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

Sponsor
University of Zurich (Other)
Overall Status
Completed
CT.gov ID
NCT05617248
Collaborator
(none)
94
1
2
5.7
16.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Self-efficacy App
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
94 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomised controlled trial testing a brief digital intervention (SeApp) against a control group receiving only EMARandomised controlled trial testing a brief digital intervention (SeApp) against a control group receiving only EMA
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Assessors are blind to individuals' reports of perceived stress prior to and following the intervention, i.e. at all assessment times.
Primary Purpose:
Prevention
Official Title:
Feasibility and Efficacy of a Brief Digital Self-efficacy Training in University Students With Self-reported Elevated Stress: A Randomized Controlled Trial
Actual Study Start Date :
May 18, 2020
Actual Primary Completion Date :
Nov 9, 2020
Actual Study Completion Date :
Nov 9, 2020

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. General self-efficacy [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 Outcome Measures

  1. Perceived stress [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 [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 [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 [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 [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 [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 Outcome Measures

  1. Positive and negative affect [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 29 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Birgit Kleim Zurich Select... Switzerland 8008

Sponsors and Collaborators

  • University of Zurich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Zurich
ClinicalTrials.gov Identifier:
NCT05617248
Other Study ID Numbers:
  • SEAPPUZH
First Posted:
Nov 15, 2022
Last Update Posted:
Nov 15, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Zurich

Study Results

No Results Posted as of Nov 15, 2022