An interventional study of Mayo Clinic Anxiety Coach in Anxiety, sponsored by Stephen Whiteside. Completed at 1 site in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-08-05.
Sponsored by Stephen Whiteside · Not applicable, Interventional, and Other
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.
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.
5,065 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's enrollment of 10 is below the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Stephen Whiteside is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Primary diagnosis of:
Exclusion Criteria:
History of and/or current diagnosis of:
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.
Device: Mayo Clinic Anxiety Coach
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.
Device: Mayo Clinic Anxiety Coach
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.
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.
Time frame: Within 5 working days of Treatment Completion
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
Time frame: Within 5 working days of Treatment Completion
| Milestone | Face-to-Face w/ Anxiety Coach (FTF-AC) | Minimal Contact w/ Anxiety Coach (MC-AC) |
|---|---|---|
| Started | 8 | 2 |
| Completed | 6 | 2 |
| Not completed | 2 | 0 |
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.
| score on a scale | Face-to-Face w/ Anxiety Coach (FTF-AC) | Minimal Contact w/ Anxiety Coach (MC-AC) |
|---|---|---|
| Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) at Treatment Completion | 11 ± 3.1 | -1 ± .7 |
The number of patients that completed the summary of the qualitative interview will be used to enhance Anxiety Coach
| Participants | Face-to-Face w/ Anxiety Coach (FTF-AC) | Minimal Contact w/ Anxiety Coach (MC-AC) |
|---|---|---|
| Number of Participants Who Completed the Subject Safety and Treatment Adherence Interview | 5 | 0 |
Collected over 11 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Face-to-Face w/ Anxiety Coach (FTF-AC) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Minimal Contact w/ Anxiety Coach (MC-AC) | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Face-to-Face w/ Anxiety Coach (FTF-AC) | Minimal Contact w/ Anxiety Coach (MC-AC) | Total |
|---|---|---|---|
| <=18 years | 8 | 2 | 10 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Face-to-Face w/ Anxiety Coach (FTF-AC) | Minimal Contact w/ Anxiety Coach (MC-AC) | Total |
|---|---|---|---|
| Female | 5 | 2 | 7 |
| Male | 3 | 0 | 3 |
| Race (NIH/OMB)(Participants) | Face-to-Face w/ Anxiety Coach (FTF-AC) | Minimal Contact w/ Anxiety Coach (MC-AC) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 8 | 2 | 10 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Jan 2016 to primary completion in Mar 2017, 14 months.
Results were first posted in Aug 2019, 2 years 5 months after primary completion.
Of 2,720 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 14 months is close to that.
Counting every sponsor, half of 2,789 studies reached it within 12 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Stephen Whiteside