Youth Mayo Clinic Anxiety Coach Pilot Study

NCT02205177 | Completed Results

• 2 other identifiers: 13-000288 - PILOTR34MH100468
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

Anxiety; Social Anxiety; Social Phobia; Separation Anxiety; Generalized Anxiety; GAD; Phobia; Panic; Agoraphobia; Obsessive Compulsive Disorder; OCD; Child; Adolescent; Smartphone; Teen; Youth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants Who Completed the Subject Safety and Treatment Adherence Interview

  Within 5 working days of Treatment Completion

Study Arms (2)

Face-to-Face w/ Anxiety Coach (FTF-AC)

ACTIVE COMPARATOR

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.

Device: Mayo Clinic Anxiety Coach

Minimal Contact w/ Anxiety Coach (MC-AC)

EXPERIMENTAL

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.

Device: Mayo Clinic Anxiety Coach

Interventions

Mayo Clinic Anxiety Coach 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.

Face-to-Face w/ Anxiety Coach (FTF-AC); Minimal Contact w/ Anxiety Coach (MC-AC)

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stephen Whiteside: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Phobia, Social; Anxiety, Separation; Generalized Anxiety Disorder; Phobic Disorders; Agoraphobia; Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Neurodevelopmental Disorders

Results Point of Contact

• Title: Stephen P Whiteside, PhD, LP
• Organization: Mayo Clinic

Whiteside.Stephen@mayo.edu

507-284-2933

Study Officials

• Stephen Whiteside, PhD, LP

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: July 31, 2014
• Study Start: January 15, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: August 5, 2019
• Results First Posted: August 5, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)