Youth Mayo Clinic Anxiety Coach Randomized Controlled Trial

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02205203
• Other study ID #: 13-000288 - RCT
• Secondary ID: R34MH100468
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• 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:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: March 1, 2021
• Est. primary completion date: June 1, 2020
• 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.

Other:
• Treatment as Usual
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).

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.	Within 5 working days of Treatment Completion

External Links

•   Mayo Clinic Clinical Trials