Anxiety
Conditions
Keywords
Anxiety, Social Anxiety, Social Phobia, Separation Anxiety, Generalized Anxiety, GAD, Phobia, Panic, Agoraphobia, Obsessive Compulsive Disorder, OCD, Child, Adolescent, Smartphone, Teen, Youth
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
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.
Interventions
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.
Sponsors
National Institute of Mental Health (NIMH)
Stephen Whiteside
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Face-to-Face w/ Anxiety Coach (FTF-AC) 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. | 8 |
| Minimal Contact w/ Anxiety Coach (MC-AC) 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. | 2 |
| Total | 10 |
Baseline characteristics
| Characteristic | Face-to-Face w/ Anxiety Coach (FTF-AC) | Minimal Contact w/ Anxiety Coach (MC-AC) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 8 Participants | 2 Participants | 10 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 2 Participants | 10 Participants |
| Sex: Female, Male Female | 5 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Male | 3 Participants | 0 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 2 |
| other Total, other adverse events | 0 / 8 | 0 / 2 |
| serious Total, serious adverse events | 0 / 8 | 0 / 2 |
Outcome results
Primary
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. 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-to-Face w/ Anxiety Coach (FTF-AC) | Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) at Treatment Completion | 11 score on a scale | Standard Deviation 3.1 |
| Minimal Contact w/ Anxiety Coach (MC-AC) | Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) at Treatment Completion | -1 score on a scale | Standard Deviation 0.7 |
Secondary
Number of Participants Who Completed the Subject Safety and Treatment Adherence Interview
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Face-to-Face w/ Anxiety Coach (FTF-AC) | Number of Participants Who Completed the Subject Safety and Treatment Adherence Interview | 5 Participants |
| Minimal Contact w/ Anxiety Coach (MC-AC) | Number of Participants Who Completed the Subject Safety and Treatment Adherence Interview | 0 Participants |