AnxietyNCT02205177
Youth Mayo Clinic Anxiety Coach Pilot Study
A study testing Mayo Clinic Anxiety Coach in people with Anxiety, run by Stephen Whiteside at 1 site in United States.
Trial summary
This research study aims to test the feasibility and effectiveness of using the Mayo Clinic Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of anxiety disorders in youth, particularly those youth who may have limited access to mental health treatment in the traditional clinical… Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Mayo Clinic Anxiety Coach
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 7 to 17
- Primary diagnosis of:
- social phobia,
- separation anxiety disorder,
- panic disorder with and without agoraphobia,
- specific phobia, or
Show all 10Show fewer
- obsessive compulsive disorder
- A parent or other primary care giver available to participate with the child in all assessment and treatment activities
- Estimated average intelligence
- English speaking
Who cannot join
- History of and/or current diagnosis of:
- psychosis,
- autism,
- bipolar disorder,
- mental retardation,
- oppositional defiant disorder,
Show all 12Show fewer
- PTSD,
- selective mutism, or
- major depressive disorder
- Current suicidality or recent suicidal behavior
- Parent to be involved in study who is unable to adequately participate due to intellectual or psychiatric difficulties
- Starting or changing the dosage of a psychiatric medication in the last two months
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Expanding Access to Therapy for Childhood Anxiety Disorders Via Smart Phones - PILOT
This research study aims to test the feasibility and effectiveness of using the Mayo Clinic Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of anxiety disorders in youth, particularly those youth who may have limited access to mental health treatment in the traditional clinical setting.
Read the detailed description
This research study aims to test the feasibility and effectiveness of using the Mayo Clinic Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of anxiety disorders in youth, particularly those youth who may have limited access to mental health treatment in the traditional clinical setting. Therapist will provide CBT to patients with infrequent face-to-face contact and then will examine the acceptability, ease of use and need for contact.
- Conditions
- Anxiety
- Being tested
- Mayo Clinic Anxiety Coach
- Keywords
- Anxiety, Social Anxiety, Social Phobia, Separation Anxiety, Generalized Anxiety, GAD, Phobia, Panic, Agoraphobia, Obsessive Compulsive Disorder, OCD, Child, Adolescent, Smartphone, Teen, Youth
- Medical subject headings
- Anxiety Disorders, Phobia, Social, Anxiety, Separation, Generalized Anxiety Disorder, Phobic Disorders, Agoraphobia, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mayo Clinic Anxiety CoachDevice
Mayo Clinic Anxiety Coach is a smartphone application based on cognitive-behavioral treatment for anxiety disorders (i.e., exposure-based therapy) that can be used as 1) a stand-alone treatment requiring minimal provider contact, and 2) an augmentation of face-to-face treatment that increases clinician fidelity and patient adherence to evidence-based treatment. The design of Anxiety Coach is based on evidence and theory suggesting that information and communication technologies (ICTs) are well-suited for encouraging behavior change through 1) scheduled reminders to engage in therapeutic exercises, 2) point of performance support, 3) individually tailored information, 4) real-time symptom assessment, and 5) readily accessible asynchronous communication.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-Face w/ Anxiety Coach (FTF-AC) | Active comparator | In this condition therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using Anxiety Coach. The sessions are expected to initially occur weekly and be within the office although the therapist can leave the office to conduct exposure. The therapist is expected to utilize Anxiety Coach within the session, encourage the patient to use the application to complete homework, and review progress in-session via the web-based portal. Receives: Device: Mayo Clinic Anxiety Coach |
| Minimal Contact w/ Anxiety Coach (MC-AC) | Experimental | In this condition the therapist will meet with the patient and primary care giver for an initial 50-minute, face-to-face session to provide a tutorial on the use of Anxiety Coach. The therapist is expected to review the patient's progress via the web-based portal and communicate with the patient electronically at least once per week for a total of at least 6 and up to 12 weeks of intervention. Therapists will be allowed 2 additional face-to-face sessions if necessary and still remain in protocol. Receives: Device: Mayo Clinic Anxiety Coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) at Treatment Completion
The Pediatric Anxiety Rating Scale (PARS) is an interview-based tool used to assess for the presence and severity of anxiety symptoms in children and adolescents utilizing parental and youth input to guide clinician ratings. The PARS has 5 questions. Four of those questions has a scale ranging from none (1) to extreme (5). The other question has a rating of 1-5. The total score ranges from 0 - 25, with 25 being the worst.
Measured: Within 5 working days of Treatment Completion
Secondary outcomes (1)
Number of Participants Who Completed the Subject Safety and Treatment Adherence Interview
The number of patients that completed the summary of the qualitative interview will be used to enhance Anxiety Coach
Measured: Within 5 working days of Treatment Completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study start15 Jan 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephen Whiteside
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Stephen Whiteside, Mayo Clinic
- Investigators
- Stephen Whiteside, PhD, LP, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205177
- Sponsor's protocol ID
- 13-000288 - PILOT
- Other IDs
- R34MH100468
- Status last verified
- Aug 2019
- First submitted
- 29 Jul 2014
- Last updated
- 5 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Access to Therapy for Childhood Anxiety Disorders Via Smart Phones - PILOT
- ClinicalTrials.gov ID
- NCT02205177
- Acronym / sponsor ID
- 13-000288 - PILOT
- Conditions
- Anxiety
- Keywords
- Anxiety, Social Anxiety, Social Phobia, Separation Anxiety, Generalized Anxiety, GAD, Phobia, Panic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Stephen WhitesideUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 31 Jul 2014 (estimated)
- Results
- Posted 5 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study aims to test the feasibility and effectiveness of using the Mayo Clinic Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of anxiety disorders in youth, particularly those youth who may have limited access to mental health treatment in the traditional clinical setting.
Detailed description
This research study aims to test the feasibility and effectiveness of using the Mayo Clinic Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of anxiety disorders in youth, particularly those youth who may have limited access to mental health treatment in the traditional clinical setting. Therapist will provide CBT to patients with infrequent face-to-face contact and then will examine the acceptability, ease of use and need for contact.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face-to-Face w/ Anxiety Coach (FTF-AC) | Active comparator | Device: Mayo Clinic Anxiety CoachIn this condition therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using Anxiety Coach. The sessions are expected to initially occur weekly and be within the office although the therapist can leave the office to conduct exposure. The therapist is expected to utilize Anxiety Coach within the session, encourage the patient to use the application to complete homework, and review progress in-session via the web-based portal. |
| Minimal Contact w/ Anxiety Coach (MC-AC) | Experimental | Device: Mayo Clinic Anxiety CoachIn this condition the therapist will meet with the patient and primary care giver for an initial 50-minute, face-to-face session to provide a tutorial on the use of Anxiety Coach. The therapist is expected to review the patient's progress via the web-based portal and communicate with the patient electronically at least once per week for a total of at least 6 and up to 12 weeks of intervention. Therapists will be allowed 2 additional face-to-face sessions if necessary and still remain in protocol. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Age 7 to 17
- Primary diagnosis of:
- A parent or other primary care giver available to participate with the child in all assessment and treatment activities
- Estimated average intelligence
- English speaking
Key exclusion criteria (12 listed)
- History of and/or current diagnosis of:
- Current suicidality or recent suicidal behavior
- Parent to be involved in study who is unable to adequately participate due to intellectual or psychiatric difficulties
- Starting or changing the dosage of a psychiatric medication in the last two months
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 |
|---|---|---|
| Mayo Clinic Anxiety CoachMayo Clinic Anxiety Coach is a smartphone application based on cognitive-behavioral treatment for anxiety disorders (i.e., exposure-based therapy) that can be used as 1) a stand-alone treatment requiring minimal provider contact, and 2) an augmentation of face-to-face treatment that increases clinician fidelity and patient adherence to evidence-based treatment. The design of Anxiety Coach is based on evidence and theory suggesting that information and communication technologies (ICTs) are well-suited for encouraging behavior change through 1) scheduled reminders to engage in therapeutic exercises, 2) point of performance support, 3) individually tailored information, 4) real-time symptom assessment, and 5) readily accessible asynchronous communication. | Device | Face-to-Face w/ Anxiety Coach (FTF-AC), Minimal Contact w/ Anxiety Coach (MC-AC) |
Primary outcome
Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) at Treatment Completion
Time frame: Within 5 working days of Treatment Completion
The Pediatric Anxiety Rating Scale (PARS) is an interview-based tool used to assess for the presence and severity of anxiety symptoms in children and adolescents utilizing parental and youth input to guide clinician ratings. The PARS has 5 questions. Four of those questions has a scale ranging from none (1) to extreme (5). The other question has a rating of 1-5. The total score ranges from 0 - 25, with 25 being the worst.
1 secondary outcome
Number of Participants Who Completed the Subject Safety and Treatment Adherence Interview
Time frame: Within 5 working days of Treatment Completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Stephen Whiteside, PhD, LP principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mayo Clinic Anxiety Coach in people with Anxiety, run by Stephen Whiteside 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 10 inclusion and 12 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 5 Aug 2019. 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?
Yes. Results are posted in the registry (first posted 5 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) at Treatment Completion (time frame: Within 5 working days of Treatment Completion). 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 5 Aug 2019.