Youth Mayo Clinic Anxiety Coach Pilot Study

• Sponsor: Stephen Whiteside (Other)
• Overall Status: Completed
• CT.gov ID: NCT02205177
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 10
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Device: Mayo Clinic Anxiety Coach	N/A

Detailed Description

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. Therapist will provide CBT to patients with infrequent face-to-face contact and then will examine the acceptability, ease of use and need for contact.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Expanding Access to Therapy for Childhood Anxiety Disorders Via Smart Phones - PILOT
• Actual Study Start Date: Jan 15, 2016
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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 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; 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.
Experimental: Minimal Contact w/ Anxiety Coach (MC-AC) In this condition the therapist will meet with the patient and primary care giver for an initial 50-minute, face-to-face session to provide a tutorial on the use of Anxiety Coach. The therapist is expected to review the patient's progress via the web-based portal and communicate with the patient electronically at least once per week for a total of at least 6 and up to 12 weeks of intervention. Therapists will be allowed 2 additional face-to-face sessions if necessary and still remain in protocol.	Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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. The PARS has 5 questions. Four of those questions has a scale ranging from none (1) to extreme (5). The other question has a rating of 1-5. The total score ranges from 0 - 25, with 25 being the worst.

Secondary Outcome Measures

1. Number of Participants Who Completed the Subject Safety and Treatment Adherence Interview [Within 5 working days of Treatment Completion]

   The number of patients that completed the summary of the qualitative interview will be used to enhance Anxiety Coach

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age 7 to 17

2. Primary diagnosis of:

3. social phobia,

4. separation anxiety disorder,

5. panic disorder with and without agoraphobia,

6. specific phobia, or

7. obsessive compulsive disorder

8. A parent or other primary care giver available to participate with the child in all assessment and treatment activities

9. Estimated average intelligence

10. English speaking

Exclusion Criteria:

1. History of and/or current diagnosis of:

2. psychosis,

3. autism,

4. bipolar disorder,

5. mental retardation,

6. oppositional defiant disorder,

7. PTSD,

8. selective mutism, or

9. major depressive disorder

10. Current suicidality or recent suicidal behavior

11. Parent to be involved in study who is unable to adequately participate due to intellectual or psychiatric difficulties

12. Starting or changing the dosage of a psychiatric medication in the last two months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Stephen Whiteside
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Stephen Whiteside, PhD, LP, Mayo Clinic

Study Documents (Full-Text)

• Study Protocol - Jul 1, 2019
• Statistical Analysis Plan - Jul 1, 2019

More Information

Publications

None provided.

• Responsible Party: Stephen Whiteside, Associate Professor of Psychology, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02205177
• Other Study ID Numbers: 13-000288 - PILOT; R34MH100468
• First Posted: Jul 31, 2014
• Last Update Posted: Aug 5, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Stephen Whiteside, Associate Professor of Psychology, Mayo Clinic: Anxiety; Social Anxiety; Social Phobia; Separation Anxiety; Generalized Anxiety; GAD; Phobia; Panic; Agoraphobia; Obsessive Compulsive Disorder; OCD; Child; Adolescent; Smartphone; Teen; Youth
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

Participant Flow

Arm/Group Title	Face-to-Face w/ Anxiety Coach (FTF-AC)	Minimal Contact w/ Anxiety Coach (MC-AC)
Arm/Group Description	In this condition therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using 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, & review progress in-session via the web-based portal. 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 & patient adherence to evidence-based treatment. The design of Anxiety Coach is based on evidence & theory suggesting that information and communication technologies (ICTs) are well-suited for encouraging	In this condition the therapist will meet with the patient and primary care giver for an initial 50-minute, face-to-face session to provide a tutorial on the use of Anxiety Coach. The therapist is expected to review the patient's progress via the web-based portal and communicate with the patient electronically at least once per week for a total of at least 6 & up to 12 weeks of intervention. Therapists will be allowed 2 additional face-to-face sessions if necessary and still remain in protocol. 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 communicatio
Period Title: Overall Study
STARTED	8	2
COMPLETED	6	2
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Face-to-Face w/ Anxiety Coach (FTF-AC)	Minimal Contact w/ Anxiety Coach (MC-AC)	Total
Arm/Group Description	Therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using Anxiety Coach. The sessions occur weekly & within the office. Therapists will use Anxiety Coach at each session, encouraging patients to use the application to complete homework, & review progress in-session via the web-based portal. Mayo Clinic Anxiety Coach, a smartphone application based on cognitive-behavioral treatment for anxiety disorders can be used as a stand-alone treatment using minimal provider contact & an augmentation of face-to-face treatment that increases clinician fidelity & patient adherence to evidence-based treatment. Anxiety Coach's design is based on evidence & theory suggesting that information & communication technologies (ICTs) are well-suited for encouraging behavior change through scheduled reminders to engage in therapeutic exercises; point of performance support; individually tailored information; real-time symptom assessment & readily accessible asynchronous communication.	Therapist's will meet with the patient & parent for an initial 50-minute, face-to-face session to give a tutorial on using Anxiety Coach. The therapist will review the patient's progress via the web-based portal & communicate with patients electronically weekly for a total of 6 to 12 weeks of intervention. Mayo Clinic Anxiety Coach, a smartphone application based on cognitive-behavioral treatment for anxiety disorders can be used as a stand-alone treatment using minimal provider contact & an augmentation of face-to-face treatment that increases clinician fidelity & patient adherence to evidence-based treatment. Anxiety Coach's design is based on evidence & theory suggesting that information & communication technologies (ICTs) are well-suited for encouraging behavior change through scheduled reminders to engage in therapeutic exercises; point of performance support; individually tailored information; real-time symptom assessment & readily accessible asynchronous communication.	Total of all reporting groups
Overall Participants	8	2	10
Age (Count of Participants)
<=18 years	8 100%	2 100%	10 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	5 62.5%	2 100%	7 70%
Male	3 37.5%	0 0%	3 30%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	8 100%	2 100%	10 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) at Treatment Completion
Description	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. The PARS has 5 questions. Four of those questions has a scale ranging from none (1) to extreme (5). The other question has a rating of 1-5. The total score ranges from 0 - 25, with 25 being the worst.
Time Frame	Within 5 working days of Treatment Completion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Face-to-Face w/ Anxiety Coach (FTF-AC)	Minimal Contact w/ Anxiety Coach (MC-AC)
Arm/Group Description	In this condition therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using 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.	In this condition the therapist will meet with the patient and primary care giver for an initial 50-minute, face-to-face session to provide a tutorial on the use of Anxiety Coach. The therapist is expected to review the patient's progress via the web-based portal and communicate with the patient electronically at least once per week for a total of at least 6 and up to 12 weeks of intervention. Therapists will be allowed 2 additional face-to-face sessions if necessary and still remain in protocol.
Measure Participants	8	2
Mean (Standard Deviation) [score on a scale]	11 (3.1)	-1 (.7)

2. Secondary Outcome

Title	Number of Participants Who Completed the Subject Safety and Treatment Adherence Interview
Description	The number of patients that completed the summary of the qualitative interview will be used to enhance Anxiety Coach
Time Frame	Within 5 working days of Treatment Completion

Outcome Measure Data

Analysis Population Description

No families from minimal contact responded to interview request. three of the families from the Face to Face condition did not respond to invitation to interview.

Arm/Group Title	Face-to-Face w/ Anxiety Coach (FTF-AC)	Minimal Contact w/ Anxiety Coach (MC-AC)
Arm/Group Description	In this condition therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using 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.	In this condition the therapist will meet with the patient and primary care giver for an initial 50-minute, face-to-face session to provide a tutorial on the use of Anxiety Coach. The therapist is expected to review the patient's progress via the web-based portal and communicate with the patient electronically at least once per week for a total of at least 6 and up to 12 weeks of intervention. Therapists will be allowed 2 additional face-to-face sessions if necessary and still remain in protocol.
Measure Participants	5	0
Count of Participants [Participants]	5 62.5%	0 0%

Adverse Events

Time Frame	11 months
Arm/Group Title	Face-to-Face w/ Anxiety Coach (FTF-AC)		Minimal Contact w/ Anxiety Coach (MC-AC)
Arm/Group Description	Therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using Anxiety Coach. The sessions occur weekly & within the office. Therapists will use Anxiety Coach at each session, encouraging patients to use the application to complete homework, & review progress in-session via the web-based portal. Mayo Clinic Anxiety Coach, a smartphone application based on cognitive-behavioral treatment for anxiety disorders can be used as a stand-alone treatment using minimal provider contact & an augmentation of face-to-face treatment that increases clinician fidelity & patient adherence to evidence-based treatment. Anxiety Coach's design is based on evidence & theory suggesting that information & communication technologies (ICTs) are well-suited for encouraging behavior change through scheduled reminders to engage in therapeutic exercises; point of performance support; individually tailored information; real-time symptom assessment & readily accessible asynchronous communication.		Therapist's will meet with the patient & parent for an initial 50-minute, face-to-face session to give a tutorial on using Anxiety Coach. The therapist will review the patient's progress via the web-based portal & communicate with patients electronically weekly for a total of 6 to 12 weeks of intervention. Mayo Clinic Anxiety Coach, a smartphone application based on cognitive-behavioral treatment for anxiety disorders can be used as a stand-alone treatment using minimal provider contact & an augmentation of face-to-face treatment that increases clinician fidelity & patient adherence to evidence-based treatment. Anxiety Coach's design is based on evidence & theory suggesting that information & communication technologies (ICTs) are well-suited for encouraging behavior change through scheduled reminders to engage in therapeutic exercises; point of performance support; individually tailored information; real-time symptom assessment & readily accessible asynchronous communication.
All Cause Mortality
	Face-to-Face w/ Anxiety Coach (FTF-AC)		Minimal Contact w/ Anxiety Coach (MC-AC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/2 (0%)
Serious Adverse Events
	Face-to-Face w/ Anxiety Coach (FTF-AC)		Minimal Contact w/ Anxiety Coach (MC-AC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Face-to-Face w/ Anxiety Coach (FTF-AC)		Minimal Contact w/ Anxiety Coach (MC-AC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.