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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH100468 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mayo Clinic Anxiety Coach | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 5 working days of Treatment Completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 5 working days of Treatment Completion |
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Inclusion Criteria:
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
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Whiteside, PhD, LP | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Face-to-Face w/ Anxiety Coach (FTF-AC) | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Within 5 working days of Treatment Completion |
|
11 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Face-to-Face w/ Anxiety Coach (FTF-AC) | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen P Whiteside, PhD, LP | Mayo Clinic | 507-284-2933 | Whiteside.Stephen@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 1, 2019 | Jul 31, 2019 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2019 | Jul 31, 2019 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000072861 | Phobia, Social |
| D001010 | Anxiety, Separation |
| D000098647 | Generalized Anxiety Disorder |
| D010698 | Phobic Disorders |
| D000379 | Agoraphobia |
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D065886 | Neurodevelopmental Disorders |
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|
| BG001 | Minimal Contact w/ Anxiety Coach (MC-AC) | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | 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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| Secondary | 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 | 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. | Posted | Count of Participants | Participants | Within 5 working days of Treatment Completion |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Minimal Contact w/ Anxiety Coach (MC-AC) | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
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