Examining the Feasibility of a Mobile Mental Health Application in Psychotherapy

NCT04200170 | Unknown FDA Device

• 1 other identifier: rose001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

There is an urgent need to better understand and manage the mental health burden among working adults. Up to 40% of persons with serious mental illnesses do not receive care or stop intervention programs due to negative stigma. Additionally, nearly 50 percent of respondents diagnosed with an anxiety disorder said it interfered with their relationships with coworkers. Close to $6000 USD is lost per working person each year due to depression and its effects. Rose (Recognition of Speech and Emotion) is a mental health-focused application that utilizes artificial intelligence to identify symptoms and provides targeted, tailored in-person therapy solutions for its users. The RoSE 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 established outpatients with at least mild depressive and/or anxiety symptoms who will be consented and enrolled in a five to ten-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 RoSE application daily. They will receive either weekly in-person psychotherapy with their established psychotherapist for a total of four sessions over four weeks or biweekly in-person psychotherapy with their established psychotherapist for a total of four sessions over eight weeks. 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 RoSE application and (2) To evaluate the short-term impact on mood and anxiety of using the RoSE application to augment in-person psychotherapy. The secondary objectives are (1) To examine the usage and utility of an in-application journaling function and (2) To examine the usage and utility of in-application curated insights.

Conditions

Mental Health Wellness 1; Depression

Keywords

mobile health

Outcome Measures

Primary Outcomes (10)

• Average weekly completion rate for Mood check-in

  Over the study period, the mobile app will collect time (date/time) the user fills in the Mood Likert Scale. We will calculate the average number of times the user fills in the scale each week.

  4 weeks

• Average weekly completion rate for Anxiety check-in

  Over the study period, the mobile app will collect time (date/time) the user fills in the Anxiety Likert Scale. We will calculate the average number of times the user fills in the scale each week.

  4 weeks

• Average weekly completion rate for online journaling

  Over the study period, the mobile app will collect time (date/time) the user fills the online journal. We will calculate the average number of times the user fills in the scale each week.

  4 weeks

• Adherence to Patient Health Questionnaire-9 (PHQ-9) survey completion at Baseline

  Over the study period, the mobile app will prompt the user to fill in the PHQ-9 survey. The app will collect time (date/time) the user fills this in. We will record the level of adherence: Full ( Baseline filled) vs. Partial (Baseline not filled)

  Baseline

• Adherence to Patient Health Questionnaire-9 (PHQ-9) survey completion at Week 2

  Over the study period, the mobile app will prompt the user to fill in the PHQ-9 survey. The app will collect time (date/time) the user fills this in. We will record the level of adherence: Full ( Week 2 filled) vs. Partial (Week 2 not filled)

  Week 2

• Adherence to General Anxiety Disorder-7 (GAD-7) survey completion at Week 4

  Over the study period, the mobile app will prompt the user to fill in the PHQ-9 survey. The app will collect time (date/time) the user fills this in. We will record the level of adherence: Full ( Week 4 filled) vs. Partial (Week 4 not filled)

  Week 4

• Adherence to General Anxiety Disorder-7 (GAD-7) survey completion at Baseline

  Over the study period, the mobile app will prompt the user to fill in the GAD-7 survey. The app will collect time (date/time) the user fills this in. We will record the level of adherence: Full ( Baseline filled) vs. Partial (Baseline not filled)

  Baseline

• Adherence to General Anxiety Disorder-7 (GAD-7) survey completion at Week 2

  Over the study period, the mobile app will prompt the user to fill in the GAD-7 survey. The app will collect time (date/time) the user fills this in. We will record the level of adherence: Full ( Week 2 filled) vs. Partial (Week 2 not filled)

  Week 2

• Adherence to General Anxiety Disorder-7 (GAD-7) survey completion at Week 4

  Over the study period, the mobile app will prompt the user to fill in the GAD-7 survey. The app will collect time (date/time) the user fills this in. We will record the level of adherence: Full ( Week 4 filled) vs. Partial (Week 4 not filled)

  Week 4

• Assess objective and subjective quality of mobile app used

  At the end of the study (week 5), participants will be asked to complete the Mobile Application Rating Scale (MARS) to score the intervention app on the criteria of engagement, functionality, aesthetics, and information quality, as well as app subjective quality. Each MARS item used a 5-point scale (1-Inadequate, 2-Poor, 3-Acceptable, 4-Good, 5-Excellent). The MARS is calculated as mean scores of the engagement, functionality, aesthetics, and information quality objective sub-scales, and an overall mean app quality total score.

  Week 5

Secondary Outcomes (2)

• Change in Short term impact on anxiety as assessed by the GAD-7

  Baseline, 4 weeks

• Change in Short term impact on anxiety as assessed by the PHQ-9

  Baseline, 4 weeks

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Eligible participants had been scheduled for either weekly or biweekly sessions with their therapists. Participants in the intervention arm were asked to download the Rose application on to their personal mobile phones and were given their therapist's unique ID for verification in the app. During the first week of the study, participants were prompted to complete key surveys and assessments at predetermined time intervals. Participants seen weekly will use the app for a total of 5 weeks and receive weekly in-person therapy for a total of 4 weeks (one-week application only lead-in, four weeks application plus in-person psychotherapy). Participants seen biweekly will use the app for a total of 10 weeks and receive biweekly in-person therapy for a total of 8w weeks (two-week application only lead-in, eight weeks application plus in-person psychotherapy).

Device: Rose

Waitlist Control Arm

NO INTERVENTION

The participants in the waitlist control arm served as controls for the study. They completed the pre-pilot and post-pilot assessments only. The waitlist participants continued their standard care and were offered entrance to the intervention arm at the end of the study period or earlier if patients in the intervention arm dropped out mid-study. During their time on the waitlist, participants could reach out to study personnel if they needed assistance with their psychiatric care.

Interventions

Rose DEVICE

Rose is a patient-centric, mobile mental health platform designed for in-between clinical mental health monitoring in form of mood tracking, clinical surveys and daily journaling. Rose is used as a participant-facing mobile app and clinician-facing dashboard. Each day, they complete mood and anxiety scales and update their journals. Biweekly, they are also asked to complete the PHQ-9 and GAD-7 assessments as well. The Rose mobile app sends timely self-help articles and notifications for users. The curated insights are selected based on participant responses to the daily mood and anxiety surveys, as well as a built-in sentiment analysis of the journaling. The clinical dashboard is a secure, web-based portal that has a unique login for each provider. Providers have access to only their patients through the system and are able to see all the health metrics collected with the Rose mobile app and the summarized metrics produced by our models.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking;
• \>=18 years of age;
• Score \>5 on PHQ-9 and/or \>5 on GAD-7;
• Have an accessible smartphone with a 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:

• Current psychosis (e.g., hallucinations, delusions, thought disorder);
• Current suicidal ideation or homicidal ideation

Sponsors & Collaborators

• Ask Rose: lead

Study Sites (1)

Key Point Health Services

Baltimore, Maryland, 21224, United States

Location

Related Publications (4)

• Economides M, Ranta K, Nazander A, Hilgert O, Goldin PR, Raevuori A, Forman-Hoffman V. Long-Term Outcomes of a Therapist-Supported, Smartphone-Based Intervention for Elevated Symptoms of Depression and Anxiety: Quasiexperimental, Pre-Postintervention Study. JMIR Mhealth Uhealth. 2019 Aug 26;7(8):e14284. doi: 10.2196/14284.

  PMID: 31452521 BACKGROUND

• Goldin PR, Lindholm R, Ranta K, Hilgert O, Helteenvuori T, Raevuori A. Feasibility of a Therapist-Supported, Mobile Phone-Delivered Online Intervention for Depression: Longitudinal Observational Study. JMIR Form Res. 2019 Jan 22;3(1):e11509. doi: 10.2196/11509.

  PMID: 30682726 RESULT

• Giosan C, Cobeanu O, Mogoase C, Szentagotai A, Muresan V, Boian R. Reducing depressive symptomatology with a smartphone app: study protocol for a randomized, placebo-controlled trial. Trials. 2017 May 12;18(1):215. doi: 10.1186/s13063-017-1960-1.

  PMID: 28494802 RESULT

• Adam A, Jain A, Pletnikova A, Bagga R, Vita A, N Richey L, Gould N, Munshaw S, Misrilall K, Peters ME. Use of a Mobile App to Augment Psychotherapy in a Community Psychiatric Clinic: Feasibility and Fidelity Trial. JMIR Form Res. 2020 Jul 3;4(7):e17722. doi: 10.2196/17722.

  PMID: 32618572 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Ameena Jain

  Key Point Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The current study aims to recruit 45 patients with at least mild depressive and/or anxiety symptoms who will be consented and enrolled in a five-week study.The consented participants will be randomized to one of the two study arms: (1) the intervention arm or (2) the waitlist control arm in a 2:1 ratio. During the course of the study, the participants in the intervention arm will use the mental health 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: December 11, 2019
• First Posted: December 16, 2019
• Study Start: August 1, 2019
• Primary Completion: November 29, 2019
• Study Completion: December 27, 2019
• Last Updated: December 16, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)