DepressionEarly Phase 1C-STRESSNCT05776901
C-STRESS: A Mental Health App for College Students With Depression
A Early Phase 1 study testing C-STRESS in people with Depression and Anxiety, run by Benten Technologies, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Depression, Anxiety, Stress, Psychological
- What is being tested?
- C-STRESS
- Type of treatment
- Medical device
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2022to 31 May 2022
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression, Anxiety, Stress, Psychological, Mobile Phone Use
- Being tested
- C-STRESS
- Keywords
- Depression, Anxiety, Stress, mHealth, college students
- Medical subject headings
- Depression, Anxiety Disorders, Stress, Psychological, Cell Phone Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-STRESSDevice
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start4 May 2022
- Primary completion25 May 2022
- Study completion31 May 2022
Why it stopped: Grant termination without continuation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants enrolled in the study were asked to use the C-STRESS app daily for 6 weeks.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benten Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Tony Ma, Benten Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776901
- Sponsor's protocol ID
- C-STRESS
- Other IDs
- R44MH121219
- Acronym
- C-STRESS
- Status last verified
- Sep 2023
- First submitted
- 28 Feb 2023
- Last updated
- 15 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health (mHealth) Application Called CBCT Sessions to Treat and Reduce Elevated Stress Among Students (C-STRESS)
- ClinicalTrials.gov ID
- NCT05776901
- Acronym / sponsor ID
- C-STRESS / C-STRESS
- Conditions
- Depression, Anxiety, Stress, Psychological, Mobile Phone Use
- Keywords
- Depression, Anxiety, Stress, mHealth, college students
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Grant termination without continuation.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Benten Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of California, Irvine, National Institute of Mental Health (NIMH)
- Study start
- 4 May 2022 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Posted 15 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- All participants enrolled in the study were asked to use the C-STRESS app daily for 6 weeks.
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-STRESSParticipants 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) | Device | – |
Primary outcome
Change From Baseline System Usability Scale Scores at Week 3 and Week 6
Time frame: Baseline, week 3
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing C-STRESS in people with Depression and Anxiety, run by Benten Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline System Usability Scale Scores at Week 3 and Week 6 (time frame: Baseline, week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.