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Completed

NCT Number: NCT02205203

Youth Mayo Clinic Anxiety Coach Randomized Controlled Trial

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.

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Key information

Conditions

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

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Treatment as Usual

Other

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).

Primary outcomes

  1. Mean change from Baseline in Pediatric Anxiety Rating Scale (PARS) at Treatment Completion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stephen Whiteside

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jul 31, 2014
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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