Ecological Momentary Assessment and Text Message Intervention for Stress Management

NCT04907942 | Completed Results

• 1 other identifier: DL-FACE-101
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Feasibility and acceptability of an Ecological Momentary Assessment (EMA) compared with an EMA plus automated text message intervention for stress management

Conditions

Stress, Psychological; Loneliness; Covid19; Stress

Keywords

Stress; Anxiety; Ecological Momentary Assessment; Automated Text Message Intervention

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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)

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.

Other: EMA Alone

Interventions

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

Also known as: Ecological Momentary Assessments (EMA) & FACE Stress

1 week EMA followed by 2weeks of EMA and automated text messages of stress and coping

EMA Alone OTHER

Three weeks of EMA consisting of 2 daily surveys per day delivered during waking hours to evaluate ecological momentary affects.

Control of EMA alone

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Click Therapeutics, Inc.: lead

Study Sites (1)

Click Therapeutics

New York, New York, 10013, United States

Location

MeSH Terms

Conditions

Stress, Psychological; COVID-19; Anxiety Disorders

Interventions

Ecological Momentary Assessment

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Shaheen Lakhan, MDPhD, FAAN Study Chair
• Organization: Click Therapeutics

Science@clicktherapeutics.com

Not applicable

Study Officials

• Shaheen Lakhan, MDPhD, FAAN

  Click Therapeutics

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: June 1, 2021
• Study Start: October 29, 2020
• Primary Completion: December 18, 2020
• Study Completion: June 20, 2021
• Last Updated: May 8, 2025
• Results First Posted: May 8, 2025

Record last verified: 2025-04

Locations

US (1)