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AnxietyNCT02059226

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

A study testing cognitive behavioural therapy and Internet-based resource page in people with Anxiety, run by Mandi Newton at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Anxiety
What is being tested?
cognitive behavioural therapy and Internet-based resource page
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
3 sitesCanada
Study dates
Apr 2014to Nov 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • University of Alberta; Alberta Health Services

    Edmonton, Alberta, T6G 2B7

  • IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8

  • Children's Hospital of Eastern Ontario (CHEO)

    Ottawa, Ontario, K1H 8L1

Other trials in Canada

About this study

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.

Read more

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.
Conditions
Anxiety
Being tested
cognitive behavioural therapy, Internet-based resource page
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cognitive behavioural therapyBehavioural

    Internet-based CBT

  • Internet-based resource pageOther

    Static webpage

Study groups in NCT02059226
Study groupRoleWhat they receive
Internet-based CBTExperimentalInternet-based cognitive behavioural therapy
Receives: Behavioral: cognitive behavioural therapy
Internet-based resource pageActive comparatorStatic webpage
Receives: Other: Internet-based resource page

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in anxiety at 8 weeks

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

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

Secondary outcomes (7)

  1. Recruitment rate

    Measured: at 27 months

  2. Retention rate

    Measured: at 30 months

  3. Minimal Clinically Important Difference (MCID)

    We will ask youth allocated to the intervention arm about a MCID. The MCID represents the minimum change considered meaningful from the youth's perspective such that they consider treatment worth participating in. We will use the MCID to determine intervention effectiveness in a full-scale trial. To estimate the MCID, we will use youths' global ratings of change on a 10-point Likert scale (-5 to +5), a commonly used anchor.

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

  4. Intervention acceptability

    Satisfaction will be measured to infer intervention acceptability, which will be measured in youth allocated to the treatment arm. A 10-item instrument will measure engagement and sense of privacy, expectations and usefulness, communication, and technical (intervention) management. For 10 statements, a 4-point Likert response format ranging from strongly agree to strongly disagree will be used. Scores will range from 10 to 40 with scores ≥ 30 indicating higher acceptability.

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

  5. Co-intervention use

    We will ask youth whether they used other health care resources during the study (e.g., emergency department visit, other treatments, medication) and reasons for this use (e.g., unmet need, medication prescribed before the study).

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

  6. Resource use/costs

    The following will be reviewed: (i) software development and maintenance costs (for intervention maintenance and delivery), (ii) training and personnel costs for intervention, (iii) health care utilization data (e.g., self-reported visits to the emergency department, hospital admission), and (iv) other reported costs reported (i.e., time off from work/school).

    Measured: at 8 weeks

  7. Intervention adherence

    Intervention adherence will also be measured to infer intervention acceptability. Intervention adherence will be measured by documenting the number of modules and homework tasks completed. We will also record the number of tailored modules completed by each youth (treatment arm) and site visits (control arm). These data will be collected through the intervention's software system.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionOct 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02059226
Sponsor's protocol ID
Pro00036087
Other IDs
CIHR (MOP119531)
Status last verified
Apr 2017
First submitted
6 Feb 2014
Last updated
28 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32706720

  • 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.

    PubMed 26825111

Questions about this trial

What is this clinical trial studying?

A study testing cognitive behavioural therapy and Internet-based resource page in people with Anxiety, run by Mandi Newton at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in anxiety at 8 weeks (time frame: at 8 weeks (i.e., post-intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02059226, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.

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