Feasibility of a Self-Efficacy Ecological Momentary Intervention (EMA) App

Self Efficacy Clinical Trial

— EMA  

Official title:

Feasibility of a Self-Efficacy Ecological Momentary Intervention (EMA) App

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06140498
• Other study ID #: 2020-96
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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 -

Related Conditions & MeSH terms

• Self Efficacy

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