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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04907942
Other study ID # DL-FACE-101
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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