Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05776901
Status:
TERMINATED
Last Update Posted:
2023-09-15
First Post:
2023-02-28
Brief Title:
C-STRESS A Mental Health App for College Students With Depression
Sponsor:
Benten Technologies Inc
Organization:
Benten Technologies Inc
Study Overview
Official Title:
Mobile Health mHealth Application Called CBCT Sessions to Treat and Reduce Elevated Stress Among Students C-STRESS
Status:
TERMINATED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Grant termination without continuation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
C-STRESS
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 ie 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-STRESSs usabilityfeasibility and changes in depressive symptoms and coping styles over the study period
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 ie 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-STRESSs usabilityfeasibility and changes in depressive symptoms and coping styles over the study period
Detailed Description:
More than half of US 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 populations 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 reasons 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 meditationreflectionjournaling 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-STRESSs usabilityfeasibility and changes in depressive symptoms and coping styles over the 6-week study period
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 populations 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 reasons 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 meditationreflectionjournaling 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-STRESSs usabilityfeasibility and changes in depressive symptoms and coping styles over the 6-week study period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R44MH121219 | NIH | None | httpsreporternihgovquickSearchR44MH121219 |