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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Self Efficacy

Intervention / Treatment
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* Behavioral: Self-Efficacy Training and Ecological Momentary Assessment
* Behavioral: Control intervention: Ecological Momentary Assessment only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Value on Perceived Stress Scale ≥ 13 Student Owner of a smartphone Exclusion Criteria: 1. Psychiatric history -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 61 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Random Allocation, 2 Arms allocation to groups blinded, parallel assignment, masking participant, outcome assessor, investigator.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |