Youth Mayo Clinic Anxiety Coach Randomized Controlled Trial

NCT ID: NCT02205203

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-03-01

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).

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Face-to-Face w/ Anxiety Coach (FTF-AC)

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.

Group Type: ACTIVE_COMPARATOR

Mayo Clinic Anxiety Coach

Intervention Type: 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 (TAU)

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.

Group Type: EXPERIMENTAL

Treatment as Usual

Intervention Type: 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).

Interventions

Mayo Clinic Anxiety Coach

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.

Intervention Type: DEVICE

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Stephen Whiteside

OTHER

Sponsor Role: lead

Responsible Party

Stephen Whiteside

Professor of Psychology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stephen Whiteside, Ph.D., L.P.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37209422 (View on PubMed)

Other Identifiers

R34MH100468

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-000288 - RCT

Identifier Type: -

Identifier Source: org_study_id