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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Self Efficacy
• Intervention / Treatment: Behavioral: Self-Efficacy Training and Ecological Momentary Assessment; Behavioral: Control intervention: Ecological Momentary Assessment only

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10011
      • The New School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Value on Perceived Stress Scale ≥ 13
2. Student
3. Owner of a smartphone

Exclusion Criteria:

1. Psychiatric history

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Digital Self-Efficacy Training with 3 trainings daily and Ecological Momentary Assessment	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
Active Comparator: Control; Ecological Momentary Assessment	Behavioral: Control intervention: Ecological Momentary Assessment only; Participants receive Ecological Momentary Assessments assessing mood, social contacts, and virtual context 3x/day for one week only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Hopelessness	change in hopelessness measured using the BHS	after app completion and 1 month after app completion
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ecological Momentary Assessment	change of momentary mood	through app participation (1 week)
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
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
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
Self-efficacy memories	exploratory (descriptive) analysis, using no scale	single time point: baseline

Collaborators and Investigators

• Sponsor: The New School
• Collaborators: University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): December 1, 2022
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 20, 2023

Study Record Updates

• Last Update Posted (Actual): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2020-96

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No