AnxietyNCT05580081
Optimizing CBT Implementation Among Community Providers Through Internet-based Consultation and Networking (i-CAN)
A study testing i-CAN in people with Anxiety and CBT, run by University of Alabama, Tuscaloosa at 1 site in United States.
Trial summary
Although anxiety is one of the most common and debilitating mental health conditions affecting children and adolescents, the vast majority of sufferers do not receive effective treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- i-CAN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 1 Feb 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- provide direct mental healthcare to anxious youth
- practice in general community within state of Alabama
- agree to try i-CAN
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Youth Development and Intervention
Tuscaloosa, Alabama, 35487
About this study
Although anxiety is one of the most common and debilitating mental health conditions affecting children and adolescents, the vast majority of sufferers do not receive effective treatment. Cognitive-behavioral therapy (CBT) is an evidence-based, frontline treatment for pediatric anxiety, yet many community-based practitioners do not implement CBT with high fidelity, which can detrimentally affect its clinical impact. The goal of this study is to develop and test an online platform to support community providers' effective use of CBT for pediatric anxiety.
Read the detailed description
Stemming from implementation science and, specifically, the Theory of Planned Behavior, investigators are working alongside community stakeholders to develop a novel, online consultation platform. This platform, termed Internet-based Consultation or Networking (or i-CAN) will utilize a professional navigator (i.e., a provider with CBT expertise), online support and resources, and parallel peer consultation to create a user-friendly and supportive community for providers to get support as they implement CBT. Once finalized, the platform will be tested in the context of a preliminary randomized controlled trial (RCT) with approximately 100 mental healthcare providers who work with anxious children and adolescents. Providers who enroll will be randomly assigned to either the experimental condition (i-CAN) or the control condition (wait-list for i-CAN). The primary outcome of interest is change in intentions to use CBT.
- Being tested
- i-CAN
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-CANBehavioural
online support and consultation to providers
| Study group | Role | What they receive |
|---|---|---|
| i-CAN | Experimental | 18 weeks of access to the online consulting platform Receives: Behavioral: i-CAN |
| waitlist control | No intervention | No offered support or consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reasoned Action Questionnaire
Questionnaire that assesses instrumental beliefs, perceived norms, and self-efficacy (all related to use of cognitive-behavioral therapy). On the Reasoned Action Questionnaire, higher scores indicate greater intention to use the therapeutic approach. Scores can range from 14 to 90.
Measured: 18 weeks
Secondary outcomes (1)
Evidence-based practice attitude scale
Questionnaire that assesses views toward cognitive-behavioral therapy. Higher scores indicate more positive views. Scores can range from 0 to 60.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Apr 2023
- Primary completion1 Dec 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The RCT is a parallel group design, in which those in Control will be offered i-CAN after the 18 week waiting period.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan W White, PhD, Principal investigator, UA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580081
- Sponsor's protocol ID
- A22-0473
- Status last verified
- Apr 2025
- First submitted
- 11 Oct 2022
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared to NDA, and data requests can be issued directly to NDA.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing CBT Implementation Among Community Providers Through Internet-based Consultation and Networking (i-CAN)
- ClinicalTrials.gov ID
- NCT05580081
- Acronym / sponsor ID
- A22-0473
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although anxiety is one of the most common and debilitating mental health conditions affecting children and adolescents, the vast majority of sufferers do not receive effective treatment. Cognitive-behavioral therapy (CBT) is an evidence-based, frontline treatment for pediatric anxiety, yet many community-based practitioners do not implement CBT with high fidelity, which can detrimentally affect its clinical impact. The goal of this study is to develop and test an online platform to support community providers' effective use of CBT for pediatric anxiety.
Detailed description
Stemming from implementation science and, specifically, the Theory of Planned Behavior, investigators are working alongside community stakeholders to develop a novel, online consultation platform. This platform, termed Internet-based Consultation or Networking (or i-CAN) will utilize a professional navigator (i.e., a provider with CBT expertise), online support and resources, and parallel peer consultation to create a user-friendly and supportive community for providers to get support as they implement CBT. Once finalized, the platform will be tested in the context of a preliminary randomized controlled trial (RCT) with approximately 100 mental healthcare providers who work with anxious children and adolescents. Providers who enroll will be randomly assigned to either the experimental condition (i-CAN) or the control condition (wait-list for i-CAN). The primary outcome of interest is change in intentions to use CBT.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The RCT is a parallel group design, in which those in Control will be offered i-CAN after the 18 week waiting period.
| Arm | Type | Receives |
|---|---|---|
| i-CAN | Experimental | Behavioral: i-CAN18 weeks of access to the online consulting platform |
| waitlist control | No intervention | –No offered support or consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- provide direct mental healthcare to anxious youth
- practice in general community within state of Alabama
- agree to try i-CAN
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| i-CANonline support and consultation to providers | Behavioural | i-CAN |
Primary outcome
Reasoned Action Questionnaire
Time frame: 18 weeks
Questionnaire that assesses instrumental beliefs, perceived norms, and self-efficacy (all related to use of cognitive-behavioral therapy). On the Reasoned Action Questionnaire, higher scores indicate greater intention to use the therapeutic approach. Scores can range from 14 to 90.
1 secondary outcome
Evidence-based practice attitude scale
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No. Data will be shared to NDA, and data requests can be issued directly to NDA.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan W White, PhD principal investigator
UA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-CAN in people with Anxiety and CBT, run by University of Alabama, Tuscaloosa at 1 site in United States.
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 3 inclusion and 1 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 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Reasoned Action Questionnaire (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2025.