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Clinical Trials/NCT03610542
NCT03610542
Not yet recruiting
Not Applicable

Reducing Clinical Anxiety in Adolescents Through Selective Intervention

Liverpool John Moores University0 sites400 target enrollmentSeptember 2021
ConditionsAnxiety

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Liverpool John Moores University
Enrollment
400
Primary Endpoint
Test Anxiety Inventory
Status
Not yet recruiting
Last Updated
5 years ago

Overview

Brief Summary

This study evaluates the clinical and cost effectiveness of test anxiety as a form of selective prevention for clinical anxiety. Participants will be randomly allocated to cognitive behavioural therapy without booster sessions, cognitive behavioural therapy with two booster sessions, or a no intervention control.

Detailed Description

Test anxiety affects a substantial proportion of adolescents, who show an increased risk of suicide, and of developing clinical anxiety and poor mental health. Externally resourced school-based cognitive behavioural therapy (CBT) interventions have been shown to be effective in treating test anxiety. Intervening in test anxiety, a sub-clinical anxiety, may prevent anxieties from developing into a clinical disorder. The primary outcomes are test anxiety, clinical anxiety, and wellbeing, measured at baseline, post-intervention, and 6 and 12-month follow-up. In addition, to identify treatment mechanisms additional measures are taken of uncertain control, metacognition, and emotional regulation.

Registry
clinicaltrials.gov
Start Date
September 2021
End Date
December 2024
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Participants are aged 14-16 years of age
  • In the upper 66th percentile of test anxiety scores

Exclusion Criteria

  • Participants are receiving other treatment for anxiety
  • Participants have a diagnosis of clinical anxiety depression or Attention Deficit Hyperactivity Disorder

Outcomes

Primary Outcomes

Test Anxiety Inventory

Time Frame: Change assessed over a 12 month period

The Test Anxiety Inventory is a 20 item measure measured on a 4-point scale (1 = Almost Never, 4 = Almost Always). Three scores are provided: Total (20 items), worry subscale (8 items) and emotionality (8 items). The total score range is 20-80 and the worry and emotionality subscale scores are 8-32. A higher score represents higher anxiety. This will administered 4 times over a 12 month period to assess change: Baseline, 6 weeks (immediate-post intervention), 6-month follow-up and 12 month follow-up.

Secondary Outcomes

  • Cognitive Emotion Regulation Questionnaire (short version)(Change assessed over a 12 month period)
  • The Metacognition Questionnaire(Change assessed over a 12 month period)
  • Motivation and Engagement Scale (uncertain control subscale)(Change assessed over a 12 month period)
  • Revised Children's Anxiety and Depression Scale (panic, generalized anxiety, and social anxiety subscales)(Change assessed over a 12 month period)
  • School-related Wellbeing Scale(Change assessed over a 12 month period)

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