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Feasibility and acceptability of an Ecological Momentary Assessment (EMA) compared with an EMA plus automated text message intervention for stress management
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 week EMA followed by 2weeks of EMA and automated text messages of stress and coping | Active Comparator | 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) |
|
| Control of EMA alone | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMA + EMA and FACE Stress | Other | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaheen Lakhan, MDPhD, FAAN | Click Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Click Therapeutics | New York | New York | 10013 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | 2) Control: EMA Alone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Feasibility assessed by the number of eligible individuals after the initial screening | Posted | Count of Participants | Participants | 3 weeks |
|
3 weeks (Intervention period)
pilot study with text messages and no study drugs administration
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Intervention; 3wks EMA and FACE Stress on Wks 2-3 | 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shaheen Lakhan, MDPhD, FAAN Study Chair | Click Therapeutics | Not applicable | Science@clicktherapeutics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2020 | Apr 24, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D000086382 | COVID-19 |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
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| ID | Term |
|---|---|
| D000072860 | Ecological Momentary Assessment |
| ID | Term |
|---|---|
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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|
| EMA Alone | Other | Three weeks of EMA consisting of 2 daily surveys per day delivered during waking hours to evaluate ecological momentary affects. |
|
Three weeks of EMA consisting of 2 daily surveys per day during waking hours to evaluate momentary affects
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control of EMA Alone | 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. |
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | 3 Wks EMA Alone | Three weeks of EMA consisting of 2 daily surveys per day during waking hours to evaluate momentary affects. | 0 | 42 | 0 | 42 | 0 | 42 |
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| D012141 |
| Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001523 | Mental Disorders |