Examining the Feasibility of a Mobile Mental Health Application (Rose) for Augmentation of In-person Psychotherapy
Trial ID: NCT04200170
Status: UNKNOWN
Study type: INTERVENTIONAL
Phase: NA
Start date: 2019-08-01
Completion date: 2019-12-27
Sponsor: Ask Rose
Conditions: Mental Health Wellness 1; Depression
Interventions: Rose
Locations: Key Point Health Services
Countries: United States
Enrollment: 45
Age range: 18 Years - None
Sex: ALL

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.

Eligibility criteria:
Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Outcomes:
Average weekly completion rate for Mood check-in; Average weekly completion rate for Anxiety check-in; Average weekly completion rate for online journaling; Adherence to Patient Health Questionnaire-9 (PHQ-9) survey completion at Baseline; Adherence to Patient Health Questionnaire-9 (PHQ-9) survey completion at Week 2; Adherence to General Anxiety Disorder-7 (GAD-7) survey completion at Week 4; 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; Assess objective and subjective quality of mobile app used