NCT05617248

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

September 12, 2022

Last Update Submit

November 13, 2022

Conditions

Keywords

self-efficacy, stress, digital, intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Perceived stress

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

  • 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.

  • Hope

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

  • Depression

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

  • Anxiety

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

  • +1 more secondary outcomes

Other Outcomes (4)

  • Positive and negative affect

    Daily measured; changes in the course of the study participation

  • Dissatisfaction with social contacts

    daily measured; changes in the course of the study participation

  • Specific self-efficacy

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

  • +1 more other outcomes

Study Arms (2)

Experimental: Self-efficacy training (App)

EXPERIMENTAL

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

Control

NO INTERVENTION

This group will receive EMA questionnaires for one week (10 per day).

Interventions

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.

Experimental: Self-efficacy training (App)

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • current psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Birgit Kleim

Zurich, Select..., 8008, Switzerland

Location

Related Publications (2)

  • Rohde J, Marciniak MA, Henninger M, Homan S, Ries A, Paersch C, Friedman O, Brown AD, Kleim B. Effects of a digital self-efficacy training in stressed university students: A randomized controlled trial. PLoS One. 2024 Oct 31;19(10):e0305103. doi: 10.1371/journal.pone.0305103. eCollection 2024.

  • Rohde J, Marciniak MA, Henninger M, Homan S, Paersch C, Egger ST, Seifritz E, Brown AD, Kleim B. Investigating Relationships Among Self-Efficacy, Mood, and Anxiety Using Digital Technologies: Randomized Controlled Trial. JMIR Form Res. 2023 Aug 14;7:e45749. doi: 10.2196/45749.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Assessors are blind to individuals' reports of perceived stress prior to and following the intervention, i.e. at all assessment times.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomised controlled trial testing a brief digital intervention (SeApp) against a control group receiving only EMA
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2022

First Posted

November 15, 2022

Study Start

May 18, 2020

Primary Completion

November 9, 2020

Study Completion

November 9, 2020

Last Updated

November 15, 2022

Record last verified: 2022-11

Locations