Ecological Momentary Assessment and Text Message Intervention for Stress Management

Not Applicable

Completed

• Conditions: Loneliness; Covid19; Stress; Stress, Psychological
• Interventions: Device: EMA + Automated Text Message Intervention; Behavioral: EMA Alone

• Registration Number: NCT04907942
• Lead Sponsor: Click Therapeutics, Inc.

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

Study Timeline

• Study Start: 2020-10-29
• Primary Completion: 2020-12-18
• Study First Submitted: 2021-04-02
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-06-01
• Study Completion: 2021-06-20
• Results First Submitted: 2022-06-27
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Results First Posted: 2025-05-08
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMA + Automated Text Message Intervention	EMA + Automated Text Message Intervention	* 1 week of EMA, consisting of 2 surveys per day delivered via text message and email during waking hours to prompt participants to complete the survey followed by * 2 additional weeks of EMA in combination with 2 text messages per day with content related to stress management techniques.
EMA Alone	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.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Click Therapeutics; 🇺🇸 New York, New York, United States