Pilot Testing C-STRESS: A Mental Health App for College Students With Depression

Sponsor

Benten Technologies, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT05776901

Collaborator

University of California, Irvine (Other)

Enrollment

Location

Actual Duration (Days)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this pilot study is to examine the feasibility of the prototype C-STRESS app with 3 college students from UCI with clinically significant depression (scored ≥ 10 on the PHQ-9). The main question it aims to answer is: whether the prototype C-STRESS is useful for college students to manage daily stress and depression symptoms.

Participants were asked to use the C-STRESS app daily for 6 weeks to participate in CBCT lessons, watch guided meditation videos, complete short reflective exercises, and engage with other content provided in C-STRESS (i.e., attending drop-in sessions, journaling, completing mood and wellbeing check-ins, and reading educational articles on depression, anxiety, and stress). At the end of week 3 and 6, participants completed 6 online surveys (SUS, TAM, PHQ9, GAD7, CDC HRQOL4, and Brief-COPE) to assess C-STRESS's usability/feasibility and changes in depressive symptoms and coping styles over the study period.

Condition or Disease	Intervention/Treatment	Phase
Depression Anxiety Stress, Psychological Mobile Phone Use	Device: C-STRESS	Early Phase 1

Detailed Description

More than half of U.S. college students experience significant symptoms of depression, anxiety or stress, and three-fourths of these college students do not obtain professional help due to overburdened mental health services at universities and colleges. Prevalence of mental disorders and inadequate utilization of mental health services is a particularly severe problem for minority students and community college students. CBCT has been administered to a variety of populations, including college students (undergraduate students, medical school students) and younger adolescents in prior completed studies, that collectively showed that CBCT can significantly strengthen cognitive resilience to stress and substantially reduce depressive symptoms, stress-associated systemic inflammation, improve emotional regulation (including impulse control) and mindfulness; increase compassion, and improve empathetic accuracy (measured by fMRI) - a critical skill that aims at cultivating relationships and connection to others. Currently, as a face-to- face program, CBCT certification at Emory takes 1 year to complete, and there are only 48 CBCT instructors. Due to the course duration, location, and time-intensive requirement for certification, CBCT has limited reach and scalability in its current instructional model despite growing demands.

The research team developed C-STRESS, a digital treatment intervention that leverages an evidence-based intervention named Cognitively-Based Compassion Training (CBCT). C-STRESS adapts the traditional intervention modality (face-to-face) of CBCT in the form of microlearning and provides personalization options including virtual companions and an animated visual cue of growing a garden to promote student engagement. Using co-design sessions with college students, the research team developed other features in C-STRESS to address the target population's needs when it comes to using a mobile app for mental health care, including an audiovisual library of guided meditation and resources, journaling, virtual drop-ins with CBCT instructors, mood and wellbeing tracking, and crisis helpline.

The research team recruited an independent convenience sample of 3 UCI undergraduate and graduate students to pilot test the initial content (onboarding and modules 0-3) of the prototype C-STRESS mobile application. Participants completed measures via REDCap (Demographic Questionnaire, PHQ9, GAD7, Brief-COPE, CDC HRQOL4). Once enrolled, participants met with a member of the research team via Zoom to a) download the prototype app, b) complete app onboarding (eg. indicate reason(s) for using the app, indicate color scheme & frequency of notification preferences, select avatar if desired, etc.), c) begin to explore the app and its functionality with a research team member available to provide technical assistance, and

complete the SUS and TAM questionnaires via REDCap survey link. After the onboarding, participants were asked to use the prototype C-STRESS application at least once per day for 6 weeks. Daily usage ranged from approximately 2 minutes (opening the app and performing a one-minute meditation) to as much time as the participant desires (opening the app, completing available content, and unlimited meditation/reflection/journaling, etc. multiple times per day). At the end of week 3 (timepoint 1) and week 6 (timepoint 2) the participants were asked to complete measures (PHQ9, GAD7, Brief-COPE, CDC HRQoL, SUS, TAM) via REDCap survey to assess C-STRESS's usability/feasibility and changes in depressive symptoms and coping styles over the 6-week study period.

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

All participants enrolled in the study were asked to use the C-STRESS app daily for 6 weeks.All participants enrolled in the study were asked to use the C-STRESS app daily for 6 weeks.

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

mHealth Application Called CBCT Sessions to Treat and Reduce Elevated Stress Among Students (C-STRESS)

Actual Study Start Date :

May 4, 2022

Actual Primary Completion Date :

May 31, 2022

Actual Study Completion Date :

May 31, 2022

Outcome Measures

Primary Outcome Measures

Change from Baseline System Usability Scale scores at Week 3 and 6 [Baseline, week 3, week 6]
The System Usability Scale is a reliable assessment tool for evaluating the usability of a product or service. The scale comprises ten questions, each with five possible responses, ranging from 1 (Strongly disagree) to 5 (Strongly agree). A higher score on the System Usability Scale indicates a higher level of usability.

Secondary Outcome Measures

Change from Baseline Technology Acceptance Model scores at Week 3 and 6 [Baseline, week 3, week 6]
The Technology Acceptance Model is a reliable assessment tool for evaluating the acceptability of a product or service. Technology Acceptance Model comprises fifty questions, each with seven possible responses, ranging from 1 (Strongly disagree) to 7 (Strongly agree). A higher score on the Technology Acceptance Model indicates a higher level of acceptability.
Change from Baseline Patient Health Questionnaire 9 scores at Week 3 and 6 [Baseline, week 3, week 6]
The Patient Health Questionnaire 9 is a reliable assessment tool for assessing symptoms of depression. The questionnaire comprises nine questions, each with four possible responses, ranging from 0 (Not at all) to 3 (Nearly every day). A higher score on the Patient Health Questionnaire 9 indicates a greater severity of depressive symptoms.
Change from Baseline General Anxiety Disorder 7 scores at Week 3 and 6 [Baseline, week 3, week 6]
The Generalized Anxiety Disorder 7 is a reliable assessment tool for assessing symptoms of generalized anxiety disorder. The questionnaire comprises seven questions, each with four possible responses, ranging from 0 (Not at all) to 3 (Nearly every day). A higher score on the Generalized Anxiety Disorder 7 indicates a greater severity of anxiety symptoms.
Change from Baseline Healthy Days Core Module scores at Week 3 and 6 [Baseline, week 3, week 6]
The Healthy Days Core Module is a reliable assessment tool for assessing the general health status and health-related quality of life of adults. The questionnaire consists of four questions. Question 1 has five response options, ranging from 1 (excellent) to 5 (poor). Responses to questions 2-4 are recorded as the number of days, ranging from 0 to 30. A higher total score on the Healthy Days Core Module indicates a poorer health-related quality of life of adults.
Change from Baseline Coping Orientation to Problems Experienced Inventory scores at week 3 and 6 [Baseline, week 3, week 6]
Coping Orientation to Problems Experienced Inventory (Brief-COPE) is a reliable assessment tool for assessing coping strategies and responses to stress. The questionnaire comprises 28 questions, each with four possible responses, ranging from 1 (I haven't been doing this at all) to 4 (I've been doing this a lot). A higher score on the Coping Orientation to Problems Experienced Inventory indicates more frequent use of the coping strategies assessed by the inventory, which does not necessarily indicate better or worse coping.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Undergraduate or graduate students
Enrolled at University of California Irvine (UCI)
Between the ages of 18-30
Speak and understand English
Have access to the internet for 6 weeks to participate in study activities via Zoom
Report clinically significant depression (scores ≥ 10 on the PHQ-9)
Have a smartphone with either iOS or android operating system

Exclusion Criteria:

Report active suicidal ideation unless they obtain a written note of approval from a psychiatric provider
Female student who self-report pregnancy or plans to become pregnant within the next 3 months