Evaluating an Internet-based Program for Anxious Youth: a... | NCT02059226

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

NCT02059226

Sponsor

Mandi Newton

Status

Completed

Last Update Posted

Apr 28, 2017Actual

Enrollment

94Actual

Phase

Not Applicable

Conditions

Anxiety

Interventions

cognitive behavioural therapy
Internet-based resource page

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CIHR (MOP119531)	Other Grant/Funding Number	Canadian Institutes of Health Research

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Oct 2016Actual

Completion Date

Nov 2016Actual

First Submitted Date

Feb 6, 2014

First Submission Date that Met QC Criteria

Feb 7, 2014

First Posted Date

Feb 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2017

Last Update Posted Date

Apr 28, 2017Actual

Name	Class
IWK Health Centre	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

94Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
cognitive behavioural therapy	Behavioral	Internet-based CBT	Internet-based CBT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Recruitment rate		at 27 months
Retention rate		at 30 months
Minimal Clinically Important Difference (MCID)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amanda Newton	University of Alberta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alberta; Alberta Health Services		Edmonton	Alberta	T6G 2B7	Canada
IWK Health Centre

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32706720	Derived	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.
26825111

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities