AnxietyNCT03610542
School-based Interventions for Test Anxiety in Adolescents
A study testing Triggers for anxiety, Identifying and challenging negative thoughts and Relaxation in people with Anxiety, run by Liverpool John Moores University.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Triggers for anxiety, Identifying and challenging negative thoughts and Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Dec 2024
- 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 14 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants are aged 14-16 years of age
- In the upper 66th percentile of test anxiety scores
Who cannot join
- Participants are receiving other treatment for anxiety
- Participants have a diagnosis of clinical anxiety depression or Attention Deficit Hyperactivity Disorder
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Reducing Clinical Anxiety in Adolescents Through Selective Intervention
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Triggers for anxiety, Identifying and challenging negative thoughts, Relaxation, Goal Setting, Overcoming avoidance
- Keywords
- Test Anxiety, Wellbeing
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triggers for anxietyBehavioural
Also called STEPS
Students learn about different triggers for anxiety, what the signs and indicators of anxiety are, and identify their own triggers for anxiety
Identifying and challenging negative thoughtsBehavioural
Also called STEPS
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.
RelaxationBehavioural
Also called STEPS
Students are taught to relax through (1) breathing exercises, (2) progressive muscle relaxation, and (3) imagery. Student practice these techniques.
Goal SettingBehavioural
Also called STEPS
Students learn how to set goals, monitor goal progress, and check when goals have been achieved. Students then identify their own goals.
Overcoming avoidanceBehavioural
Also called STEPS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Triggers for anxiety; Behavioral: Identifying and challenging negative thoughts; Behavioral: Relaxation; Behavioral: Goal Setting; Behavioral: 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. Receives: Behavioral: Triggers for anxiety; Behavioral: Identifying and challenging negative thoughts; Behavioral: Relaxation; Behavioral: Goal Setting; Behavioral: Overcoming avoidance |
| Control | No intervention | This is a no intervention control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change assessed over a 12 month period
Secondary outcomes (5)
The Metacognition Questionnaire
The Metacognition Questionnaire is a 30-item questionnaire that consists of six subscales: Cognitive confidence, positive beliefs, cognitive self-consciousness, uncontrollability and danger, and need to control thoughts. Each subscale comprises of 5 items and uses a 4-point scale (1 = do not agree, 4 = agree very much) and the range of scores for each subscale is 5-20. A higher score represents negative beliefs about worry. These subscales 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.
Measured: Change assessed over a 12 month period
Cognitive Emotion Regulation Questionnaire (short version)
The Cognitive Emotion Regulation Questionnaire has 18 items and consists of nine subscales: Self-blame, other-blame, rumination, catastrophizing, positive refocusing, planning, positive reappraisal, putting into perspective and acceptance. Each subscale comprises of 2 items and uses a 5-point scale (1 = almost never, 5 = almost always) and the range of scores for each subscale is 2-10. A higher score represents greater use of cognitive coping strategies. These subscales 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.
Measured: Change assessed over a 12 month period
Motivation and Engagement Scale (uncertain control subscale)
4 items measure measured on a 7-point scale (1 = strongly disagree, 7 = strongly agree) resulting in a score from 7-28. A higher score represents greater uncertain control. This subscale 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.
Measured: Change assessed over a 12 month period
Revised Children's Anxiety and Depression Scale (panic, generalized anxiety, and social anxiety subscales)
The generalised anxiety subscale (6 items), panic subscale (9 items), and social anxiety subscale (9 items) of the Revised Children's Anxiety and Depression Scale, are all measured on a 4-point scale (0 = Never, 3 = Always). The range of scores for the generalised anxiety subscale is 0-18, the panic subscale is 0-27, and the social anxiety subscale is 0-27. A higher score represents higher anxiety. These subscales 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.
Measured: Change assessed over a 12 month period
School-related Wellbeing Scale
6 items measured on a 5-point scale (1 = Strongly Disagree, 5 = Strongly Agree) resulting in a score from 6-30. A higher score represents higher school-related wellbeing. These subscales 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.
Measured: Change assessed over a 12 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study startSep 2021 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Manchester University, Leeds University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610542
- Sponsor's protocol ID
- EHC0341
- Status last verified
- Sep 2020
- First submitted
- 16 Jul 2018
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Clinical Anxiety in Adolescents Through Selective Intervention
- ClinicalTrials.gov ID
- NCT03610542
- Acronym / sponsor ID
- EHC0341
- Conditions
- Anxiety
- Keywords
- Test Anxiety, Wellbeing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Wellcome Trust, Manchester University, Leeds University
- Study start
- Sep 2021 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Aug 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behaviour Therapy | Experimental | Behavioral: Triggers for anxiety, Behavioral: Identifying and challenging negative thoughts, Behavioral: Relaxation, Behavioral: Goal Setting, Behavioral: Overcoming avoidanceCognitive 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. |
| Cognitive Behaviour Therapy with 2 Booster Sessions | Experimental | Behavioral: Triggers for anxiety, Behavioral: Identifying and challenging negative thoughts, Behavioral: Relaxation, Behavioral: Goal Setting, Behavioral: Overcoming avoidanceCognitive 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. |
| Control | No intervention | –This is a no intervention control arm |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Participants are aged 14-16 years of age
- In the upper 66th percentile of test anxiety scores
Key exclusion criteria (2 listed)
- Participants are receiving other treatment for anxiety
- Participants have a diagnosis of clinical anxiety depression or Attention Deficit Hyperactivity Disorder
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 |
|---|---|---|
| Triggers for anxietyAlso: STEPSStudents learn about different triggers for anxiety, what the signs and indicators of anxiety are, and identify their own triggers for anxiety | Behavioural | Cognitive Behaviour Therapy, Cognitive Behaviour Therapy with 2 Booster Sessions |
| Identifying and challenging negative thoughtsAlso: STEPSStudents 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. | Behavioural | Cognitive Behaviour Therapy, Cognitive Behaviour Therapy with 2 Booster Sessions |
| RelaxationAlso: STEPSStudents are taught to relax through (1) breathing exercises, (2) progressive muscle relaxation, and (3) imagery. Student practice these techniques. | Behavioural | Cognitive Behaviour Therapy, Cognitive Behaviour Therapy with 2 Booster Sessions |
| Goal SettingAlso: STEPSStudents learn how to set goals, monitor goal progress, and check when goals have been achieved. Students then identify their own goals. | Behavioural | Cognitive Behaviour Therapy, Cognitive Behaviour Therapy with 2 Booster Sessions |
| Overcoming avoidanceAlso: STEPSStudents 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. | Behavioural | Cognitive Behaviour Therapy, Cognitive Behaviour Therapy with 2 Booster Sessions |
Primary outcome
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.
5 secondary outcomes
The Metacognition Questionnaire
Time frame: Change assessed over a 12 month period
Cognitive Emotion Regulation Questionnaire (short version)
Time frame: Change assessed over a 12 month period
Motivation and Engagement Scale (uncertain control subscale)
Time frame: Change assessed over a 12 month period
Revised Children's Anxiety and Depression Scale (panic, generalized anxiety, and social anxiety subscales)
Time frame: Change assessed over a 12 month period
School-related Wellbeing Scale
Time frame: Change assessed over a 12 month period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Individual participant dataSharing planned: Yes. 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
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Triggers for anxiety, Identifying and challenging negative thoughts and Relaxation in people with Anxiety, run by Liverpool John Moores University.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David W Putwain, PhD ((+44) 0151 231 5270 ext. 5270, d.w.putwain@ljmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test Anxiety Inventory (time frame: Change assessed over a 12 month period). 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 4 Sep 2020.