Stress, PsychologicalNCT04907942
Ecological Momentary Assessment and Text Message Intervention for Stress Management
A study testing EMA + EMA and FACE Stress and EMA Alone in people with Stress, Psychological and Loneliness, run by Click Therapeutics, Inc. at 1 site in United States.
Trial summary
Feasibility and acceptability of an Ecological Momentary Assessment (EMA) compared with an EMA plus automated text message intervention for stress management Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Loneliness, Covid19
- What is being tested?
- EMA + EMA and FACE Stress and EMA Alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2020to 20 Jun 2021
- Phase
- Interventional
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 22 years or older
- Must reside in an Eastern Standard Time or Central Standard Time zone
- Able to read and write in English as demonstrated by review and completion of an Informed Consent Form
- Own an SMS enabled smartphone
- Scoring >5 on the 4-item Perceived Stress Scale (reflecting higher-than-average perceived stress)
Who cannot join
- Reported cognitive impairment and/or psychiatric disorders of the psychotic spectrum
- Enrolled in another support study
- Currently receiving psychotherapy through telehealth
- PHQ-9 score of 20 or greater.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Click's Ecological Momentary Assessment (EMA) and Text Message Intervention for Stress Management (FACE STRESS Study)
Feasibility and acceptability of an Ecological Momentary Assessment (EMA) compared with an EMA plus automated text message intervention for stress management
Read the 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
- Conditions
- Stress, Psychological, Loneliness, Covid19, Stress
- Being tested
- EMA + EMA and FACE Stress, EMA Alone
- Keywords
- Stress, Anxiety, Ecological Momentary Assessment, Automated Text Message Intervention
- Medical subject headings
- Stress, Psychological, COVID-19, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMA + EMA and FACE StressOther
Also called Ecological Momentary Assessments (EMA) & 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
EMA AloneOther
Three weeks of EMA consisting of 2 daily surveys per day delivered during waking hours to evaluate ecological momentary affects.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: EMA + EMA and 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. Receives: Other: EMA Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start29 Oct 2020
- Primary completion18 Dec 2020
- Study completion20 Jun 2021
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 Stress, PsychologicalStudies 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Click Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shaheen Lakhan, MDPhD, FAAN, Study chair, Click Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907942
- Sponsor's protocol ID
- DL-FACE-101
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2021
- Last updated
- 8 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Click's Ecological Momentary Assessment (EMA) and Text Message Intervention for Stress Management (FACE STRESS Study)
- ClinicalTrials.gov ID
- NCT04907942
- Acronym / sponsor ID
- DL-FACE-101
- Conditions
- Stress, Psychological, Loneliness, Covid19, Stress
- Keywords
- Stress, Anxiety, Ecological Momentary Assessment, Automated Text Message Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Click Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Posted 8 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 week EMA followed by 2weeks of EMA and automated text messages of stress and coping | Active comparator | Other: EMA + EMA and FACE Stress1 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 | Other: EMA Alone3 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 22 years or older
- Must reside in an Eastern Standard Time or Central Standard Time zone
- Able to read and write in English as demonstrated by review and completion of an Informed Consent Form
- Own an SMS enabled smartphone
- Scoring >5 on the 4-item Perceived Stress Scale (reflecting higher-than-average perceived stress)
Key exclusion criteria (4 listed)
- Reported cognitive impairment and/or psychiatric disorders of the psychotic spectrum
- Enrolled in another support study
- Currently receiving psychotherapy through telehealth
- PHQ-9 score of 20 or greater.
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 |
|---|---|---|
| EMA + EMA and FACE StressAlso: Ecological Momentary Assessments (EMA) & FACE Stress1 wk of EMA (2 daily surveys per day delivered during waking hours to evaluate momentary affects) plus 2 weeks of EMA and FACE stress | Other | 1 week EMA followed by 2weeks of EMA and automated text messages of stress and coping |
| EMA AloneThree weeks of EMA consisting of 2 daily surveys per day delivered during waking hours to evaluate ecological momentary affects. | Other | Control of EMA alone |
Primary outcome
Number of Participants Who Completed EMA and EMA Plus Text Message Intervention or EMA Intervention Alone.
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Shaheen Lakhan, MDPhD, FAAN study chair
Click Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMA + EMA and FACE Stress and EMA Alone in people with Stress, Psychological and Loneliness, run by Click Therapeutics, 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 8 May 2025. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2025). 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?
Number of Participants Who Completed EMA and EMA Plus Text Message Intervention or EMA Intervention Alone. (time frame: 3 weeks). 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 8 May 2025.