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

Covid19 Clinical Trial

— FACE Stress  

Official title:

Feasibility and Acceptability of Click's Ecological Momentary Assessment (EMA) and Text Message Intervention for STRESS Management (FACE STRESS Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04907942
• Other study ID #: DL-FACE-101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 29, 2020
• Est. completion date: June 20, 2021

Study information

• Verified date: July 2021
• Source: Click Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 20, 2021
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Loneliness
• Stress
• Stress, Psychological

Intervention

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.

Behavioral:
• EMA Alone
Three weeks of EMA consisting of 2 daily surveys per day delivered during waking hours to evaluate momentary affects.

Locations

Country	Name	City	State
United States	Click Therapeutics	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Click Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main outcome of the FACE STRESS study is to evaluate feasibility of an EMA and EMA plus text message intervention (EMA+).	Feasibility assessed as the proportion of individuals who contacted us because they are interested in participating	1 Month
Primary	The main outcome of the FACE STRESS study is to evaluate feasibility of an EMA and EMA plus text message intervention (EMA+).	Feasibility assessed by the number of eligible individuals after the initial screening	1 Month
Primary	The main outcome of the FACE STRESS study is to evaluate feasibility of an EMA and EMA plus text message intervention (EMA+).	Feasibility assessed by the time taken to recruit the sample	1 Month
Primary	The main outcome of the FACE STRESS study is to evaluate feasibility of an EMA and EMA plus text message intervention (EMA+).	Feasibility assessed by calculating the retention rates	1 Month
Primary	The main outcome of the FACE STRESS study is to evaluate feasibility of an EMA and EMA plus text message intervention (EMA+).	Feasibility assessed by the number of participants responding to any EMA text over the 3-week study	1 Month
Primary	The main outcome of the FACE STRESS study is to evaluate acceptability of an EMA and EMA plus text message intervention (EMA+).	Acceptability (satisfaction/utility) by using open-ended questions/patient interviews	1 Month
Primary	The main outcome of the FACE STRESS study is to evaluate acceptability of an EMA and EMA plus text message intervention (EMA+).	Acceptability assessed by Likert-scales	1 Month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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