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

NCT02059226 | Completed

• 2 other identifiers: Pro00036087CIHR (MOP119531)
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• Change from baseline in anxiety at 8 weeks

  Anxiety will be measured using the Multidimensional Anxiety Scale for Children (MASC2)

  at 8 weeks (i.e., post-intervention)

Secondary Outcomes (7)

• Recruitment rate

  at 27 months

• Retention rate

  at 30 months

• Minimal Clinically Important Difference (MCID)

  at 8 weeks (i.e., post-intervention)

• Intervention acceptability

  at 8 weeks (i.e., post-intervention)

• Co-intervention use

  at 8 weeks (i.e., post-intervention)

Study Arms (2)

Internet-based CBT

EXPERIMENTAL

Internet-based cognitive behavioural therapy

Behavioral: cognitive behavioural therapy

Internet-based resource page

ACTIVE COMPARATOR

Static webpage

Other: Internet-based resource page

Interventions

cognitive behavioural therapy BEHAVIORAL

Internet-based CBT

Internet-based CBT

Internet-based resource page OTHER

Static webpage

Internet-based resource page

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mandi Newton: lead
• IWK Health Centre: collaborator

Study Sites (3)

University of Alberta; Alberta Health Services

Edmonton, Alberta, T6G 2B7, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Children's Hospital of Eastern Ontario (CHEO)

Ottawa, Ontario, K1H 8L1, Canada

Location

Related Publications (2)

• O'Connor K, Bagnell A, McGrath P, Wozney L, Radomski A, Rosychuk RJ, Curtis S, Jabbour M, Fitzpatrick E, Johnson DW, Ohinmaa A, Joyce A, Newton A. An Internet-Based Cognitive Behavioral Program for Adolescents With Anxiety: Pilot Randomized Controlled Trial. JMIR Ment Health. 2020 Jul 24;7(7):e13356. doi: 10.2196/13356.

  PMID: 32706720 DERIVED

• Newton AS, Wozney L, Bagnell A, Fitzpatrick E, Curtis S, Jabbour M, Johnson D, Rosychuk RJ, Young M, Ohinmaa A, Joyce A, McGrath P. Increasing Access to Mental Health Care With Breathe, an Internet-Based Program for Anxious Adolescents: Study Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2016 Jan 29;5(1):e18. doi: 10.2196/resprot.4428.

  PMID: 26825111 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Amanda Newton

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 11, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 28, 2017

Record last verified: 2017-04

Locations

CA (3)