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

Sponsor
Click Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04907942
Collaborator
(none)
82
Enrollment
1
Location
2
Arms
7.7
Actual Duration (Months)
10.7
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: EMA + Automated Text Message Intervention
  • Behavioral: EMA Alone
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Feasibility and Acceptability of Click's Ecological Momentary Assessment (EMA) and Text Message Intervention for STRESS Management (FACE STRESS Study)
Actual Study Start Date :
Oct 29, 2020
Actual Primary Completion Date :
Dec 18, 2020
Actual Study Completion Date :
Jun 20, 2021

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 as the proportion of individuals who contacted us because they are interested in participating

    2. 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 eligible individuals after the initial screening

    3. 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 time taken to recruit the sample

    4. 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 calculating the retention rates

    5. 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

    6. 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 (satisfaction/utility) by using open-ended questions/patient interviews

    7. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. 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.

    8. 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.

    9. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Click Therapeutics New York New York United States 10013

    Sponsors and Collaborators

    • Click Therapeutics, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Click Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT04907942
    Other Study ID Numbers:
    • DL-FACE-101
    First Posted:
    Jun 1, 2021
    Last Update Posted:
    Jul 27, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Click Therapeutics, Inc.
    Stress
    Anxiety
    Ecological Momentary Assessment
    Automated Text Message Intervention
    Additional relevant MeSH terms:
    Stress, Psychological

    Study Results

    No Results Posted as of Jul 27, 2021