Youth Mayo Clinic Anxiety Coach Pilot Study

Anxiety Clinical Trial

Official title:

Expanding Access to Therapy for Childhood Anxiety Disorders Via Smart Phones - PILOT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02205177
• Other study ID #: 13-000288 - PILOT
• Secondary ID: R34MH100468
• Status: Completed
• Phase: N/A
• Start date: January 15, 2016
• Est. completion date: March 2017

Study information

• Verified date: August 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Stephen Whiteside	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Within 5 working days of Treatment Completion
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	Within 5 working days of Treatment Completion

External Links

•   AnxietyCoach on the App Store on iTunes