NCT05481099

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
519

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

July 27, 2022

Last Update Submit

July 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Worry

    12 weeks

  • Emotionality

    12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Cognitive-behavioural-based intervention combined with mindfulness, psychoeducation, and relaxation techniques

Behavioral: Intervention

Control

NO INTERVENTION

Care as usual

Interventions

InterventionBEHAVIORAL

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

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • th grade students; both students and parents provide written informed consent

You may not qualify if:

  • cognitive inability to answer the questionnaire and/or to participate in the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alves Martins High School

Viseu, Portugal

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research Department

Study Record Dates

First Submitted

July 27, 2022

First Posted

August 1, 2022

Study Start

December 1, 2019

Primary Completion

March 10, 2020

Study Completion

March 10, 2020

Last Updated

August 1, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations