Youth Mayo Clinic Anxiety Coach Randomized Controlled Trial

NCT02205203 | Completed

• 2 other identifiers: 13-000288 - RCTR34MH100468
• Study Type: interventional
• Target: 145
• 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.

  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 Mayo Clinic 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

Treatment as Usual (TAU)

EXPERIMENTAL

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). Therapists can communicate with patients between sessions (e.g., phone calls), as long as this medium is not the primary mode of treatment.

Other: Treatment as Usual

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)

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).

Treatment as Usual (TAU)

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

Related Publications (1)

• Whiteside SPH, Sawchuk NR, Brennan E, Lebow JR, Sawchuk CN, Biggs BK, Dammann JE, Tiede MS, Hofschulte DR, Reneson-Feeder S, Cunningham M, Allison ML. Using session recordings to understand the content of community-based treatment for childhood anxiety disorders and response to technology-based training. J Clin Psychol. 2023 Oct;79(10):2251-2269. doi: 10.1002/jclp.23537. Epub 2023 May 20.

  PMID: 37209422 DERIVED

MeSH Terms

Conditions

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

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders; Neurodevelopmental Disorders

Study Officials

• Stephen Whiteside, Ph.D., L.P.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: July 31, 2014
• Study Start: January 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: March 1, 2021
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)