Feasibility and Efficacy of a Brief Digital Self-efficacy Training (SEAPP)

Feasibility and Efficacy of a Brief Digital Self-efficacy Training in University Students With Self-reported Elevated Stress: A Randomized Controlled Trial

The study investigates the effects of a digital, scalable self-efficacy training of repeated recall of self-efficacy memories on mental health outcomes, such as self-efficacy, anxiety, stress, hopelessness, and other mental health outcomes. A total of 94 students with elevated stress levels (≤ 13 on the Perceived Stress Scale) will be recruited and randomly assigned to training and control group. Individuals will either engage in the self-efficacy training app combined with Ecological Momentary Assessment (EMA) for 1 week (training group) or in EMA only for 1 week (control group). Baseline and post assessments will measure changes in self-efficacy, anxiety, stress, hopelessness, and other mental health outcomes.

Study Overview

• Status: Completed
• Conditions: Stress; Self Efficacy
• Intervention / Treatment: Behavioral: Self-efficacy App

Detailed Description

Self-efficacy is associated with positive mental health outcomes and has been proposed as a putative contributor to therapeutic outcomes in the treatment of mental health problems. It can be enhanced through experimental inductions and the recall of autobiographical mastery experiences, which have mostly been conducted in person and in the laboratory until today.

The study will investigate effects of a digital, scalable self-efficacy training of repeated recall of self-efficacy memories on mental health outcomes, such as self-efficacy, anxiety, stress, hopelessness, and other mental health outcomes. The study will recruit 94 students with elevated stress levels (≤ 13 on the Perceived Stress Scale) and randomly assigned them to training and control group. Individuals will either engage in the self-efficacy training app combined with Ecological Momentary Assessment (EMA) for 1 week (training group) or in EMA only for 1 week (control group). Baseline and post assessments will measure changes in self-efficacy, anxiety, stress, hopelessness, and other mental health outcomes.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Select...
    • Zurich, Select..., Switzerland, 8008
      • Birgit Kleim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• being enrolled at a Swiss university
• aged between 18 and 29 years
• experiencing at least moderate stress (score of ≥13 on the Perceived Stress Scale
• owning a smartphone
• speaking fluent German

Exclusion Criteria:

-current psychiatric disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Self-efficacy training (App); This group will receive a digital one week self-efficacy training with three training sessions per day and EMA (10 per day).	Behavioral: Self-efficacy App; The training starts with a psychoeducational video and instructions to define two autobiographical self-efficacy The individuals will then receive three self-efficacy trainings per day based on their autobiographical memories and combined with a slow breathing exercise. Additionally, they will receive 10 daily EMA questionnaires on mood, social contacts, and virtual context.
No Intervention: Control; This group will receive EMA questionnaires for one week (10 per day).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General self-efficacy	The General Self-Efficacy Scale (Schwarzer & Jerusalem, 1995; Tipton & Worthington, 1984) will measure the general self-efficacy.	change from baseline to 1 day post intervention; time frame: 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived stress	The Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983; Klein et al., 2016) will measure perceived stress.	change from screening to 1 day post intervention; time frame: 1 week
Positive and negative affect	change from baseline to 1 day post intervention; time frame: 1 week	The Positive and Negative Affect Scale (Krohne, Egloff, Kohlmann, & Tausch, 1996; Watson, Clark, & Tellegen, 1988) will measure positive and negative affect.
Hope	The Trait Hope Scale (Krause, 2002; Snyder et al., 1991) will measure hope.	change from baseline to 1 day post intervention; time frame: 1 week
Depression	change from baseline to 1 day post intervention; time frame: 1 week	The Beck Depression Inventory-II (Beck, Steer, Ball, & Ranieri, 1996; Kuhner, Burger, Keller, & Hautzinger, 2007) will measure depression.
Anxiety	State-Trait Anxiety Inventory (Laux, Glanzmann, Schaffner, & Spielberger, 1981; Spielberger, Gorsuch, Lushene, Gagg, & Jacobs, 1983) will measure state and trait anxiety.	change from baseline to 1 day post intervention; time frame: 1 week
Hopelessness	The Beck Hopelessness Scale (Beck, Weissman, Lester, & Trexler, 1974; Kliem, Lohmann, Mossle, & Brahler, 2018) will measure hopelessness.	change from baseline to 1 day post intervention; time frame: 1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and negative affect	EMA will capture positive and negative mood at 10 time points per day during the one week study participation. We will measure positive mood using three items (cheerful, happy, and relaxed) and negative mood using seven items (irritated, anxious, insecure, lonely, sad, overthinking, and stressed).	Daily measured; changes in the course of the study participation
Dissatisfaction with social contacts	EMA will capture dissatisfaction with social contacts at 10 time points per day during the one week study participation. There will be two options indicating dissatisfaction with social contacts: (a) being with nobody and feeling excluded or wanting to be with someone or (b) being with someone and rather wanting to be alone. We combined these into one variable.	daily measured; changes in the course of the study participation
Specific self-efficacy	Specific self-efficacy will be captured once per day. Questions will focus on e. g. the participant's level of agreement with statements such as "Right now, I think I will be able to do what is necessary to make this training successful".	daily measured in training group only; changes in the course of the study participation
Virtual context	EMA will capture virtual context at 10 time points per day during the one week study participation. Questions will be about who the person is with and how they feel about it.	daily measured; changes in the course of the study participation

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2020
• Primary Completion (Actual): November 9, 2020
• Study Completion (Actual): November 9, 2020

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: November 13, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 13, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: self-efficacy, stress, digital, intervention
• Other Study ID Numbers: SEAPPUZH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: It is planned to make the anonymised data available on a public repository.

Drug and device information, study documents

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