Youth Mayo Clinic Anxiety Coach Randomized Controlled Trial

N/ACompletedNCT02205203

Stephen Whiteside145 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

145

Conditions

Anxiety

Interventions

Mayo Clinic Anxiety CoachDEVICE

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.

Treatment as UsualOTHER

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).

Eligibility

Sex: ALLMin age: 7 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: Within 5 working days of Treatment Completion

Data from ClinicalTrials.gov

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