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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04861116
Other study ID # SFRH/BD/143520/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2021
Est. completion date July 31, 2022

Study information

Verified date December 2022
Source University of Coimbra
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date July 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender All
Age group 13 Years to 18 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intervention program for test 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.

Locations

Country Name City State
Portugal University of Coimbra Coimbra

Sponsors (3)

Lead Sponsor Collaborator
University of Coimbra CINEICC - Center for Research in Neuropsychology and Cognitive Behavioral Intervention, Fundação para a Ciência e a Tecnologia

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Other Depression, anxiety and stress Depression Anxiety and Stress Scales (DASS-21). Participants rate the items on a Likert scale from 0 to 3. Lower scores indicate a better outcome 6 months [From Baseline to 6 months follow-up]
Other Self-criticism Forms of Self-Criticizing/attacking and self-Reassuring Scale (FSCRS-A). Participants rate the items on a Likert scale from 0 to 4. Lower scores indicate a better outcome 6 months [From Baseline to 6 months follow-up]
Other Shame External and Internal Shame Scale for adolescents (EISS-A). Participants rate the items on a Likert scale from 0 to 4. Lower scores indicate a better outcome 6 months [From Baseline to 6 months follow-up]
Primary 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 6 months [From Baseline to 6 months follow-up]
Secondary 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 6 months [From Baseline to 6 months follow-up]
Secondary 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 6 months [From Baseline to 6 months follow-up]
Secondary 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 6 months [From Baseline to 6 months follow-up]
Secondary 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 6 months [From Baseline to 6 months follow-up]
Secondary 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 6 months [From Baseline to 6 months follow-up]
Secondary 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 6 months [From Baseline to 6 months follow-up]
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