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Completed

NCT Number: NCT05617248

Feasibility and Efficacy of a Brief Digital Self-efficacy Training

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.

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Key information

Conditions

Stress Self Efficacy

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Birgit Kleim

Zurich, Select..., 8008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-efficacy App

Behavioral

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.

Primary outcomes

  1. General self-efficacy

    Time frame: change from baseline to 1 day post intervention; time frame: 1 week

    The General Self-Efficacy Scale (Schwarzer & Jerusalem, 1995; Tipton & Worthington, 1984) will measure the general self-efficacy.

Secondary outcomes

  1. Perceived stress

    Time frame: change from screening to 1 day post intervention; time frame: 1 week

    The Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983; Klein et al., 2016) will measure perceived stress.

  2. Positive and negative affect

    Time frame: The Positive and Negative Affect Scale (Krohne, Egloff, Kohlmann, & Tausch, 1996; Watson, Clark, & Tellegen, 1988) will measure positive and negative affect.

    change from baseline to 1 day post intervention; time frame: 1 week

  3. Hope

    Time frame: change from baseline to 1 day post intervention; time frame: 1 week

    The Trait Hope Scale (Krause, 2002; Snyder et al., 1991) will measure hope.

  4. Depression

    Time frame: The Beck Depression Inventory-II (Beck, Steer, Ball, & Ranieri, 1996; Kuhner, Burger, Keller, & Hautzinger, 2007) will measure depression.

    change from baseline to 1 day post intervention; time frame: 1 week

  5. Anxiety

    Time frame: change from baseline to 1 day post intervention; time frame: 1 week

    State-Trait Anxiety Inventory (Laux, Glanzmann, Schaffner, & Spielberger, 1981; Spielberger, Gorsuch, Lushene, Gagg, & Jacobs, 1983) will measure state and trait anxiety.

  6. Hopelessness

    Time frame: change from baseline to 1 day post intervention; time frame: 1 week

    The Beck Hopelessness Scale (Beck, Weissman, Lester, & Trexler, 1974; Kliem, Lohmann, Mossle, & Brahler, 2018) will measure hopelessness.

Other outcomes

  1. Positive and negative affect

    Time frame: Daily measured; changes in the course of the study participation

    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).

  2. Dissatisfaction with social contacts

    Time frame: daily measured; changes in the course of the study participation

    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.

  3. Specific self-efficacy

    Time frame: daily measured in training group only; changes in the course of the study participation

    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".

  4. Virtual context

    Time frame: daily measured; changes in the course of the study participation

    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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: SEAPP

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 15, 2022
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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