Feasibility and Efficacy of a Brief Digital Self-efficacy Training

Stress Clinical Trial

— SEAPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05617248
• Other study ID #: SEAPPUZH
• Status: Completed
• Phase: N/A
• Start date: May 18, 2020
• Est. completion date: November 9, 2020

Study information

• Verified date: November 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: November 9, 2020
• Est. primary completion date: November 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Self Efficacy
• Stress

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Birgit Kleim	Zurich	Select...

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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
Secondary	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