NCT04861116

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

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

March 15, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 22, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

December 2, 2022

Status Verified

December 1, 2022

Enrollment Period

1.4 years

First QC Date

April 22, 2021

Last Update Submit

December 1, 2022

Conditions

Keywords

test anxietyadolescentsacceptancemindfulnesscompassion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • General well-being

    6 months [From Baseline to 6 months follow-up]

  • School-related well-being

    6 months [From Baseline to 6 months follow-up]

  • Psychological flexibility in test situations

    6 months [From Baseline to 6 months follow-up]

  • General psychological flexibility

    6 months [From Baseline to 6 months follow-up]

  • Mindfulness

    6 months [From Baseline to 6 months follow-up]

  • +1 more secondary outcomes

Other Outcomes (3)

  • Depression, anxiety and stress

    6 months [From Baseline to 6 months follow-up]

  • Self-criticism

    6 months [From Baseline to 6 months follow-up]

  • Shame

    6 months [From Baseline to 6 months follow-up]

Study Arms (2)

Intervention program for test anxiety

EXPERIMENTAL

12 weekly ICT-delivered individual sessions.

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.

Interventions

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.

Also known as: AcAdeMiC: Acting With Acceptance, Mindfulness and Compassion to Overcome Test/Exam Anxiety
Intervention program for test anxiety

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Coimbra

Coimbra, 3000-115, Portugal

Location

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Cláudia P. Pires, M.Sc.

    University of Coimbra

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 22, 2021

First Posted

April 27, 2021

Study Start

March 15, 2021

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

December 2, 2022

Record last verified: 2022-12

Locations