AdolescentsAcAdeMiCNCT04861116
AcAdeMiC: Acting With Acceptance, Mindfulness and Compassion to Overcome Test/Exam Anxiety
A study testing Intervention program for test anxiety in people with Adolescents and Test Anxiety, run by University of Coimbra at 1 site in Portugal.
Trial summary
Test Anxiety is a highly prevalent and impairing condition in adolescents (i.e., 9th to 12th grade students), significantly impacting on their mental health and well-being. Among Portuguese university students, test anxiety is the primary reason for seeking specialized psychological support, suggesting the importance… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Adolescents, Test Anxiety
- What is being tested?
- Intervention program for test anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Mar 2021to 31 Jul 2022
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- provision of written informed consent by participants and their legal guardians;
- presence of high levels of test anxiety, confirmed through self-report assessment and clinical interview;
- educational level from 9th to 12th grade;
- absence of Neurodevelopmental Disorders, except Specific Learning Disorders of mild severity;
- absence of any degree of cognitive decline or impairment;
- absence of any severe Depressive Disorder;
- absence of any other severe psychiatric condition (e.g., Obsessive-Compulsive Disorder, Bipolar Disorder, Psychotic Disorders);
- not being under treatment for a psychiatric condition.
Who cannot join
- no provision of written informed consent by participants and their legal guardians;
- absence of high levels of test anxiety, confirmed through self-report assessment;
- educational level below 9th and above 12th grade;
- presence of Neurodevelopmental Disorders, except Specific Learning Disorders of mild severity;
- presence of any degree of cognitive decline or impairment;
- presence of any severe Depressive Disorder;
- presence of any other severe psychiatric condition (e.g., Obsessive-Compulsive Disorder, Bipolar Disorder, Psychotic Disorders);
- being under treatment for a psychiatric condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AcAdeMiC: Acting With Acceptance, Mindfulness and Compassion to Overcome Test/Exam Anxiety - An ICT-based Psychotherapeutic Intervention for Adolescents
Test Anxiety is a highly prevalent and impairing condition in adolescents (i.e., 9th to 12th grade students), significantly impacting on their mental health and well-being. Among Portuguese university students, test anxiety is the primary reason for seeking specialized psychological support, suggesting the importance of early intervention.
Test anxiety associates to low self-compassion, acceptance and mindfulness, which have been increasingly acknowledged in literature as important processes to cultivate towards human experience and suffering, within intervention programs, particularly in adolescence, and in anxiety and fear of failure in academic settings.
Read more
These processes are covered and enhanced within comprehensive models and evidence-based therapies that adopt an integrative, contextual and biopsychosocial approach, such as Acceptance and Commitment Therapy (ACT), and Mindfulness-Based Cognitive Therapy (MBCT), as well as an evolutionary approach, such as Compassion Focused Therapy (CFT). These approaches focus on receiving internal events (e.g., thoughts, emotions, memories) in an accepting and compassionate way, as part of human experience, without changing them, while developing a sense of vitality, well-being and commitment to valued ends in life, instead of focusing solely or mainly on symptom reduction (although it is usually a consequent outcome).
However, there are no empirically validated therapeutic programs for adolescents with test anxiety promoting these processes combined.
ICT-based interventions are accessible, convenient, cost-effective and have been proved effective in reducing anxiety disorders' symptomatology. Even though there are some empirically validated online interventions for test anxiety in adolescents, having shown promising results, these were mainly self-help/module-based programs, without a clinician facilitating the intervention.
This project aims to develop and implement a 12-week ICT-based targeted, facilitated and manualized individual intervention for adolescent students, developing compassion, acceptance and mindfulness, in order to help improve test anxiety's regulation (and consequently symptom reduction), as well as increase general and school-related well-being, while promoting valued life action.
Read the detailed description
All ethical and deontological requirements are guarenteed in this study.
A sample of adolescent students (from 9th to 12th grade) is being online-recruited, through social media and contacts with Executive Boards of Portuguese secondary schools, private practices and study centers, advertising the study.
Parents/legal guardians are encouraged to contact the team. From this approach, parents/legal guardians and respective adolescents who demonstrate interest are explained the aims and procedures of the study and asked to sign a written consent form.
Adolescents are then assessed for eligibility through a test anxiety self-report measure and a clinical interview.
Eligible participants will be randomly assigned to either an experimental group, who will reveive the intervention (facilitated by licenced psychotherapists with training in contextual therapies and are familiar with the intervention protocol), or a waiting-list control group, who will have access to the intervention after the six-month follow-up assessment.
Both groups will complete a protocol with self-report measures, assessing psychopathology indicators, emotion regulation processes, and general and school-related well-being, in four different moments: at baseline (M0), immediatly after the intervention (M1), three months (M2) and six months (M3) after the intervention.
- Conditions
- Adolescents, Test Anxiety
- Being tested
- Intervention program for test anxiety
- Keywords
- test anxiety, adolescents, acceptance, mindfulness, compassion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention program for test anxietyBehavioural
Also called AcAdeMiC: Acting With Acceptance, Mindfulness and Compassion to Overcome Test/Exam Anxiety
12-week ICT-based manualized, targeted and facilitated individual intervention for adolescent students, that aims to promote compassion, acceptance and mindfulness, in order to help improve test anxiety's regulation (and consequently symptom reduction), as well as increase general and school-related well-being, while promoting valued life action.
| Study group | Role | What they receive |
|---|---|---|
| Intervention program for test anxiety | Experimental | 12 weekly ICT-delivered individual sessions. Receives: Behavioral: Intervention program for test anxiety |
| Control | No intervention | Waiting list that will have access to the intervention program after the 6-month follow-up assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test Anxiety
Reactions to Tests for Adolescents (RT-A). Participants rate the items on a Likert scale from 1 to 4. Lower scores indicate a better outcome
Measured: 6 months [From Baseline to 6 months follow-up]
Secondary outcomes (6)
General well-being
Mental Health Continuum - Short Form - for Youth (MHC-SF). Participants rate the items on a Likert scale from 0 to 5. Higher scores indicate a better outcome
Measured: 6 months [From Baseline to 6 months follow-up]
School-related well-being
School-related Well-Being Scale (SWBS). Participants rate the items on a Likert scale from 1 to 5. Higher scores indicate a better outcome
Measured: 6 months [From Baseline to 6 months follow-up]
Psychological flexibility in test situations
Test Anxiety Acceptance and Action Questionnaire for Adolescents (TA-AAQ-A). Participants rate the items on a Likert scale from 1 to 7. Higher scores indicate a better outcome
Measured: 6 months [From Baseline to 6 months follow-up]
General psychological flexibility
Avoidance and Fusion Questionnaire for Youth (AFQ-Y). Participants rate the items on a Likert scale from 0 to 4. Lower scores indicate a better outcome
Measured: 6 months [From Baseline to 6 months follow-up]
Mindfulness
Child and Adolescent Mindfulness Measure (CAMM). Participants rate the items on a Likert scale from 0 to 4. Higher scores indicate a better outcome
Measured: 6 months [From Baseline to 6 months follow-up]
Self-compassion
Self-Compassion Scale (SCS-A). Participants rate the items on a Likert scale from 1 to 5. Higher scores indicate a better outcome
Measured: 6 months [From Baseline to 6 months follow-up]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start15 Mar 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdolescentsStudies 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
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Principal investigator, Cláudia Pires, University of Coimbra
- Investigators
- Cláudia P. Pires, M.Sc., Principal investigator, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861116
- Sponsor's protocol ID
- SFRH/BD/143520/2019
- Acronym
- AcAdeMiC
- Status last verified
- Dec 2022
- First submitted
- 22 Apr 2021
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AcAdeMiC: Acting With Acceptance, Mindfulness and Compassion to Overcome Test/Exam Anxiety - An ICT-based Psychotherapeutic Intervention for Adolescents
- ClinicalTrials.gov ID
- NCT04861116
- Acronym / sponsor ID
- AcAdeMiC / SFRH/BD/143520/2019
- Conditions
- Adolescents, Test Anxiety
- Keywords
- test anxiety, adolescents, acceptance, mindfulness, compassion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 27 Apr 2021 (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.
Test Anxiety is a highly prevalent and impairing condition in adolescents (i.e., 9th to 12th grade students), significantly impacting on their mental health and well-being. Among Portuguese university students, test anxiety is the primary reason for seeking specialized psychological support, suggesting the importance of early intervention.
Test anxiety associates to low self-compassion, acceptance and mindfulness, which have been increasingly acknowledged in literature as important processes to cultivate towards human experience and suffering, within intervention programs, particularly in adolescence, and in anxiety and fear of failure in academic settings.
These processes are covered and enhanced within comprehensive models and evidence-based therapies that adopt an integrative, contextual and biopsychosocial approach, such as Acceptance and Commitment Therapy (ACT), and Mindfulness-Based Cognitive Therapy (MBCT), as well as an evolutionary approach, such as Compassion Focused Therapy (CFT). These approaches focus on receiving internal events (e.g., thoughts, emotions, memories) in an accepting and compassionate way, as part of human experience, without changing them, while developing a sense of vitality, well-being and commitment to valued ends in life, instead of focusing solely or mainly on symptom reduction (although it is usually a consequent outcome).
However, there are no empirically validated therapeutic programs for adolescents with test anxiety promoting these processes combined.
ICT-based interventions are accessible, convenient, cost-effective and have been proved effective in reducing anxiety disorders' symptomatology. Even though there are some empirically validated online interventions for test anxiety in adolescents, having shown promising results, these were mainly self-help/module-based programs, without a clinician facilitating the intervention.
This project aims to develop and implement a 12-week ICT-based targeted, facilitated and manualized individual intervention for adolescent students, developing compassion, acceptance and mindfulness, in order to help improve test anxiety's regulation (and consequently symptom reduction), as well as increase general and school-related well-being, while promoting valued life action.
Detailed description
All ethical and deontological requirements are guarenteed in this study.
A sample of adolescent students (from 9th to 12th grade) is being online-recruited, through social media and contacts with Executive Boards of Portuguese secondary schools, private practices and study centers, advertising the study.
Parents/legal guardians are encouraged to contact the team. From this approach, parents/legal guardians and respective adolescents who demonstrate interest are explained the aims and procedures of the study and asked to sign a written consent form.
Adolescents are then assessed for eligibility through a test anxiety self-report measure and a clinical interview.
Eligible participants will be randomly assigned to either an experimental group, who will reveive the intervention (facilitated by licenced psychotherapists with training in contextual therapies and are familiar with the intervention protocol), or a waiting-list control group, who will have access to the intervention after the six-month follow-up assessment.
Both groups will complete a protocol with self-report measures, assessing psychopathology indicators, emotion regulation processes, and general and school-related well-being, in four different moments: at baseline (M0), immediatly after the intervention (M1), three months (M2) and six months (M3) after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention program for test anxiety | Experimental | Behavioral: Intervention program for test anxiety12 weekly ICT-delivered individual sessions. |
| Control | No intervention | –Waiting list that will have access to the intervention program after the 6-month follow-up assessment. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- provision of written informed consent by participants and their legal guardians;
- presence of high levels of test anxiety, confirmed through self-report assessment and clinical interview;
- educational level from 9th to 12th grade;
- absence of Neurodevelopmental Disorders, except Specific Learning Disorders of mild severity;
- absence of any degree of cognitive decline or impairment;
Key exclusion criteria (8 listed)
- no provision of written informed consent by participants and their legal guardians;
- absence of high levels of test anxiety, confirmed through self-report assessment;
- educational level below 9th and above 12th grade;
- presence of Neurodevelopmental Disorders, except Specific Learning Disorders of mild severity;
- presence of any degree of cognitive decline or impairment;
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 |
|---|---|---|
| Intervention program for test anxietyAlso: AcAdeMiC: Acting With Acceptance, Mindfulness and Compassion to Overcome Test/Exam Anxiety12-week ICT-based manualized, targeted and facilitated individual intervention for adolescent students, that aims to promote compassion, acceptance and mindfulness, in order to help improve test anxiety's regulation (and consequently symptom reduction), as well as increase general and school-related well-being, while promoting valued life action. | Behavioural | Intervention program for test anxiety |
Primary outcome
Test Anxiety
Time frame: 6 months [From Baseline to 6 months follow-up]
Reactions to Tests for Adolescents (RT-A). Participants rate the items on a Likert scale from 1 to 4. Lower scores indicate a better outcome
6 secondary outcomes
General well-being
Time frame: 6 months [From Baseline to 6 months follow-up]
School-related well-being
Time frame: 6 months [From Baseline to 6 months follow-up]
Psychological flexibility in test situations
Time frame: 6 months [From Baseline to 6 months follow-up]
General psychological flexibility
Time frame: 6 months [From Baseline to 6 months follow-up]
Mindfulness
Time frame: 6 months [From Baseline to 6 months follow-up]
Self-compassion
Time frame: 6 months [From Baseline to 6 months follow-up]
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 2 Dec 2022.
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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.
Cláudia P. Pires, M.Sc. principal investigator
University of Coimbra
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 program for test anxiety in people with Adolescents and Test Anxiety, run by University of Coimbra 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 8 inclusion and 8 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 2 Dec 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: 6 months [From Baseline to 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 2 Dec 2022.