Youth Mayo Clinic Anxiety Coach Pilot Study

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Age 7 to 17
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
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:
1. psychosis,
2. autism,
3. bipolar disorder,
4. mental retardation,
5. oppositional defiant disorder,
6. PTSD,
7. selective mutism, or
8. 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

Arm && Interventions

Group	Intervention	Description
Face-to-Face w/ Anxiety Coach (FTF-AC)	Mayo Clinic Anxiety Coach	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.
Minimal Contact w/ Anxiety Coach (MC-AC)	Mayo Clinic Anxiety Coach	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.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) at Treatment Completion	Within 5 working days of 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

Name	Time	Method
Number of Participants Who Completed the Subject Safety and Treatment Adherence Interview	Within 5 working days of Treatment Completion	The number of patients that completed the summary of the qualitative interview will be used to enhance Anxiety Coach