Trial Outcomes & Findings for StriveWeekly Online Mental Health Trial Post-pandemic (NCT NCT04927845)
NCT ID: NCT04927845
Last Updated: 2024-09-03
Results Overview
Change in self-reported symptoms of depression, anxiety, and stress (completed via online surveys). Items are rated on a scale of 0-3, with higher scores indicating worse symptoms. Subscale total scores range from 0-21, and DASS-21 total scores range from 0-63.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
538 participants
Primary outcome timeframe
Baseline to Posttest (~8 weeks)
Results posted on
2024-09-03
Participant Flow
Participant milestones
| Measure |
Immediate Intervention Condition
Participants in this condition will receive 7-8 weeks of online intervention modules. Specific modules will be selected based on a campus-wide needs assessment conducted in May 2021.
StriveWeekly: The intervention (app.striveweekly.com) delivers content via independent modules. Principles covered in content modules: Psychoeducation; Self-monitoring; Values-based goal-setting; Behavioral activation; Cognitive restructuring; Sleep hygiene; Time management; Interpersonal avoidance exposures; Physical exercise; Mindfulness; Relaxation strategies; Maintenance planning. Modules get released week-by-week, and participants are self-guided through content. To facilitate skills practice, every module is accompanied by: a weekly intro email and reminder emails; an "extras" section for tips/suggestions; and a weekly prize drawing. The "Dashboard" section of the intervention displays user progress, including self-rating graphs and a history log of skills practice. The "Campus" section of this dashboard provided: campus-specific announcements; referrals to relevant campus wellness resources; and an anonymous livestream of all campus users' activity.
|
Waitlist Condition
Participants in this condition will wait to receive StriveWeekly until after the Immediate Intervention condition is complete and participants from both conditions have completed the posttest survey.
|
|---|---|---|
|
Overall Study
STARTED
|
255
|
283
|
|
Overall Study
Posttest
|
149
|
241
|
|
Overall Study
2-month Follow-up
|
114
|
218
|
|
Overall Study
5-month Follow-up
|
113
|
139
|
|
Overall Study
COMPLETED
|
244
|
275
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
StriveWeekly Online Mental Health Trial Post-pandemic
Baseline characteristics by cohort
| Measure |
Immediate Intervention Condition
n=244 Participants
Participants in this condition will receive 7-8 weeks of online intervention modules. Specific modules will be selected based on a campus-wide needs assessment conducted in May 2021.
StriveWeekly: The intervention (app.striveweekly.com) delivers content via independent modules. Principles covered in content modules: Psychoeducation; Self-monitoring; Values-based goal-setting; Behavioral activation; Cognitive restructuring; Sleep hygiene; Time management; Interpersonal avoidance exposures; Physical exercise; Mindfulness; Relaxation strategies; Maintenance planning. Modules get released week-by-week, and participants are self-guided through content. To facilitate skills practice, every module is accompanied by: a weekly intro email and reminder emails; an "extras" section for tips/suggestions; and a weekly prize drawing. The "Dashboard" section of the intervention displays user progress, including self-rating graphs and a history log of skills practice. The "Campus" section of this dashboard provided: campus-specific announcements; referrals to relevant campus wellness resources; and an anonymous livestream of all campus users' activity.
|
Waitlist Condition
n=275 Participants
Participants in this condition will wait to receive StriveWeekly until after the Immediate Intervention condition is complete and participants from both conditions have completed the posttest survey.
|
Total
n=519 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Latinx · Prefer not to say
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
244 participants
n=5 Participants
|
275 participants
n=7 Participants
|
519 participants
n=5 Participants
|
|
LGBTQ+
Yes
|
58 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Age, Customized
16+
|
244 Participants
n=5 Participants
|
275 Participants
n=7 Participants
|
519 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female, Woman, Feminine, Trans Woman
|
157 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
332 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender-non-binary, -queer, -non-conforming, -fluid
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male, Man, Masculine, Trans Man
|
79 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Prefer Not to Say
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian or Asian American
|
64 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Middle Eastern
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · multiracial
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Native Hawaiian or other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
113 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Prefer Not to Say
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
LGBTQ+
Questioning or Unsure
|
14 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latinx · Yes
|
48 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
LGBTQ+
No
|
164 Participants
n=5 Participants
|
184 Participants
n=7 Participants
|
348 Participants
n=5 Participants
|
|
LGBTQ+
Prefer Not to Say
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latinx · No
|
191 Participants
n=5 Participants
|
227 Participants
n=7 Participants
|
418 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Posttest (~8 weeks)Change in self-reported symptoms of depression, anxiety, and stress (completed via online surveys). Items are rated on a scale of 0-3, with higher scores indicating worse symptoms. Subscale total scores range from 0-21, and DASS-21 total scores range from 0-63.
Outcome measures
| Measure |
Immediate Intervention Condition
n=244 Participants
Participants in this condition will receive 7-8 weeks of online intervention modules. Specific modules will be selected based on a campus-wide needs assessment conducted in May 2021.
StriveWeekly: The intervention (app.striveweekly.com) delivers content via independent modules. Principles covered in content modules: Psychoeducation; Self-monitoring; Values-based goal-setting; Behavioral activation; Cognitive restructuring; Sleep hygiene; Time management; Interpersonal avoidance exposures; Physical exercise; Mindfulness; Relaxation strategies; Maintenance planning. Modules get released week-by-week, and participants are self-guided through content. To facilitate skills practice, every module is accompanied by: a weekly intro email and reminder emails; an "extras" section for tips/suggestions; and a weekly prize drawing. The "Dashboard" section of the intervention displays user progress, including self-rating graphs and a history log of skills practice. The "Campus" section of this dashboard provided: campus-specific announcements; referrals to relevant campus wellness resources; and an anonymous livestream of all campus users' activity.
|
Waitlist Condition
n=275 Participants
Participants in this condition will wait to receive StriveWeekly until after the Immediate Intervention condition is complete and participants from both conditions have completed the posttest survey.
|
|---|---|---|
|
Depression Anxiety and Stress Scale (DASS-21)
baseline
|
16.9 score on a scale
Standard Deviation 10.14
|
16.3 score on a scale
Standard Deviation 10.13
|
|
Depression Anxiety and Stress Scale (DASS-21)
posttest
|
16.5 score on a scale
Standard Deviation 9.83
|
18.3 score on a scale
Standard Deviation 10.65
|
SECONDARY outcome
Timeframe: Baseline to Posttest (~8 weeks)10-item self-report about subjective experiences of stress (completed via online surveys). Items are rated on a scale of 0-4 (four items are reverse scored), with higher scores indicating worse stress. Total scores range from 0-40.
Outcome measures
| Measure |
Immediate Intervention Condition
n=244 Participants
Participants in this condition will receive 7-8 weeks of online intervention modules. Specific modules will be selected based on a campus-wide needs assessment conducted in May 2021.
StriveWeekly: The intervention (app.striveweekly.com) delivers content via independent modules. Principles covered in content modules: Psychoeducation; Self-monitoring; Values-based goal-setting; Behavioral activation; Cognitive restructuring; Sleep hygiene; Time management; Interpersonal avoidance exposures; Physical exercise; Mindfulness; Relaxation strategies; Maintenance planning. Modules get released week-by-week, and participants are self-guided through content. To facilitate skills practice, every module is accompanied by: a weekly intro email and reminder emails; an "extras" section for tips/suggestions; and a weekly prize drawing. The "Dashboard" section of the intervention displays user progress, including self-rating graphs and a history log of skills practice. The "Campus" section of this dashboard provided: campus-specific announcements; referrals to relevant campus wellness resources; and an anonymous livestream of all campus users' activity.
|
Waitlist Condition
n=275 Participants
Participants in this condition will wait to receive StriveWeekly until after the Immediate Intervention condition is complete and participants from both conditions have completed the posttest survey.
|
|---|---|---|
|
Perceived Stress Scale
Baseline
|
19.1 score on a scale
Standard Deviation 6.50
|
18.5 score on a scale
Standard Deviation 6.50
|
|
Perceived Stress Scale
Posttest
|
18.7 score on a scale
Standard Deviation 5.99
|
18.8 score on a scale
Standard Deviation 6.46
|
SECONDARY outcome
Timeframe: Baseline to Posttest (~8 weeks)A standardized 7-item scale designed to measure mental wellbeing in the general population (i.e., not necessarily clinical) and evaluate change in response to programs that aim to improve mental wellbeing. Completed via online surveys. Items are rated on a 5-point likert scale, with higher scores indicating a positive mental wellbeing and functioning. Total scores range from 7-35.
Outcome measures
| Measure |
Immediate Intervention Condition
n=244 Participants
Participants in this condition will receive 7-8 weeks of online intervention modules. Specific modules will be selected based on a campus-wide needs assessment conducted in May 2021.
StriveWeekly: The intervention (app.striveweekly.com) delivers content via independent modules. Principles covered in content modules: Psychoeducation; Self-monitoring; Values-based goal-setting; Behavioral activation; Cognitive restructuring; Sleep hygiene; Time management; Interpersonal avoidance exposures; Physical exercise; Mindfulness; Relaxation strategies; Maintenance planning. Modules get released week-by-week, and participants are self-guided through content. To facilitate skills practice, every module is accompanied by: a weekly intro email and reminder emails; an "extras" section for tips/suggestions; and a weekly prize drawing. The "Dashboard" section of the intervention displays user progress, including self-rating graphs and a history log of skills practice. The "Campus" section of this dashboard provided: campus-specific announcements; referrals to relevant campus wellness resources; and an anonymous livestream of all campus users' activity.
|
Waitlist Condition
n=275 Participants
Participants in this condition will wait to receive StriveWeekly until after the Immediate Intervention condition is complete and participants from both conditions have completed the posttest survey.
|
|---|---|---|
|
The Warwick-Edinburgh Mental Wellbeing Scales
Baseline
|
23.1 score on a scale
Standard Deviation 4.75
|
23.3 score on a scale
Standard Deviation 4.78
|
|
The Warwick-Edinburgh Mental Wellbeing Scales
Posttest
|
22.8 score on a scale
Standard Deviation 4.49
|
22.1 score on a scale
Standard Deviation 4.80
|
Adverse Events
Immediate Intervention Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Condition
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. Leslie Rith-Najarian, Principal Investigator
Strive Weekly Inc
Phone: 3108002143
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place