Evaluating an Internet-based Program for Anxious Adolescents

NCT02970734 | Completed

• 1 other identifier: Pro00066393
• Study Type: interventional
• Target: 563
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in adolescent anxiety using the total Multidimensional Anxiety Scale for Children (MASC 2) score

  baseline to 6 weeks post-baseline (post-intervention)

Secondary Outcomes (5)

• 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

  6 weeks post-baseline (post-intervention)

• Intervention adherence

  6 weeks post-baseline (post-intervention)

• health care utilization

  baseline, 18 weeks post-baseline

Other Outcomes (2)

• Recruitment rate

  Through study conduct, an average of 1 year.

• Retention rate

  Through study conduct, an average of 1 year.

Study Arms (2)

Breathe

EXPERIMENTAL

6 sessions of Internet-based cognitive behavioural therapy (CBT) with limited telephone and e-mail support

Behavioral: Breathe

Resource webpage

ACTIVE COMPARATOR

Webpage that provides general resources on anxiety

Behavioral: Resource Webpage

Interventions

Breathe BEHAVIORAL

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

Breathe

Resource Webpage BEHAVIORAL

Static webpage listing anxiety resources.

Resource webpage

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

The Breathe Team

Edmonton, Alberta, T5N 3G8, Canada

Location

Related Publications (2)

• 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.

  PMID: 36179438 DERIVED

• 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.

  PMID: 32022692 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Officials

• Amanda Newton

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 22, 2016
• Study Start: December 1, 2016
• Primary Completion: August 30, 2018
• Study Completion: November 22, 2018
• Last Updated: May 2, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)