Youth Mayo Clinic Anxiety Coach Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Device: Mayo Clinic Anxiety Coach; Other: Treatment as Usual

• Registration Number: NCT02205203
• Lead Sponsor: Stephen Whiteside

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).

Study Timeline

• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-07-31
• Study Start: 2019-01-01
• Primary Completion: 2020-06-01
• Status Verified: 2021-03
• Study Completion: 2021-03-01
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Face-to-Face w/ Anxiety Coach (FTF-AC)	Mayo Clinic Anxiety Coach	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.
Treatment as Usual (TAU)	Treatment 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). Therapists can communicate with patients between sessions (e.g., phone calls), as long as this medium is not the primary mode of treatment.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States