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

Phase 1

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

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

Detailed Description

Not available

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
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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)

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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.

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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
The main outcome of the FACE STRESS study is to evaluate feasibility of an EMA and EMA plus text message intervention (EMA+).	1 Month	Feasibility assessed by the number of participants responding to any EMA text over the 3-week study
The main outcome of the FACE STRESS study is to evaluate acceptability of an EMA and EMA plus text message intervention (EMA+).	1 Month	Acceptability assessed by Likert-scales

Secondary Outcome Measures

Name	Time	Method
Ecological Momentary Change in Affects	3 Weeks	Changes in Momentary Affects will be measured by using Ecological Momentary Assessments delivered twice a day for 3 weeks.
Symptoms of Anxiety	7 Months	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.
Symptoms of Depression	7 Months	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.
Changes in Perceived Stress	7 Months	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.
Loneliness	7 Months	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.
Symptoms of PTSD	7 Months	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.
Change in Resilience	7 Months	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.
Psychological Well-being	7 Months	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.
Self-Mastery	7 Months	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.

Trial Locations

Locations (1)

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