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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06140498
Other study ID # 2020-96
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date December 1, 2023

Study information

Verified date November 2023
Source The New School
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This "SeApp" study aims to test a self-efficacy Ecological Momentary Intervention (EMI) in healthy students in the context of COVID-19. EMIs are mostly smartphone-based applications that deliver interventions to people while being engaged in their daily life activities. The app harnesses the power of self-efficacy autobiographical memories (e.g. problem-solving memories, memories of success). Ecological Momentary Assessments (EMAs) are also incorporated into the study to capture individuals' feelings, affect, and behavior in real time.


Description:

This "SeApp" study aims to test a self-efficacy Ecological Momentary Intervention (EMI) in healthy students in the context of COVID-19. EMIs are mostly smartphone-based applications that deliver interventions to people while being engaged in their daily life activities. The app harnesses the power of self-efficacy autobiographical memories (e.g. problem-solving memories, memories of success). Ecological Momentary Assessments (EMAs) are also incorporated into the study to capture individuals' feelings, affect, and behavior in real time. Developed by psychologist Dr. Albert Bandura in 1977, the concept of self-efficacy refers to an individual's belief in their ability to perform the necessary actions to manage particular situations. Bandura's theory highlights four major components of self-efficacy, including mastery experiences, socialmodeling, social persuasion, and psychological responses. The app tested here focuses on mastery experiences, which are what individuals gain when they take on a challenge and succeed. The app prompts participants in the daily recall of self-efficacy memories. The project aims to test its feasibility and to investigate how daily self-efficacy and motivation can be enhanced and perceived stress reduced by daily memory-based training via smartphone app.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date December 1, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 61 Years
Eligibility Inclusion Criteria: 1. Value on Perceived Stress Scale = 13 2. Student 3. Owner of a smartphone Exclusion Criteria: 1. Psychiatric history -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Self-Efficacy Training and Ecological Momentary Assessment
Participants receive 3 self-efficacy trainings per day, combined with Ecological Momentary Assessments assessing mood, social contacts, and virtual context 3x/day for one week
Control intervention: Ecological Momentary Assessment only
Participants receive Ecological Momentary Assessments assessing mood, social contacts, and virtual context 3x/day for one week only

Locations

Country Name City State
United States The New School New York New York

Sponsors (2)

Lead Sponsor Collaborator
The New School University of Zurich

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Ecological Momentary Assessment change of momentary mood through app participation (1 week)
Other Hope change in hope measured using the Adult Hope Scale (AHS; consists of 12 items, and respondents are required to rate each item on an 8-point Likert scale; min=12, max=96) after app completion and 1 month after app completion
Other Satisfaction with Mobile Application to evaluate usage of app using the User version of the Mobile Application Rating Scale (uMARS; consists of 20 itesm, scores ranges from 1 to 5; the total score could range from 20 to 100, with higher scores indicating a higher overall quality rating for the app) single time point: immediately after the intervention
Other Coronavirus Anxiety Scale to evaluate association with coronoavirus anxiety the coronavirus anxiety scale is used (10 items, each rated on a scale of 0 to 4, the total score could range from 0 to 40) after app completion and 1 month after app completion
Other Self-efficacy memories exploratory (descriptive) analysis, using no scale single time point: baseline
Primary General Self-Efficacy change in general self-efficacy meeasured using the General Self-Efficacy Scale (GSE, 10 items rated on a 4-point Likert scale with higher scores indicating greater levels of self-efficacy; min=10, max=40) after app completion and 1 month after app completion
Secondary Perceived Stress change in perceived stress measured using the Perceived Stress Scale (PSS; 10 items rated on a 0-4 scale with higher scores indicating greater levels of perceived stress; min=0, max=40) after app completion and 1 month after app completion
Secondary Intolerance of Uncertainty change in intolerance of uncertainty measured using the Intolerance of Uncertainty Scale (IUS; 12 items rated on a 5-point Likert scale with higher scores indicating greater intolerance of uncertainty; min=12, max=60) after app completion and 1 month after app completion
Secondary State and Trait Anxiety change in state and trait anxiety measured using the The State-Trait Anxiety Inventory (STAI; 40 items rated on a 4-point Likert scale with a commonly used cutoff score of 40 indicating probable clinical levels of anxiety; min=20, max=80 on the subscales) after app completion and 1 month after app completion
Secondary Positive and Negative Affect positive and negative affect change in positive and negative affect measured using the Positive and Negative Affect Scale (PANAS; 20 items rated on a 5-point Likert scale with 10 items measuring positive affect and 10 items measuring and higher scores indicating greater levels of positive or negative affect; min=10, max=50 on the subscales) after app completion and 1 month after app completion
Secondary Hopelessness change in hopelessness measured using the BHS after app completion and 1 month after app completion
Secondary Depression change in depression measured using the Beck Hopelessness Scale (BDI-II; 20 true and false items with higher scores indicating greater levels of hopelessness) after app completion and 1 month after app completion
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