Ecological Momentary Assessment and Text Message Intervention for Stress Management (FACE Stress)

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

Study Overview

• Status: Completed
• Conditions: Covid19; Stress; Stress, Psychological; Loneliness
• Intervention / Treatment: Other: EMA + EMA and FACE Stress; Other: EMA Alone

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10013
      • Click Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1 week EMA followed by 2weeks of EMA and automated text messages of stress and coping; 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)	Other: 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; Other Names: Ecological Momentary Assessments (EMA) & FACE Stress
Other: 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.	Other: EMA Alone; Three weeks of EMA consisting of 2 daily surveys per day delivered during waking hours to evaluate ecological momentary affects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ecological Momentary Change in Affects	Changes in Momentary Affects will be measured by using Ecological Momentary Assessments delivered twice a day for 3 weeks.	3 Weeks
Changes in Perceived Stress	Changes in perceived stress will be measured by using the Perceived Stress Scale at Baseline, 3 weeks post-intervention, and at 1/3/6 month follow-up.	7 Months
Symptoms of Anxiety	Symptoms of Anxiety will be measured by using the Generalized Anxiety Disorder-7 item scale (GAD-7) at Baseline, 3 weeks post-intervention, and at 1/3/6 month follow-up.	7 Months
Symptoms of Depression	Change in depression will be measured by using the Patient Health Questionnaire (PHQ-9) at Baseline, 3 weeks post-intervention, and at 1/3/6 month follow-up.	7 Months
Symptoms of PTSD	Changes in PTSD will be measured by using the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) at Baseline, 3 weeks post-intervention, and at 1/3/6 month follow-up.	7 Months
Change in Resilience	Changes in resilience will be measured by using the Brief Resilience Scale (BRS) at Baseline, 3 weeks post-intervention, and at 1/3/6 month follow-up.	7 Months
Psychological Well-being	Changes in psychological well-being will be measured by using the Euthymia Scale at Baseline, 3 weeks post-intervention, and at 1/3/6 month follow-up.	7 Months
Loneliness	Changes in perceived loneliness will be measured by a single question (item) at Baseline, 3 weeks post-intervention, and at 1/3/6 month follow-up.	7 Months
Self-Mastery	Changes in self-mastery will be measured by using the Pearlin Self-Mastery Scale at Baseline, 3 weeks post-intervention, and at 1/3/6 month follow-up.	7 Months

Collaborators and Investigators

• Sponsor: Click Therapeutics, Inc.
• Investigators: Study Chair: Shaheen Lakhan, MDPhD, FAAN, Click Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2020
• Primary Completion (Actual): December 18, 2020
• Study Completion (Actual): June 20, 2021

Study Registration Dates

• First Submitted: April 2, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Anxiety; Stress; Ecological Momentary Assessment; Automated Text Message Intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: DL-FACE-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No