Examining the Feasibility of the Ask RoSE Mobile Mental Health Application

NCT03909685 | Withdrawn

• 1 other identifier: IRB00206859
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Students are one of the most at-risk groups for mental illness and suicide. Up to 40% of persons with serious mental illnesses do not receive care or stop intervention programs due to negative stigma. Focusing on students, only 30% of universities provide mental health counseling as part of universities' student health services. There is an urgent need to better understand and manage the mental health burden among students. The investigators will use a mental health-focused application that utilizes artificial intelligence to identify symptoms and provides targeted, tailored in-person therapy solutions for its users. Once a patient is matched with a therapist, the application provides solutions to supplement ongoing in-person psychotherapy. This includes journaling and daily assessments that provide curated content and feedback. The current feasibility study aims to recruit 45 Johns Hopkins graduate students with at least mild depressive and/or anxiety symptoms who will be consented and enrolled in a five-week study. There are two study arms: (1) the intervention arm and (2) a waitlist control arm. During the course of the study, the participants in the intervention arm will use the application daily. Participants will receive weekly in-person psychotherapy for a total of four sessions over four weeks. Licensed therapists will provide the in-person psychotherapy. The participants in the waitlist arm will serve as controls unless there is attrition from the intervention group at which time waitlist participants will be offered a spot in the intervention arm. The primary objectives of the study are (1) To assess the usability of the application and (2) To evaluate the short-term impact on mood and anxiety of using the application to augment in-person psychotherapy.

Conditions

Mental Health Wellness 1; Anxiety

Outcome Measures

Primary Outcomes (5)

• Average session time when using the mobile app

  Over the 5 weeks of the study, the mobile app will collect time (seconds) the user spends within each session. We will calculate the average time the user spent on mobile app in each session.

  5 weeks

• Time of day the mobile app is used

  Over the 5 weeks of using the mobile app, we will capture the time of data the app was used in ( morning, afternoon and evenings). We will derive proportions for the app use at these times of day

  5 weeks

• Most commonly used feature within the app

  For each session, the app keeps track of different in-app features that are used (mood meter, journal, insights, assessments). Over the 5 week period, we will rank the most commonly used features.

  5 weeks

• Change in Short term impact on mood as assessed by the Positive and Negative Emotions Scale (PANAS)

  The PANAS is a self-report questionnaire that consists of two 1-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).

  Baseline, 5 weeks

• Change in Short term impact on anxiety as assessed by the General Anxiety Disorder-7 (GAD-7) scale

  The GAD-7 is a self-administered 7 item instrument that uses some of the DSM-V criteria for anxiety to identify probable cases of GAD along with measuring anxiety symptom severity. Responders are asked to rate the frequency of anxiety symptoms in the last 2 weeks on a Likert scale ranging from 0-3.Severity can be determined by examining the total score. A meaningful change is 5 or more points.

  Baseline, 5 weeks

Study Arms (2)

the intervention arm

EXPERIMENTAL

During the course of the study, the participants in the intervention arm will use the Ask RoSE application daily. Participants will receive weekly in-person psychotherapy for a total of four sessions over four weeks. Licensed therapists will provide the in-person psychotherapy

Behavioral: Mobile Mental Health App

a waitlist control arm

NO INTERVENTION

The participants in the waitlist arm will serve as controls unless there is attrition from the intervention group at which time waitlist participants will be offered a spot in the intervention arm

Interventions

Mobile Mental Health App BEHAVIORAL

The Mobile Mental Health App is an app that utilizes artificial intelligence to identify symptoms and provides targeted, tailored solutions for its users.

the intervention arm

Eligibility Criteria

• Age: 21 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• English speaking;
• years of age;
• Full time Johns Hopkins University graduate student;
• Score \>5 on PHQ-9 and/or \>5 on GAD-7;
• Have accessible smartphone with data plan;
• Ability to dedicate one hour a week for therapy sessions;
• Ability to give informed consent and understand the tasks involved.

You may not qualify if:

• Not living in Baltimore or surrounding counties as this will make it difficult to schedule on-campus therapy sessions;
• Part-time students;
• Students currently receiving psychiatric care.

Sponsors & Collaborators

• Johns Hopkins University: lead

Related Publications (7)

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  PMID: 27484622 BACKGROUND

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  PMID: 29642471 BACKGROUND

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  PMID: 29967780 BACKGROUND

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  PMID: 30356496 BACKGROUND

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  PMID: 27187854 BACKGROUND

• Allan NP, Lonigan CJ, Phillips BM. Examining the Factor Structure and Structural Invariance of the PANAS Across Children, Adolescents, and Young Adults. J Pers Assess. 2015;97(6):616-25. doi: 10.1080/00223891.2015.1038388. Epub 2015 May 15.

  PMID: 25975209 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Paul Kim, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The current study aims to recruit 45 Johns Hopkins graduate students (initially from Carey Business School) with at least mild depressive and/or anxiety symptoms who will be consented and enrolled in a five-week study. There are two study arms: (1) the intervention arm and (2) a waitlist control arm. During the course of the study, the participants in the intervention arm will use the Ask RoSE application daily. Participants will receive weekly in-person psychotherapy for a total of four sessions over four weeks. Licensed therapists will provide the in-person psychotherapy. The participants in the waitlist arm will serve as controls unless there is attrition from the intervention group at which time waitlist participants will be offered a spot in the intervention arm.

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: July 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 26, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share