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

  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

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

ArmDescriptionAssigned 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.