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

NCT05776901 | Terminated Early Phase 1 Results

• 2 other identifiers: C-STRESSR44MH121219
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Depression; Anxiety; Stress, Psychological; Mobile Phone Use

Keywords

Depression; Anxiety; Stress; mHealth; college students

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

C-STRESS DEVICE

Participants were asked to use the C-STRESS app daily for 6 weeks to participate in Cognitively Based Compassion Training (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)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benten Technologies, Inc.: lead
• University of California, Irvine: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UCI

Irvine, California, 92697, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress, Psychological; Cell Phone Use

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Communication; Social Behavior

Limitations and Caveats

The enrollment of only 3 female participants compromised the generalizability of this study in two ways. Firstly, with such a small sample size, it is challenging to draw broad conclusions regarding the usability of the C-STRESS app for the boarder population. Secondly, having an imbalanced representation of gender can limit the ability to detect potential gender-specific effects or gender differences.

Results Point of Contact

• Title: Dr. Melissa Pinto, Associate Professor, Sue & Bill Gross School of Nursing
• Organization: University of California, Irvine

mdpinto@uci.edu

949-824-9272

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

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

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 20, 2023
• Study Start: May 4, 2022
• Primary Completion: May 25, 2022
• Study Completion: May 31, 2022
• Last Updated: September 15, 2023
• Results First Posted: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)