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Youth Mayo Clinic Anxiety Coach Randomized Controlled Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02205203
Enrollment
145
Registered
2014-07-31
Start date
2019-01-01
Completion date
2021-03-01
Last updated
2021-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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

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).

Interventions

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.

OTHERTreatment 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).

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Stephen Whiteside
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean change from Baseline in Pediatric Anxiety Rating Scale (PARS) at Treatment CompletionWithin 5 working days of Treatment CompletionThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026