NCT03610542

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable anxiety

Status
unknown

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

First Submitted

Initial submission to the registry

July 16, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
3.1 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

1.7 years

First QC Date

July 16, 2018

Last Update Submit

September 2, 2020

Conditions

Keywords

Test AnxietyWellbeing

Outcome Measures

Primary Outcomes (1)

  • Test Anxiety Inventory

    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.

    Change assessed over a 12 month period

Secondary Outcomes (5)

  • The Metacognition Questionnaire

    Change assessed over a 12 month period

  • Cognitive Emotion Regulation Questionnaire (short version)

    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

Study Arms (3)

Cognitive Behaviour Therapy

EXPERIMENTAL

Cognitive behaviour therapy conducted in groups of 6-8 persons.One forty-five minute session per week for 6 weeks: Triggers for anxiety, identifying and challenging negative thoughts, relaxation, overcoming avoidance, and goal setting.

Behavioral: Triggers for anxietyBehavioral: Identifying and challenging negative thoughtsBehavioral: RelaxationBehavioral: Goal SettingBehavioral: Overcoming avoidance

Cognitive Behaviour Therapy with 2 Booster Sessions

EXPERIMENTAL

Cognitive behaviour therapy conducted in groups of 6-8 persons.One forty-five minute session per week for 6 weeks: Triggers for anxiety, identifying and challenging negative thoughts, relaxation, overcoming avoidance, and goal setting. 2 booster sessions (forty-five minutes each) will be provided at three and nine months. Each session will recap the content of the initial 6 sessions.

Behavioral: Triggers for anxietyBehavioral: Identifying and challenging negative thoughtsBehavioral: RelaxationBehavioral: Goal SettingBehavioral: Overcoming avoidance

Control

NO INTERVENTION

This is a no intervention control arm

Interventions

Students learn about different triggers for anxiety, what the signs and indicators of anxiety are, and identify their own triggers for anxiety

Also known as: STEPS
Cognitive Behaviour TherapyCognitive Behaviour Therapy with 2 Booster Sessions

Students learn about the types of unrealistic thoughts that underpin anxiety and how anxiety can be reduced with more realistic thoughts. Students identify their own unrealistic thoughts that contribute to anxiety and what more realistic thoughts can be used.

Also known as: STEPS
Cognitive Behaviour TherapyCognitive Behaviour Therapy with 2 Booster Sessions
RelaxationBEHAVIORAL

Students are taught to relax through (1) breathing exercises, (2) progressive muscle relaxation, and (3) imagery. Student practice these techniques.

Also known as: STEPS
Cognitive Behaviour TherapyCognitive Behaviour Therapy with 2 Booster Sessions
Goal SettingBEHAVIORAL

Students learn how to set goals, monitor goal progress, and check when goals have been achieved. Students then identify their own goals.

Also known as: STEPS
Cognitive Behaviour TherapyCognitive Behaviour Therapy with 2 Booster Sessions

Students identify ways that they avoid anxiety-provoking situations (e.g., procrastinating exam study). Students develop plans for exposure to anxiety-provoking situations and learn study strategies to build confidence.

Also known as: STEPS
Cognitive Behaviour TherapyCognitive Behaviour Therapy with 2 Booster Sessions

Eligibility Criteria

Age14 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Precipitating FactorsOrganizational Objectives

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

CausalityEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthOrganization and AdministrationHealth Services Administration

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Sequentially numbered opaque sealed envelopes will be used to conceal allocation. Envelopes will be prepared by a member of the research team and opened by participants.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly allocated to one of three conditions: Cognitive behavioural therapy with no booster sessions, Cognitive behavioural therapy with 2 booster sessions or a no intervention control arm.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2018

First Posted

August 1, 2018

Study Start

September 1, 2021

Primary Completion

June 1, 2023

Study Completion

December 1, 2024

Last Updated

September 4, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

A curated dataset will be uploaded to the Mendeley Open Data repository and assigned a doi that can be linked to all published articles via Science Direct

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be uploaded in December 2022 and remain available permanently
Access Criteria
Registration with Mendeley Open Data or Science Direct