C-STRESS: A Mental Health App for College Students With Depression (C-STRESS)

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

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 Patient Health Questionnaire-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 (System Usability Scale, Technology Acceptance Model, Patient Health Questionnaire-9, General Anxiety Disorder-7, Health Related Quality of Life-4, and Brief-COPE) to assess C-STRESS's usability/feasibility and changes in depressive symptoms and coping styles over the study period.

Study Overview

• Status: Terminated
• Conditions: Depression; Stress, Psychological; Anxiety; Mobile Phone Use
• Intervention / Treatment: Device: C-STRESS

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. Cognitively Based Compassion Training (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 CBCT to improve the mental health of college students. C-STRESS adapts the traditional intervention modality (face-to-face) of CBCT in the form of micro-learning 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 (introduction and modules 0-3) of the prototype C-STRESS mobile application. Participants completed measures via REDCap. Once enrolled, participants met with a member of the research team via Zoom to a) download the prototype app, b) complete app orientation (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 d) complete the System Usability Scale and Technology Acceptance Model questionnaires via REDCap survey link. After the app orientation, 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 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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • UCI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Patient Health Questionnaire-9)
• Have a smart phone with either iPhone Operating System (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline System Usability Scale Scores at Week 3 and Week 6	The System Usability Scale (SUS) is a reliable assessment tool for evaluating the perceived usability and ease of use of a product or service. The scale comprises ten questions, each with five possible responses, ranging from 1 (Strongly disagree) to 5 (Strongly agree). The participant's response to each question is converted to a score, added together and then multiplied by 2.5 to convert their original responses to a score of 0-100. A higher score indicates higher perceived usability and ease of use of a product or service. SUS was assessed at both the baseline and week 3. However, there was no assessment of SUS in week 6 due to grant termination.	Baseline, week 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Technology Acceptance Model scores at Week 3 and 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.	Baseline, week 3, week 6
Change from Baseline Patient Health Questionnaire 9 scores at Week 3 and 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.	Baseline, week 3, week 6
Change from Baseline General Anxiety Disorder 7 scores at Week 3 and 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.	Baseline, week 3, week 6
Change from Baseline Healthy Days Core Module scores at Week 3 and 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.	Baseline, week 3, week 6
Change from Baseline Coping Orientation to Problems Experienced Inventory scores at week 3 and 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.	Baseline, week 3, week 6

Collaborators and Investigators

• Sponsor: Benten Technologies, Inc.
• Collaborators: National Institute of Mental Health (NIMH); University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2022
• Primary Completion (Actual): May 25, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Stress; mHealth; college students
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Stress, Psychological
• Other Study ID Numbers: C-STRESS; R44MH121219 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No