Back to resultsYouth Mayo Clinic Anxiety Coach Pilot Study
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mayo Clinic Anxiety Coach
Sponsored by
About this trial
This is an interventional other trial for Anxiety focused on measuring Anxiety, Social Anxiety, Social Phobia, Separation Anxiety, Generalized Anxiety, GAD, Phobia, Panic, Agoraphobia, Obsessive Compulsive Disorder, OCD, Child, Adolescent, Smartphone, Teen, Youth
Eligibility Criteria
Inclusion Criteria:
- Age 7 to 17
Primary diagnosis of:
- social phobia,
- separation anxiety disorder,
- panic disorder with and without agoraphobia,
- specific phobia, or
- 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
Exclusion Criteria:
History of and/or current diagnosis of:
- psychosis,
- autism,
- bipolar disorder,
- mental retardation,
- oppositional defiant disorder,
- 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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Face-to-Face w/ Anxiety Coach (FTF-AC)
Minimal Contact w/ Anxiety Coach (MC-AC)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02205177
First Posted
July 29, 2014
Last Updated
August 1, 2019
Sponsor
Stephen Whiteside
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT02205177
Brief Title
Youth Mayo Clinic Anxiety Coach Pilot Study
Official Title
Expanding Access to Therapy for Childhood Anxiety Disorders Via Smart Phones - PILOT
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 15, 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stephen Whiteside
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Anxiety, Social Anxiety, Social Phobia, Separation Anxiety, Generalized Anxiety, GAD, Phobia, Panic, Agoraphobia, Obsessive Compulsive Disorder, OCD, Child, Adolescent, Smartphone, Teen, Youth
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Face-to-Face w/ Anxiety Coach (FTF-AC)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Minimal Contact w/ Anxiety Coach (MC-AC)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Mayo Clinic Anxiety Coach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) at Treatment Completion
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants Who Completed the Subject Safety and Treatment Adherence Interview
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 7 to 17
Primary diagnosis of:
social phobia,
separation anxiety disorder,
panic disorder with and without agoraphobia,
specific phobia, or
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
Exclusion Criteria:
History of and/or current diagnosis of:
psychosis,
autism,
bipolar disorder,
mental retardation,
oppositional defiant disorder,
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Whiteside, PhD, LP
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Youth Mayo Clinic Anxiety Coach Pilot Study
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