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Completed

NCT Number: NCT02970734

Evaluating an Internet-based Program for Anxious Adolescents

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

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Breathe Team

Edmonton, Alberta, T5N 3G8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breathe

Behavioral

Six web-based cognitive behavioural therapy sessions. Telephone and email support are also provided during the program.

Resource Webpage

Behavioral

Static webpage listing anxiety resources.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. User experience

    Time frame: 6 weeks post-baseline (post-intervention)

    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.

  4. Intervention adherence

    Time frame: 6 weeks post-baseline (post-intervention)

    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.

  5. health care utilization

    Time frame: baseline, 18 weeks post-baseline

    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.

Other outcomes

  1. Recruitment rate

    Time frame: Through study conduct, an average of 1 year.

  2. Retention rate

    Time frame: Through study conduct, an average of 1 year.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 22, 2016
Registry last updated
May 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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