Covid19, Loneliness, Stress, Stress, Psychological
Conditions
Keywords
Stress, Anxiety, Ecological Momentary Assessment, Automated Text Message Intervention
Brief summary
Feasibility and acceptability of an Ecological Momentary Assessment (EMA) compared with an EMA plus automated text message intervention for stress management
Detailed description
The purpose of this study is to evaluate feasibility and acceptability of an Ecological Momentary Assessment (EMA) compared with an EMA plus automated text message intervention for stress management in participants with higher-than-average perceived stress conducted in a remote setting. Study details include: Study Duration: 7 months Intervention Duration: 3 weeks
Interventions
OTHEREMA + 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
OTHEREMA Alone
Three weeks of EMA consisting of 2 daily surveys per day delivered during waking hours to evaluate ecological momentary affects.
Sponsors
Click Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age 22 years or older 2. Must reside in an Eastern Standard Time or Central Standard Time zone 3. Able to read and write in English as demonstrated by review and completion of an Informed Consent Form 4. Own an SMS enabled smartphone 5. Scoring \>5 on the 4-item Perceived Stress Scale (reflecting higher-than-average perceived stress)
Exclusion criteria
1. Reported cognitive impairment and/or psychiatric disorders of the psychotic spectrum 2. Enrolled in another support study 3. Currently receiving psychotherapy through telehealth 4. PHQ-9 score of 20 or greater.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Completed EMA and EMA Plus Text Message Intervention or EMA Intervention Alone. | 3 weeks | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1) Active Intervention: 1 wk EMA Plus 2 Wks EMA and FACE Stress 1 wk EMA plus 2 weeks of EMA in combination with constructs from The Transactional Model of Stress and Coping (FACE Stress) | 39 |
| 2) Control: EMA Alone Three weeks of EMA consisting of 2 daily surveys per day during waking hours to evaluate momentary affects | 42 |
| Total | 81 |
Baseline characteristics
| Characteristic | 1) Active Intervention: 1 wk EMA Plus 2 Wks EMA and FACE Stress | Total | 2) Control: EMA Alone |
|---|---|---|---|
| Age, Continuous | 36.1 years STANDARD_DEVIATION 11.2 | 35 years STANDARD_DEVIATION 12 | 33.5 years STANDARD_DEVIATION 12.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 8 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 23 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) White | 19 Participants | 43 Participants | 24 Participants |
| Region of Enrollment United States | 39 participants | 81 participants | 42 participants |
| Sex: Female, Male Female | 24 Participants | 50 Participants | 26 Participants |
| Sex: Female, Male Male | 15 Participants | 31 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 42 |
| other Total, other adverse events | 0 / 39 | 0 / 42 |
| serious Total, serious adverse events | 0 / 39 | 0 / 42 |
Outcome results
Primary
Number of Participants Who Completed EMA and EMA Plus Text Message Intervention or EMA Intervention Alone.
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)
Time frame: 3 weeks
Population: Feasibility assessed by the number of eligible individuals after the initial screening
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1 Week EMA Followed by 2weeks of EMA and FACE Stress Technique | Number of Participants Who Completed EMA and EMA Plus Text Message Intervention or EMA Intervention Alone. | 39 Participants |
| Control of EMA Alone | Number of Participants Who Completed EMA and EMA Plus Text Message Intervention or EMA Intervention Alone. | 42 Participants |