StressSEAPPNCT05617248
Feasibility and Efficacy of a Brief Digital Self-efficacy Training
A study testing Self-efficacy App in people with Stress and Self Efficacy, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Self Efficacy
- What is being tested?
- Self-efficacy App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 May 2020to 9 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- -current psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress, Self Efficacy
- Being tested
- Self-efficacy App
- Keywords
- self-efficacy, stress, digital, intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-efficacy AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Self-efficacy App |
| Control | No intervention | This group will receive EMA questionnaires for one week (10 per day). |
What is being measured
The primary outcome is the main question the study is designed to answer.
General self-efficacy
The General Self-Efficacy Scale (Schwarzer \& Jerusalem, 1995; Tipton \& Worthington, 1984) will measure the general self-efficacy.
Measured: change from baseline to 1 day post intervention; time frame: 1 week
Secondary outcomes (6)
Perceived stress
The Perceived Stress Scale (Cohen, Kamarck, \& Mermelstein, 1983; Klein et al., 2016) will measure perceived stress.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: change from baseline to 1 day post intervention; time frame: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start18 May 2020
- Primary completion9 Nov 2020
- Study completion9 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial testing a brief digital intervention (SeApp) against a control group receiving only EMA
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617248
- Sponsor's protocol ID
- SEAPPUZH
- Acronym
- SEAPP
- Status last verified
- Nov 2022
- First submitted
- 12 Sep 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is planned to make the anonymised data available on a public repository.
Publications
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.
PubMed 39480821Rohde 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.
PubMed 37578827
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of a Brief Digital Self-efficacy Training in University Students With Self-reported Elevated Stress: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05617248
- Acronym / sponsor ID
- SEAPP / SEAPPUZH
- Conditions
- Stress, Self Efficacy
- Keywords
- self-efficacy, stress, digital, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 18 May 2020 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial testing a brief digital intervention (SeApp) against a control group receiving only EMA
| Arm | Type | Receives |
|---|---|---|
| Experimental: Self-efficacy training (App) | Experimental | Behavioral: Self-efficacy AppThis group will receive a digital one week self-efficacy training with three training sessions per day and EMA (10 per day). |
| Control | No intervention | –This group will receive EMA questionnaires for one week (10 per day). |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -current psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-efficacy AppThe 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. | Behavioural | Experimental: Self-efficacy training (App) |
Primary outcome
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.
6 secondary outcomes
Perceived stress
Time frame: change from screening to 1 day post intervention; time frame: 1 week
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.
Hope
Time frame: change from baseline to 1 day post intervention; time frame: 1 week
Depression
Time frame: The Beck Depression Inventory-II (Beck, Steer, Ball, & Ranieri, 1996; Kuhner, Burger, Keller, & Hautzinger, 2007) will measure depression.
Anxiety
Time frame: change from baseline to 1 day post intervention; time frame: 1 week
Hopelessness
Time frame: change from baseline to 1 day post intervention; time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Derived from this study: PubMed 39480821Rohde 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.
- Derived from this study: PubMed 37578827Rohde 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.
- Individual participant dataSharing planned: Undecided. It is planned to make the anonymised data available on a public repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-efficacy App in people with Stress and Self Efficacy, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General self-efficacy (time frame: change from baseline to 1 day post intervention; time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05617248, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.