Trial Outcomes & Findings for Youth Mayo Clinic Anxiety Coach Pilot Study (NCT NCT02205177)
NCT ID: NCT02205177
Last Updated: 2019-08-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Within 5 working days of Treatment Completion
Results posted on
2019-08-05
Participant Flow
Participant milestones
| Measure |
Face-to-Face w/ Anxiety Coach (FTF-AC)
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, \& review progress in-session via the web-based portal.
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 \& patient adherence to evidence-based treatment. The design of Anxiety Coach is based on evidence \& theory suggesting that information and communication technologies (ICTs) are well-suited for encouraging
|
Minimal Contact w/ Anxiety Coach (MC-AC)
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 \& up to 12 weeks of intervention. Therapists will be allowed 2 additional face-to-face sessions if necessary and still remain in protocol.
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 communicatio
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|---|---|---|
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Overall Study
STARTED
|
8
|
2
|
|
Overall Study
COMPLETED
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Youth Mayo Clinic Anxiety Coach Pilot Study
Baseline characteristics by cohort
| Measure |
Face-to-Face w/ Anxiety Coach (FTF-AC)
n=8 Participants
Therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using Anxiety Coach. The sessions occur weekly \& within the office. Therapists will use Anxiety Coach at each session, encouraging patients to use the application to complete homework, \& review progress in-session via the web-based portal.
Mayo Clinic Anxiety Coach, a smartphone application based on cognitive-behavioral treatment for anxiety disorders can be used as a stand-alone treatment using minimal provider contact \& an augmentation of face-to-face treatment that increases clinician fidelity \& patient adherence to evidence-based treatment. Anxiety Coach's design is based on evidence \& theory suggesting that information \& communication technologies (ICTs) are well-suited for encouraging behavior change through scheduled reminders to engage in therapeutic exercises; point of performance support; individually tailored information; real-time symptom assessment \& readily accessible asynchronous communication.
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Minimal Contact w/ Anxiety Coach (MC-AC)
n=2 Participants
Therapist's will meet with the patient \& parent for an initial 50-minute, face-to-face session to give a tutorial on using Anxiety Coach. The therapist will review the patient's progress via the web-based portal \& communicate with patients electronically weekly for a total of 6 to 12 weeks of intervention.
Mayo Clinic Anxiety Coach, a smartphone application based on cognitive-behavioral treatment for anxiety disorders can be used as a stand-alone treatment using minimal provider contact \& an augmentation of face-to-face treatment that increases clinician fidelity \& patient adherence to evidence-based treatment. Anxiety Coach's design is based on evidence \& theory suggesting that information \& communication technologies (ICTs) are well-suited for encouraging behavior change through scheduled reminders to engage in therapeutic exercises; point of performance support; individually tailored information; real-time symptom assessment \& readily accessible asynchronous communication.
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Total
n=10 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 5 working days of Treatment CompletionThe 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.
Outcome measures
| Measure |
Face-to-Face w/ Anxiety Coach (FTF-AC)
n=8 Participants
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.
|
Minimal Contact w/ Anxiety Coach (MC-AC)
n=2 Participants
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.
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|---|---|---|
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Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) at Treatment Completion
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11 score on a scale
Standard Deviation 3.1
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-1 score on a scale
Standard Deviation .7
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SECONDARY outcome
Timeframe: Within 5 working days of Treatment CompletionPopulation: No families from minimal contact responded to interview request. three of the families from the Face to Face condition did not respond to invitation to interview.
The number of patients that completed the summary of the qualitative interview will be used to enhance Anxiety Coach
Outcome measures
| Measure |
Face-to-Face w/ Anxiety Coach (FTF-AC)
n=5 Participants
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.
|
Minimal Contact w/ Anxiety Coach (MC-AC)
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.
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|---|---|---|
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Number of Participants Who Completed the Subject Safety and Treatment Adherence Interview
|
5 Participants
|
0 Participants
|
Adverse Events
Face-to-Face w/ Anxiety Coach (FTF-AC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Minimal Contact w/ Anxiety Coach (MC-AC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place