Evaluating an Internet-based Program for Anxious Youth: a Pilot RCT

Mandi Newton

Status: Completed

Conditions: Anxiety

Treatments: Behavioral: cognitive behavioural therapy; Other: Internet-based resource page

Study type: Interventional

Funder types: Other

Identifiers

NCT02059226

Pro00036087

CIHR (MOP119531) (Other Grant/Funding Number)

Details and patient eligibility

About

Anxiety is a common mental health problem for Canadian youth. Anxiety that is diagnosed as a disorder and serious enough to require treatment affects up to 10% of all youth by the age of 16. 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 youth, parents and health care providers. Even if anxiety disorders are discovered, youth may not get the right therapy. Anxious youth can become sick if their anxiety is not treated properly.

The investigative team will carry out research to test Breathe, their new Internet-based treatment for youth with anxiety problems. Youth can use this treatment at home. Breathe includes information materials and personalized homework assignments to help anxious youth learn ways to manage anxiety.

This study is a pilot 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 evaluate the change in youths' anxiety (primary outcome) from pre- to post- intervention.
2. To estimate recruitment and retention rates for a full-scale RCT.
3. To estimate a sample size for a full-scale RCT.
4. To define the minimal clinically important difference (MCID) for the primary outcome measure.
5. To measure intervention acceptability.
6. To determine the use of co-interventions during the trial.
7. To conduct a preliminary economic analysis.

Enrollment: 94 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• DSM-IV social anxiety, generalized anxiety, anxiety not otherwise specified, or adjustment disorder as the primary clinical problem
• ability to read and write English
• regular access to a telephone and a computer system with high speed Internet service
• ability to use a computer to interact with web material
• youth aged 13-14 must have a consenting parent

Exclusion criteria

• youth with an anxiety problem that is not included above
• youth who receive cognitive behavioural therapy
• youth who cannot provide consent

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Internet-based CBT

Experimental group

Description:

Internet-based cognitive behavioural therapy

Treatment:

Behavioral: cognitive behavioural therapy

Internet-based resource page

Active Comparator group

Description:

Static webpage

Treatment:

Other: Internet-based resource page