Trial Outcomes & Findings for C-STRESS: A Mental Health App for College Students With Depression (NCT NCT05776901)

Last Updated: 2023-09-15

Results Overview

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.

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

3 participants

Primary outcome timeframe

Baseline, week 3

Results posted on

2023-09-15

Participant Flow

Participants were recruited via print, email, or electronic posting of flyer on UCI websites or affiliated social media and locations in and around UCI campus from March 16 to May 31, 2022. All three participants were enrolled on May 04, 2022. Due to grant termination, final collection of data for the primary outcome was on May 25, 2022, which allowed us to collect data at baseline and week 3, but not perform data collection at week 6 due to grant termination.

All participants were assigned to the C-STRESS arm. Participants who reported active suicidal ideation and female students who self-reported pregnant or plans to become pregnant within the next 3 months were excluded.

Participant milestones

Participant milestones
Measure	C-STRESS 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)
Overall Study STARTED	3
Overall Study Week 3	3
Overall Study Week 6	0
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	C-STRESS 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)
Overall Study Covid delays and grant termination without continuation.	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	C-STRESS n=3 Participants 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)
Age, Continuous	24.67 years STANDARD_DEVIATION 1.89 • n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	3 participants n=99 Participants
System Usability Scale	54.58 score on a scale STANDARD_DEVIATION 20.59 • n=99 Participants

PRIMARY outcome

Timeframe: Baseline, week 3

Outcome measures

Outcome measures
Measure	C-STRESS n=3 Participants 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)
Change From Baseline System Usability Scale Scores at Week 3 and Week 6 Milestone 1 (week 1): Completion of the C-STRESS app orientation session and the SUS questionnaire	71.67 score on a scale Standard Deviation 11.61
Change From Baseline System Usability Scale Scores at Week 3 and Week 6 Milestone 2: Completion of the SUS questionnaire at week 3	37.5 score on a scale Standard Deviation 11.37
Change From Baseline System Usability Scale Scores at Week 3 and Week 6 Change from baseline SUS scores at week 3	34.17 score on a scale Standard Deviation 20.45

Adverse Events

C-STRESS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Melissa Pinto, Associate Professor, Sue & Bill Gross School of Nursing

University of California, Irvine

Phone: 949-824-9272

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place