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Youth Mayo Clinic Anxiety Coach Randomized Controlled Trial

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mayo Clinic Anxiety Coach
Treatment as Usual
Sponsored by
Stephen Whiteside
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment 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

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 7 to 17

  2. Primary diagnosis of:

    1. social phobia,
    2. separation anxiety disorder,
    3. panic disorder with and without agoraphobia,
    4. specific phobia, or
    5. obsessive compulsive disorder
  3. A parent or other primary care giver available to participate with the child in all assessment and treatment activities
  4. Estimated average intelligence
  5. English speaking

Exclusion Criteria:

  1. History of and/or current diagnosis of:

    1. psychosis,
    2. autism,
    3. bipolar disorder,
    4. mental retardation,
    5. oppositional defiant disorder,
    6. PTSD,
    7. selective mutism, or
    8. major depressive disorder
  2. Current suicidality or recent suicidal behavior
  3. Parent to be involved in study who is unable to adequately participate due to intellectual or psychiatric difficulties
  4. 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)

Treatment as Usual (TAU)

Arm Description

In this condition therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using Mayo Clinic 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 the TAU condition therapists provide treatment consistent with their orientation and clinical judgment. Previous research suggests that TAU will include supportive therapy, relaxation, and cognitive restructuring. The format of treatment will be 6 to 12, 50-minute, face-to-face therapy sessions in the therapist's office, with flexibility to leave the office (e.g., for exposure). Therapists can communicate with patients between sessions (e.g., phone calls), as long as this medium is not the primary mode of treatment.

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.

Secondary Outcome Measures

Full Information

First Posted
July 29, 2014
Last Updated
March 24, 2021
Sponsor
Stephen Whiteside
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02205203
Brief Title
Youth Mayo Clinic Anxiety Coach Randomized Controlled Trial
Official Title
Expanding Access to Therapy for Childhood Anxiety Disorders Via Smart Phones - RCT
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
March 1, 2021 (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

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
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
60 therapists in underserved areas will treat children with anxiety disorders in one of three conditions (treatment as usual, Anxiety Coach with face-to-face therapy, or Anxiety Coach with minimal direct contact) to determine the feasibility of using of Anxiety Coach to increase the frequency of exposure and improve outcomes with varying degrees of face-to-face contact (N = 60 patients).

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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
145 (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 Mayo Clinic 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
Treatment as Usual (TAU)
Arm Type
Experimental
Arm Description
In the TAU condition therapists provide treatment consistent with their orientation and clinical judgment. Previous research suggests that TAU will include supportive therapy, relaxation, and cognitive restructuring. The format of treatment will be 6 to 12, 50-minute, face-to-face therapy sessions in the therapist's office, with flexibility to leave the office (e.g., for exposure). Therapists can communicate with patients between sessions (e.g., phone calls), as long as this medium is not the primary mode of treatment.
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.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
In the TAU condition therapists provide treatment consistent with their orientation and clinical judgment. Previous research suggests that TAU will include supportive therapy, relaxation, and cognitive restructuring. The format of treatment will be 6 to 12, 50-minute, face-to-face therapy sessions in the therapist's office, with flexibility to leave the office (e.g., for exposure).
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.
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, Ph.D., L.P.
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
Links:
URL
http://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Youth Mayo Clinic Anxiety Coach Randomized Controlled Trial

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