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Intervention Arm for Depression

N/A
Waitlist Available
Led By Ameena Jain
Research Sponsored by Ask Rose
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Mental Health Wellness
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence to General Anxiety Disorder-7 (GAD-7) survey completion at Baseline
Adherence to General Anxiety Disorder-7 (GAD-7) survey completion at Week 2
Adherence to General Anxiety Disorder-7 (GAD-7) survey completion at Week 4
+6 more
Secondary study objectives
Change in Short term impact on anxiety as assessed by the GAD-7
Change in Short term impact on anxiety as assessed by the PHQ-9

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
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).
Group II: Waitlist Control ArmActive Control1 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.

Find a Location

Who is running the clinical trial?

Ask RoseLead Sponsor
Ameena JainPrincipal InvestigatorKey Point Health Services
~7 spots leftby Nov 2025