AnxietyNCT02970734
Evaluating an Internet-based Program for Anxious Adolescents
A study testing Breathe and Resource Webpage in people with Anxiety, run by University of Alberta at 1 site in Canada.
Trial summary
Anxiety is a common mental health problem for Canadian adolescents. Anxiety that is diagnosed as a disorder and serious enough to require treatment affects up to 10% of all adolescents by the age of 16. The median age of onset is 11 years, making these disorders some of the earliest to develop. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Breathe and Resource Webpage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 563 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2016to 22 Nov 2018
- 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Score of ≥25 on the Screen for Child Anxiety Related Disorders (SCARED)
- Ability to read and write English
- Regular access to a telephone and a computer system with high speed Internet service
- Ability to use the computer to interact with web material
Who cannot join
- Positive screen on the Ask Suicide-Screening Questionnaire (ASQ)
- Positive screen on the Schizophrenia Test and Early Psychosis Indicator (STEPI; modified version)
- Score of ≥3 on the Alcohol Use Disorders Identification Test Consumption subscale (AUDIT-C)
- Residence outside of Canada
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating an Internet-based Program for Anxious Adolescents: A Randomized Controlled Trial
Anxiety is a common mental health problem for Canadian adolescents. Anxiety that is diagnosed as a disorder and serious enough to require treatment affects up to 10% of all adolescents by the age of 16. The median age of onset is 11 years, making these disorders some of the earliest to develop. Anxiety disorders can have serious negative effects on a young person's personal relationships, school performance, and family life. These disorders may not be discovered by adolescents, parents and health care providers. Even if anxiety disorders are discovered, adolescents may not get the right therapy. Anxious adolescents can become sick if their anxiety is not treated properly. The investigators will carry out research to test Breathe, an Internet-based treatment for adolescents with anxiety problems. Adolescents can use this treatment from home via the computer. Breathe will include information materials and personalized homework assignments to help anxious adolescents learn ways to manage anxiety. More information can be found and www.TheBreatheStudy.com
Read the detailed description
This study is a randomized controlled trial (RCT) with two groups, an Internet-delivered cognitive behavioural therapy (CBT) experimental group (Breathe) and a resource webpage (control group; considered treatment as usual for youth waiting for services). The investigators will evaluate several methodological processes and outcomes through the following objectives:
- To determine the effectiveness of a self-guided Internet-based CBT program with limited telephone and email support in reducing anxiety symptoms among adolescents with mild-to-moderate anxiety as compared to a usual self-help intervention, a resource-based webpage.
- To explore mediators and moderators of the Internet-based CBT program.
- To determine the effectiveness of a self-guided Internet-based CBT program in improving quality of life as compared to a usual self-help intervention.
- To determine adherence to a self-guided Internet-based CBT program.
- To determine the cost-effectiveness of the Internet-based CBT program.
- Conditions
- Anxiety
- Being tested
- Breathe, Resource Webpage
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreatheBehavioural
Six web-based cognitive behavioural therapy sessions. Telephone and email support are also provided during the program.
Resource WebpageBehavioural
Static webpage listing anxiety resources.
| Study group | Role | What they receive |
|---|---|---|
| Breathe | Experimental | 6 sessions of Internet-based cognitive behavioural therapy (CBT) with limited telephone and e-mail support Receives: Behavioral: Breathe |
| Resource webpage | Active comparator | Webpage that provides general resources on anxiety Receives: Behavioral: Resource Webpage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adolescent anxiety using the total Multidimensional Anxiety Scale for Children (MASC 2) score
Measured: baseline to 6 weeks post-baseline (post-intervention)
Secondary outcomes (5)
Change in adolescent anxiety using the total MASC 2 score
Measured: 6 weeks post-baseline (post-intervention) to 18 weeks post-baseline (3-month follow-up)
Change in quality of life using the Youth Quality of Life Instrument - Short Form (YQOL-SF)
Measured: baseline to 6 weeks post-baseline (post-intervention), 6 weeks post-baseline (post-intervention) to 18 weeks post-baseline (3-month follow-up)
User experience
Developed by the investigators, this electronically administered, self-report instrument will assess participant satisfaction (e.g., ease of use, layout, convenience) perceived credibility and impact (e.g., helpfulness, knowledge gains, confidence in the program/website), and adherence and usage (e.g., barriers and facilitators to treatment) with an Internet-based program/webpage.
Measured: 6 weeks post-baseline (post-intervention)
Intervention adherence
Intervention adherence will be measured by documenting the number of sessions and homework tasks completed. The investigators will also record the number of tailored sessions completed by each participant (intervention condition) and site visits (control condition). These data will be collected through the intervention's software system.
Measured: 6 weeks post-baseline (post-intervention)
health care utilization
Developed by the investigators, this self-report instrument will assess whether participants have accessed health care resources (i.e., met with a psychologist/psychiatrist/family doctor/hospital etc.) and if so, how many times.
Measured: baseline, 18 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study start1 Dec 2016
- Primary completion30 Aug 2018
- Study completion22 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda Newton, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970734
- Sponsor's protocol ID
- Pro00066393
- Status last verified
- Sep 2018
- First submitted
- 16 Nov 2016
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
O'Connor KA, Bagnell A, Rosychuk RJ, Chen AA, Lingley-Pottie P, Radomski AD, Ohinmaa A, Joyce A, McGrath PJ, Newton AS. A randomized controlled trial evaluating the effect of an internet-based cognitive-behavioral program on anxiety symptoms in a community-based sample of adolescents. J Anxiety Disord. 2022 Dec;92:102637. doi: 10.1016/j.janxdis.2022.102637. Epub 2022 Sep 24.
PubMed 36179438Radomski AD, Bagnell A, Curtis S, Hartling L, Newton AS. Examining the Usage, User Experience, and Perceived Impact of an Internet-Based Cognitive Behavioral Therapy Program for Adolescents With Anxiety: Randomized Controlled Trial. JMIR Ment Health. 2020 Feb 7;7(2):e15795. doi: 10.2196/15795.
PubMed 32022692
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating an Internet-based Program for Anxious Adolescents: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02970734
- Acronym / sponsor ID
- Pro00066393
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 22 Nov 2018 (actual)
- First posted
- 22 Nov 2016 (estimated)
- 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.
Anxiety is a common mental health problem for Canadian adolescents. Anxiety that is diagnosed as a disorder and serious enough to require treatment affects up to 10% of all adolescents by the age of 16. The median age of onset is 11 years, making these disorders some of the earliest to develop. Anxiety disorders can have serious negative effects on a young person's personal relationships, school performance, and family life. These disorders may not be discovered by adolescents, parents and health care providers. Even if anxiety disorders are discovered, adolescents may not get the right therapy. Anxious adolescents can become sick if their anxiety is not treated properly. The investigators will carry out research to test Breathe, an Internet-based treatment for adolescents with anxiety problems. Adolescents can use this treatment from home via the computer. Breathe will include information materials and personalized homework assignments to help anxious adolescents learn ways to manage anxiety. More information can be found and www.TheBreatheStudy.com
Detailed description
This study is a randomized controlled trial (RCT) with two groups, an Internet-delivered cognitive behavioural therapy (CBT) experimental group (Breathe) and a resource webpage (control group; considered treatment as usual for youth waiting for services). The investigators will evaluate several methodological processes and outcomes through the following objectives:
- To determine the effectiveness of a self-guided Internet-based CBT program with limited telephone and email support in reducing anxiety symptoms among adolescents with mild-to-moderate anxiety as compared to a usual self-help intervention, a resource-based webpage.
- To explore mediators and moderators of the Internet-based CBT program.
- To determine the effectiveness of a self-guided Internet-based CBT program in improving quality of life as compared to a usual self-help intervention.
- To determine adherence to a self-guided Internet-based CBT program.
- To determine the cost-effectiveness of the Internet-based CBT program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathe | Experimental | Behavioral: Breathe6 sessions of Internet-based cognitive behavioural therapy (CBT) with limited telephone and e-mail support |
| Resource webpage | Active comparator | Behavioral: Resource WebpageWebpage that provides general resources on anxiety |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Score of ≥25 on the Screen for Child Anxiety Related Disorders (SCARED)
- Ability to read and write English
- Regular access to a telephone and a computer system with high speed Internet service
- Ability to use the computer to interact with web material
Key exclusion criteria (4 listed)
- Positive screen on the Ask Suicide-Screening Questionnaire (ASQ)
- Positive screen on the Schizophrenia Test and Early Psychosis Indicator (STEPI; modified version)
- Score of ≥3 on the Alcohol Use Disorders Identification Test Consumption subscale (AUDIT-C)
- Residence outside of Canada
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 |
|---|---|---|
| BreatheSix web-based cognitive behavioural therapy sessions. Telephone and email support are also provided during the program. | Behavioural | Breathe |
| Resource WebpageStatic webpage listing anxiety resources. | Behavioural | Resource webpage |
Primary outcome
Change in adolescent anxiety using the total Multidimensional Anxiety Scale for Children (MASC 2) score
Time frame: baseline to 6 weeks post-baseline (post-intervention)
5 secondary outcomes
Change in adolescent anxiety using the total MASC 2 score
Time frame: 6 weeks post-baseline (post-intervention) to 18 weeks post-baseline (3-month follow-up)
Change in quality of life using the Youth Quality of Life Instrument - Short Form (YQOL-SF)
Time frame: baseline to 6 weeks post-baseline (post-intervention), 6 weeks post-baseline (post-intervention) to 18 weeks post-baseline (3-month follow-up)
User experience
Time frame: 6 weeks post-baseline (post-intervention)
Intervention adherence
Time frame: 6 weeks post-baseline (post-intervention)
health care utilization
Time frame: baseline, 18 weeks post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Derived from this study: PubMed 36179438O'Connor KA, Bagnell A, Rosychuk RJ, Chen AA, Lingley-Pottie P, Radomski AD, Ohinmaa A, Joyce A, McGrath PJ, Newton AS. A randomized controlled trial evaluating the effect of an internet-based cognitive-behavioral program on anxiety symptoms in a community-based sample of adolescents. J Anxiety Disord. 2022 Dec;92:102637. doi: 10.1016/j.janxdis.2022.102637. Epub 2022 Sep 24.
- Derived from this study: PubMed 32022692Radomski AD, Bagnell A, Curtis S, Hartling L, Newton AS. Examining the Usage, User Experience, and Perceived Impact of an Internet-Based Cognitive Behavioral Therapy Program for Adolescents With Anxiety: Randomized Controlled Trial. JMIR Ment Health. 2020 Feb 7;7(2):e15795. doi: 10.2196/15795.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Recruiting
Internet-Based EMDR Flash Intervention for Test Anxiety in University Students
Test Anxiety
Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
Recruiting
High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Anxiety
Recurrent Pregnancy Loss(RPL), Anxiety
Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder: A Randomized Controlled Trial
Obsessive - Compulsive Disorder, Family Accommodation
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.
Amanda Newton principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathe and Resource Webpage in people with Anxiety, run by University of Alberta at 1 site in Canada.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in adolescent anxiety using the total Multidimensional Anxiety Scale for Children (MASC 2) score (time frame: baseline to 6 weeks post-baseline (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02970734, which also lists 2 linked publications.
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 2 May 2019.