CD2H COVID-19

Feasibility and Acceptability of Click's EMA and Text Message Intervention for STRESS Management

Purpose

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

Eligibility

Eligible Ages: Over 22 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

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

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

Phase: Phase 1/Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Other
Masking: Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator 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.	Behavioral: EMA Alone Three weeks of EMA consisting of 2 daily surveys per day delivered during waking hours to evaluate momentary affects.
Experimental 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.	Device: EMA + Automated Text Message Intervention Intervention includes 3 weeks of EMA (2 daily surveys per day delivered during waking hours to evaluate momentary affects) plus 2 weeks of automated text messages delivered twice a day, which content follows constructs from The Transactional Model of Stress and Coping. Other names: Ecological Momentary Assessments

Recruiting Locations

More Details

NCT ID: NCT04907942
Status: Completed
Sponsor: Click Therapeutics, Inc.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.