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

• Sponsor: The New School (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06140498
• Collaborator: University of Zurich (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 25
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Self Efficacy	Behavioral: Self-Efficacy Training and Ecological Momentary Assessment; Behavioral: Control intervention: Ecological Momentary Assessment only	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Random Allocation, 2 Arms allocation to groups blinded, parallel assignment, masking participant, outcome assessor, investigator.Random Allocation, 2 Arms allocation to groups blinded, parallel assignment, masking participant, outcome assessor, investigator.
• Masking: Single (Investigator)
• Masking Description: Parallel Assignment
• Primary Purpose: Treatment
• Official Title: Feasibility of a Self-Efficacy Ecological Momentary Intervention (EMA) App
• Actual Study Start Date: Nov 1, 2021
• Actual Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. General Self-Efficacy [after app completion and 1 month after app completion]

   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)

Secondary Outcome Measures

1. Perceived Stress [after app completion and 1 month after app completion]

   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)

2. Intolerance of Uncertainty [after app completion and 1 month after app completion]

   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)

3. State and Trait Anxiety [after app completion and 1 month after app completion]

   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)

4. Positive and Negative Affect positive and negative affect [after app completion and 1 month after app completion]

   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)

5. Hopelessness [after app completion and 1 month after app completion]

   change in hopelessness measured using the BHS

6. Depression [after app completion and 1 month after app completion]

   change in depression measured using the Beck Hopelessness Scale (BDI-II; 20 true and false items with higher scores indicating greater levels of hopelessness)

Other Outcome Measures

1. Ecological Momentary Assessment [through app participation (1 week)]

   change of momentary mood

2. Hope [after app completion and 1 month after app completion]

   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)

3. Satisfaction with Mobile Application [single time point: immediately after the intervention]

   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)

4. Coronavirus Anxiety Scale [after app completion and 1 month after app completion]

   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)

5. Self-efficacy memories [single time point: baseline]

   exploratory (descriptive) analysis, using no scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 61 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Value on Perceived Stress Scale ≥ 13

2. Student

3. Owner of a smartphone

Exclusion Criteria:

1. Psychiatric history

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The New School	New York	New York	United States	10011

Sponsors and Collaborators

• The New School
• University of Zurich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adam Brown, Ph.D., Associate Professor of Psychology (Clinical) and Vice Provost for Research, The New School
• ClinicalTrials.gov Identifier: NCT06140498
• Other Study ID Numbers: 2020-96
• First Posted: Nov 20, 2023
• Last Update Posted: Nov 20, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 20, 2023