Evaluating an Internet-based Program for Anxious Adolescents

Anxiety Clinical Trial

Official title:

Evaluating an Internet-based Program for Anxious Adolescents: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970734
• Other study ID #: Pro00066393
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: November 22, 2018

Study information

• Verified date: September 2018
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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:

1. 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.

2. To explore mediators and moderators of the Internet-based CBT program.

3. 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.

4. To determine adherence to a self-guided Internet-based CBT program.

5. To determine the cost-effectiveness of the Internet-based CBT program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 563
• Est. completion date: November 22, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anxiety

Intervention

Behavioral:
• Breathe
Six web-based cognitive behavioural therapy sessions. Telephone and email support are also provided during the program.
• Resource Webpage
Static webpage listing anxiety resources.

Locations

Country	Name	City	State
Canada	The Breathe Team	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recruitment rate		Through study conduct, an average of 1 year.
Other	Retention rate		Through study conduct, an average of 1 year.
Primary	Change in adolescent anxiety using the total Multidimensional Anxiety Scale for Children (MASC 2) score		baseline to 6 weeks post-baseline (post-intervention)
Secondary	Change in adolescent anxiety using the total MASC 2 score		6 weeks post-baseline (post-intervention) to 18 weeks post-baseline (3-month follow-up)
Secondary	Change in quality of life using the Youth Quality of Life Instrument - Short Form (YQOL-SF)		baseline to 6 weeks post-baseline (post-intervention), 6 weeks post-baseline (post-intervention) to 18 weeks post-baseline (3-month follow-up)
Secondary	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.	6 weeks post-baseline (post-intervention)
Secondary	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.	6 weeks post-baseline (post-intervention)
Secondary	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.	baseline, 18 weeks post-baseline