Evaluating an Internet-based Program for Anxious Adolescents

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

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: Breathe; Behavioral: Resource Webpage

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:

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.

• Study Type: Interventional
• Enrollment (Actual): 563
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5N 3G8
      • The Breathe Team

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Breathe; 6 sessions of Internet-based cognitive behavioural therapy (CBT) with limited telephone and e-mail support	Behavioral: Breathe; Six web-based cognitive behavioural therapy sessions. Telephone and email support are also provided during the program.
ACTIVE_COMPARATOR: Resource webpage; Webpage that provides general resources on anxiety	Behavioral: Resource Webpage; Static webpage listing anxiety resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in adolescent anxiety using the total Multidimensional Anxiety Scale for Children (MASC 2) score	baseline to 6 weeks post-baseline (post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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

Other Outcome Measures

Outcome Measure	Time Frame
Recruitment rate	Through study conduct, an average of 1 year.
Retention rate	Through study conduct, an average of 1 year.

Collaborators and Investigators

• Sponsor: University of Alberta

Publications and helpful links

General Publications

• Radomski 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ACTUAL): August 30, 2018
• Study Completion (ACTUAL): November 22, 2018

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: November 17, 2016
• First Posted (ESTIMATE): November 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2019
• Last Update Submitted That Met QC Criteria: April 30, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Pro00066393

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO