Trial Outcomes & Findings for Ecological Momentary Assessment and Text Message Intervention for Stress Management (NCT NCT04907942)
NCT ID: NCT04907942
Last Updated: 2025-05-08
Results Overview
The main outcome of the FACE STRESS study is to evaluate feasibility of an EMA and EMA plus text message intervention (EMA+), assessed by the number of completed individuals after the initial screening, from zero as worst to all subjects (best)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
3 weeks
Results posted on
2025-05-08
Participant Flow
Participant milestones
| Measure |
Arm 1:Active Intervention of 1 wk EMA + 2 Wks EMA Plus FACE Stress
1 wk of Ecological momentary Assessment (EMA), via text message and email followed by 2 additional wks of Ecological momentary Assessment (EMA) in combination with stress management techniques (FACE stress).
|
Arm 2: Control Using EMA Alone
Three weeks of Ecological Momentary Assessment (EMA) consisting of 2 daily surveys per day delivered during waking hours to evaluate ecological momentary affects.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
42
|
|
Overall Study
COMPLETED
|
39
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ecological Momentary Assessment and Text Message Intervention for Stress Management
Baseline characteristics by cohort
| Measure |
1) Active Intervention: 1 wk EMA Plus 2 Wks EMA and FACE Stress
n=39 Participants
1 wk EMA plus 2 weeks of EMA in combination with constructs from The Transactional Model of Stress and Coping (FACE Stress)
|
2) Control: EMA Alone
n=42 Participants
Three weeks of EMA consisting of 2 daily surveys per day during waking hours to evaluate momentary affects
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.1 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
33.5 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
35 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
42 participants
n=7 Participants
|
81 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: Feasibility assessed by the number of eligible individuals after the initial screening
The main outcome of the FACE STRESS study is to evaluate feasibility of an EMA and EMA plus text message intervention (EMA+), assessed by the number of completed individuals after the initial screening, from zero as worst to all subjects (best)
Outcome measures
| Measure |
1 Week EMA Followed by 2weeks of EMA and FACE Stress Technique
n=39 Participants
1 weeks of EMA (2 daily surveys per day waking hours to evaluate momentary affects) plus 2 weeks of EMA in combination of automated text messages delivered twice a day, which content follows constructs from The Transactional Model of Stress and Coping (FACE stress)
EMA + EMA and FACE Stress: 1 wk of EMA (2 daily surveys per day delivered during waking hours to evaluate momentary affects) plus 2 weeks of EMA and FACE stress
|
Control of EMA Alone
n=42 Participants
3 weeks of EMA, consisting of 2 surveys per day delivered via text message and email during waking hours to prompt participants to complete the survey.
EMA Alone: Three weeks of EMA consisting of 2 daily surveys per day delivered during waking hours to evaluate ecological momentary affects.
|
|---|---|---|
|
Number of Participants Who Completed EMA and EMA Plus Text Message Intervention or EMA Intervention Alone.
|
39 Participants
|
42 Participants
|
Adverse Events
Active Intervention; 3wks EMA and FACE Stress on Wks 2-3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 Wks EMA Alone
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
Shaheen Lakhan, MDPhD, FAAN Study Chair
Click Therapeutics
Phone: Not applicable
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place