weeks
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