Youth Mayo Clinic Anxiety Coach Pilot Study

NCT ID: NCT02205177

Last Updated: 2019-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-15
• Study Completion Date: 2017-03-31

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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, and review progress in-session via the web-based portal.

Group Type: ACTIVE_COMPARATOR

Mayo Clinic Anxiety Coach

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Mayo Clinic Anxiety Coach

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Stephen Whiteside

OTHER

Sponsor Role: lead

Responsible Party

Stephen Whiteside

Associate Professor of Psychology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stephen Whiteside, PhD, LP

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R34MH100468

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-000288 - PILOT

Identifier Type: -

Identifier Source: org_study_id