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Feasibility and Acceptability of Click's EMA and Text Message Intervention for STRESS Management (FACE Stress)

Primary Purpose

Stress, Psychological, Loneliness, Covid19

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EMA + Automated Text Message Intervention
EMA Alone
Sponsored by
Click Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stress, Psychological focused on measuring Stress, Anxiety, Ecological Momentary Assessment, Automated Text Message Intervention

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Click Therapeutics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

EMA Alone

EMA + Automated Text Message Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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

Secondary Outcome Measures

Ecological Momentary Change in Affects
Changes in Momentary Affects will be measured by using Ecological Momentary Assessments delivered twice a day for 3 weeks.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 2, 2021
Last Updated
July 26, 2021
Sponsor
Click Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04907942
Brief Title
Feasibility and Acceptability of Click's EMA and Text Message Intervention for STRESS Management
Acronym
FACE Stress
Official Title
Feasibility and Acceptability of Click's Ecological Momentary Assessment (EMA) and Text Message Intervention for STRESS Management (FACE STRESS Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 29, 2020 (Actual)
Primary Completion Date
December 18, 2020 (Actual)
Study Completion Date
June 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Click Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Loneliness, Covid19, Stress
Keywords
Stress, Anxiety, Ecological Momentary Assessment, Automated Text Message Intervention

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMA Alone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
EMA + Automated Text Message Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
EMA + Automated Text Message Intervention
Other Intervention Name(s)
Ecological Momentary Assessments
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
EMA Alone
Intervention Description
Three weeks of EMA consisting of 2 daily surveys per day delivered during waking hours to evaluate momentary affects.
Primary Outcome Measure Information:
Title
The main outcome of the FACE STRESS study is to evaluate feasibility of an EMA and EMA plus text message intervention (EMA+).
Description
Feasibility assessed as the proportion of individuals who contacted us because they are interested in participating
Time Frame
1 Month
Title
The main outcome of the FACE STRESS study is to evaluate feasibility of an EMA and EMA plus text message intervention (EMA+).
Description
Feasibility assessed by the number of eligible individuals after the initial screening
Time Frame
1 Month
Title
The main outcome of the FACE STRESS study is to evaluate feasibility of an EMA and EMA plus text message intervention (EMA+).
Description
Feasibility assessed by the time taken to recruit the sample
Time Frame
1 Month
Title
The main outcome of the FACE STRESS study is to evaluate feasibility of an EMA and EMA plus text message intervention (EMA+).
Description
Feasibility assessed by calculating the retention rates
Time Frame
1 Month
Title
The main outcome of the FACE STRESS study is to evaluate feasibility of an EMA and EMA plus text message intervention (EMA+).
Description
Feasibility assessed by the number of participants responding to any EMA text over the 3-week study
Time Frame
1 Month
Title
The main outcome of the FACE STRESS study is to evaluate acceptability of an EMA and EMA plus text message intervention (EMA+).
Description
Acceptability (satisfaction/utility) by using open-ended questions/patient interviews
Time Frame
1 Month
Title
The main outcome of the FACE STRESS study is to evaluate acceptability of an EMA and EMA plus text message intervention (EMA+).
Description
Acceptability assessed by Likert-scales
Time Frame
1 Month
Secondary Outcome Measure Information:
Title
Ecological Momentary Change in Affects
Description
Changes in Momentary Affects will be measured by using Ecological Momentary Assessments delivered twice a day for 3 weeks.
Time Frame
3 Weeks
Title
Changes in Perceived Stress
Description
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.
Time Frame
7 Months
Title
Symptoms of Anxiety
Description
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.
Time Frame
7 Months
Title
Symptoms of Depression
Description
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.
Time Frame
7 Months
Title
Symptoms of PTSD
Description
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.
Time Frame
7 Months
Title
Change in Resilience
Description
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.
Time Frame
7 Months
Title
Psychological Well-being
Description
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.
Time Frame
7 Months
Title
Loneliness
Description
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.
Time Frame
7 Months
Title
Self-Mastery
Description
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.
Time Frame
7 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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.
Facility Information:
Facility Name
Click Therapeutics
City
New York
State/Province
New York
ZIP/Postal Code
10013
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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