Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05617248
Other study ID # SEAPPUZH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT05130944 - Feasibility of Community Psychosocial Intervention for Women N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Completed NCT05881681 - A Mindfulness Approach to UA for Afro-descendants N/A
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A
Recruiting NCT04038190 - A Behavioral Activation Intervention Administered in a College Freshman Orientation Course Phase 2
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Active, not recruiting NCT05998161 - Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout N/A
Completed NCT03728062 - Mindfulness Meditation Versus Physical Exercise: Comparing Effects on Stress and Immunocompetence N/A
Terminated NCT04367636 - The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19 N/A
Completed NCT06405789 - The Effect of Yoga on Mindfulness and Perceived Stress N/A
Recruiting NCT06002074 - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases N/A
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Completed NCT05245409 - Stress, EEG, ECG, and Chiropractic N/A
Completed NCT04722367 - Being Present With Art: The Impact of Mindful Engagement With Art on Awareness and Connection N/A
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Completed NCT06057883 - Effects Of A Probiotic Formulation On Stress and Skin Health in Younger Adult Females Phase 2
Completed NCT05312749 - The Effect of Web Based Progressive Muscle Relaxation Exercise on Clinical Stress and Anxiety of Nursing Students N/A
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Completed NCT05623826 - Feasibility and Efficacy of a Digital Training Intervention to Increase Reward Sensitivity- Imager N/A
Completed NCT04013451 - The Kiss of Kindness Study II N/A